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1.
Am J Obstet Gynecol ; 2024 Jan 26.
Artículo en Inglés | MEDLINE | ID: mdl-38280434

RESUMEN

OBJECTIVE: This study aimed to investigate whether uterine artery embolization offers a better quality of life than myomectomy in premenopausal women diagnosed with leiomyomas of the uterus. DATA SOURCES: A literature search was performed using the electronic databases of PubMed and Cochrane Central Register of Controlled Trials from inception to January 2023. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials comparing uterine artery embolization with myomectomy in women of premenopausal age suffering from uterine leiomyomas were considered. METHODS: The primary outcome was quality of life. The secondary outcomes were reintervention rate and timing, successful pregnancy, stillbirth and miscarriage, cesarean delivery on delivery, and perioperative morbidity. Moreover, time-to-event and standard pairwise meta-analyses were performed, as appropriate. The certainty of the evidence was assessed in line with the Grading of Recommendations, Assessment, Development, and Evaluations methodology. RESULTS: A total of 6 randomized controlled trials met our inclusion criteria. The meta-analysis suggested little to no difference in terms of quality of life between uterine artery embolization and myomectomy (standard mean difference, 0.05; 95% confidence interval, -0.38 to 0.48; I2=92%; very low certainty of evidence). Sensitivity analysis, including randomized controlled trials, which included solely myomectomy procedures in the control arm, demonstrated better quality of life for women treated with myomectomy (standard mean difference, -0.32; 95% confidence interval, -0.49 to -0.15; I2=15%). Concerning reintervention, myomectomy was likely associated with a decreased risk of future reintervention (risk ratio, 0.32; 95% confidence interval, 0.15-0.69; I2=60%; low certainty of evidence) and a more prolonged time interval since a potential reintervention because of recurrence than uterine artery embolization (hazard ratio, 0.41; 95% confidence interval, 0.22-0.77; I2=77%; low certainty of evidence). No difference was found between the 2 interventions concerning severe perioperative adverse events (relative risk, 4.13; 95% confidence interval, 0.44-39.20; I2=0%; low certainty of evidence). CONCLUSION: Uterine artery embolization is likely associated with increased reintervention rates and less time to reintervention compared with myomectomy in premenopausal women diagnosed with uterine leiomyomas. Evidence suggests no difference between the 2 interventions regarding perioperative morbidity. Uterine artery embolization may exert no effect on quality of life and successful pregnancy; however, the evidence is very uncertain.

2.
Surg Endosc ; 2024 Jun 28.
Artículo en Inglés | MEDLINE | ID: mdl-38942944

RESUMEN

BACKGROUND: As the population ages, more older adults are presenting for surgery. Age-related declines in physiological reserve and functional capacity can result in frailty and poor outcomes after surgery. Hence, optimizing perioperative care in older patients is imperative. Enhanced Recovery After Surgery (ERAS) pathways and Minimally Invasive Surgery (MIS) may influence surgical outcomes, but current use and impact on older adults patients is unknown. The aim of this study was to provide evidence-based recommendations on perioperative care of older adults undergoing major abdominal surgery. METHODS: Expert consensus determined working definitions for key terms and metrics related to perioperative care. A systematic literature review and meta-analysis was performed using the PubMed, Embase, Cochrane Library, and Clinicaltrials.gov databases for 24 pre-defined key questions in the topic areas of prehabilitation, MIS, and ERAS in major abdominal surgery (colorectal, upper gastrointestinal (UGI), Hernia, and hepatopancreatic biliary (HPB)) to generate evidence-based recommendations following the GRADE methodology. RESULT: Older adults were defined as 65 years and older. Over 20,000 articles were initially retrieved from search parameters. Evidence synthesis was performed across the three topic areas from 172 studies, with meta-analyses conducted for MIS and ERAS topics. The use of MIS and ERAS was recommended for older adult patients particularly when undergoing colorectal surgery. Expert opinion recommended prehabilitation, cessation of smoking and alcohol, and correction of anemia in all colorectal, UGI, Hernia, and HPB procedures in older adults. All recommendations were conditional, with low to very low certainty of evidence, with the exception of ERAS program in colorectal surgery. CONCLUSIONS: MIS and ERAS are recommended in older adults undergoing major abdominal surgery, with evidence supporting use in colorectal surgery. Though expert opinion supported prehabilitation, there is insufficient evidence supporting use. This work has identified evidence gaps for further studies to optimize older adults undergoing major abdominal surgery.

3.
Surg Endosc ; 37(9): 6711-6717, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37563340

RESUMEN

BACKGROUND: Operative performance may affect the internal and external validity of randomized trials. The aim of this study was to review the use of surgical quality assurance mechanisms of published trials on laparoscopic anti-reflux surgery, with the objective to appraise their internal (research quality) and external validity (applicability to the clinical setting). METHODS: Building upon a previous systematic review and network meta-analysis published by the authors, Medline, Embase, AMED, CINAHL, CENTRAL, and OpenGrey databases were searched for randomized control trials comparing different methods of laparoscopic anti-reflux surgery for the management of gastroesophageal disease. Quality assurance in individual studies was appraised using a specified framework addressing surgeon accreditation, procedure standardization, and performance monitoring. RESULTS: In total, 2276 articles were screened to obtain 43 publications reporting 29 randomized controlled trials. Twenty-five out of 43 (58.1%) articles reported the number of participating centers and surgeons involved. Additionally, only 21/43 (48.8%) of articles reported consistent use of a bougie, while 23/43 (53.5%) of articles reported consistent division of the short gastric arteries during fundoplication. Surgical experience and credentials were stated in half of the studies. Standardization of the technique was reported in almost 70% of cases, whereas operative notes or video was submitted in one fourth of the studies. Monitoring of the operative performance during the trial was not documented in most of the trials (62%). CONCLUSION: Surgical quality assurance in randomized trials on laparoscopic anti-reflux surgery is insufficient, which does not allow appraisal of the internal and external validity of this research. With improved reporting, trials assessing the use of laparoscopic anti-reflux surgery will enable surgeons to make informed treatment decisions to enhance patient care in the surgical management of GERD.


Asunto(s)
Esofagoplastia , Reflujo Gastroesofágico , Laparoscopía , Humanos , Fundoplicación/métodos , Reflujo Gastroesofágico/cirugía , Reflujo Gastroesofágico/tratamiento farmacológico , Laparoscopía/métodos , Metaanálisis en Red , Resultado del Tratamiento
4.
Surg Endosc ; 37(12): 9013-9029, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37910246

RESUMEN

BACKGROUND: New evidence has emerged since latest guidelines on the management of paraesophageal hernia, and guideline development methodology has evolved. Members of the European Association for Endoscopic Surgery have prioritized the management of paraesophageal hernia to be addressed by pertinent recommendations. OBJECTIVE: To develop evidence-informed clinical practice recommendations on paraesophageal hernias, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: We performed three systematic reviews, and we summarized and appraised the certainty of the evidence using the GRADE methodology. A panel of general and upper gastrointestinal surgeons, gastroenterologists and a patient advocate discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost and use of resources, moderated by a Guidelines International Network-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests surgery over conservative management for asymptomatic/minimally symptomatic paraesophageal hernias (conditional recommendation), and recommends conservative management over surgery for asymptomatic/minimally symptomatic paraesophageal hernias in frail patients (strong recommendation). Further, the panel suggests mesh over sutures for hiatal closure in paraesophageal hernia repair, fundoplication over gastropexy in elective paraesophageal hernia repair, and gastropexy over fundoplication in patients who have cardiopulmonary instability and require emergency paraesophageal hernia repair (conditional recommendation). A strong recommendation means that the proposed course of action is appropriate for the vast majority of patients. A conditional recommendation means that most patients would opt for the proposed course of action, and joint decision-making of the surgeon and the patient is required. Accompanying evidence summaries and evidence-to-decision frameworks should be read when using the recommendations. This guideline applies to adult patients with moderate to large paraesophageal hernias type II to IV with at least 50% of the stomach herniated to the thoracic cavity. The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/j7q7Gn . CONCLUSION: An interdisciplinary panel provides recommendations on key topics on the management of paraesophageal hernias using highest methodological standards and following a transparent process. GUIDELINE REGISTRATION NUMBER: PREPARE-2023CN018.


Asunto(s)
Hernia Hiatal , Laparoscopía , Adulto , Humanos , Fundoplicación/métodos , Enfoque GRADE , Hernia Hiatal/cirugía , Hernia Hiatal/complicaciones , Laparoscopía/métodos , Estómago
5.
Surg Endosc ; 37(12): 9001-9012, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37903883

RESUMEN

BACKGROUND: Variation exists in practice pertaining to bowel preparation before minimally invasive colorectal surgery. A survey of EAES members prioritized this topic to be addressed by a clinical practice guideline. OBJECTIVE: The aim of the study was to develop evidence-informed clinical practice recommendations on the use of bowel preparation before minimally invasive colorectal surgery, through evidence synthesis and a structured evidence-to-decision framework by an interdisciplinary panel of stakeholders. METHODS: This is a collaborative project of EAES, SAGES, and ESCP. We updated a previous systematic review and performed a network meta-analysis of interventions. We appraised the certainty of the evidence for each comparison, using the GRADE and CINeMA methods. A panel of general and colorectal surgeons, infectious diseases specialists, an anesthetist, and a patient representative discussed the evidence in the context of benefits and harms, the certainty of the evidence, acceptability, feasibility, equity, cost, and use of resources, moderated by a GIN-certified master guideline developer and chair. We developed the recommendations in a consensus meeting, followed by a modified Delphi survey. RESULTS: The panel suggests either oral antibiotics alone prior to minimally invasive right colon resection or mechanical bowel preparation (MBP) plus oral antibiotics; MBP plus oral antibiotics prior to minimally invasive left colon and sigmoid resection, and prior to minimally invasive right colon resection when there is an intention to perform intracorporeal anastomosis; and MBP plus oral antibiotics plus enema prior to minimally invasive rectal surgery (conditional recommendations); and recommends MBP plus oral antibiotics prior to minimally invasive colorectal surgery, when there is an intention to localize the lesion intraoperatively (strong recommendation). The full guideline with user-friendly decision aids is available in https://app.magicapp.org/#/guideline/LwvKej . CONCLUSION: This guideline provides recommendations on bowel preparation prior to minimally invasive colorectal surgery for different procedures, using highest methodological standards, through a structured framework informed by key stakeholders. Guideline registration number PREPARE-2023CN045.


Asunto(s)
Catárticos , Neoplasias Colorrectales , Humanos , Catárticos/uso terapéutico , Cuidados Preoperatorios/métodos , Antibacterianos/uso terapéutico , Colon Sigmoide , Infección de la Herida Quirúrgica
6.
Clin Gastroenterol Hepatol ; 20(9): 1931-1946, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-34450297

RESUMEN

BACKGROUND & AIMS: Colonoscopy quality indicators provide measurable assessments of performance, but significant provider-level variations exist. We performed a systematic review and meta-analysis to assess whether endoscopist specialty is associated with adenoma detection rate (ADR) - the primary outcome - or cecal intubation rate, adverse event rates, and post-colonoscopy colorectal cancer rates. METHODS: We searched EMBASE, Google Scholar, MEDLINE, and the Cochrane Central Registry of Controlled Trials from inception to December 14, 2020. Two reviewers independently screened titles and abstracts. Citations underwent duplicate full-text review, with disagreements resolved by a third reviewer. Data were abstracted in duplicate. The DerSimonian and Laird random effects model was used to calculate pooled odds ratios (ORs) with respective 95% confidence intervals (CIs). Risk of bias was assessed using Risk of Bias in Non-randomised Studies of Interventions. RESULTS: Of 11,314 citations, 36 studies representing 3,500,832 colonoscopies were included. Compared with colonoscopies performed by gastroenterologists, those by surgeons were associated with lower ADRs (OR, 0.81; 95% CI, 0.74-0.88) and lower cecal intubation rates (OR, 0.76; 95% CI, 0.63-0.92). Compared with colonoscopies performed by gastroenterologists, those by other (non-gastroenterologist, non-surgeon) endoscopists were associated with lower ADRs (OR, 0.91; 95% CI, 0.87-0.96), higher perforation rates (OR, 3.02; 95% CI, 1.65-5.51), and higher post-colonoscopy colorectal cancer rates (OR, 1.23; 95% CI, 1.14-1.33). Substantial to considerable heterogeneity existed for most analyses, and overall certainty in the evidence was low according to the Grading of Recommendations, Assessment, Development, and Evaluations framework. CONCLUSION: Colonoscopies performed by surgeons or other endoscopists were associated with poorer quality metrics and outcomes compared with those performed by gastroenterologists. Targeted quality improvement efforts may be warranted.


Asunto(s)
Adenoma , Neoplasias Colorrectales , Gastroenterólogos , Ciego , Colonoscopía , Humanos
7.
Br J Surg ; 109(12): 1239-1250, 2022 11 22.
Artículo en Inglés | MEDLINE | ID: mdl-36026550

RESUMEN

BACKGROUND: Incisional hernia is a frequent complication of abdominal wall incision. Surgical technique is an important risk factor for the development of incisional hernia. The aim of these updated guidelines was to provide recommendations to decrease the incidence of incisional hernia. METHODS: A systematic literature search of MEDLINE, Embase, and Cochrane CENTRAL was performed on 22 January 2022. The Scottish Intercollegiate Guidelines Network instrument was used to evaluate systematic reviews and meta-analyses, RCTs, and cohort studies. The GRADE approach (Grading of Recommendations, Assessment, Development and Evaluation) was used to appraise the certainty of the evidence. The guidelines group consisted of surgical specialists, a biomedical information specialist, certified guideline methodologist, and patient representative. RESULTS: Thirty-nine papers were included covering seven key questions, and weak recommendations were made for all of these. Laparoscopic surgery and non-midline incisions are suggested to be preferred when safe and feasible. In laparoscopic surgery, suturing the fascial defect of trocar sites of 10 mm and larger is advised, especially after single-incision laparoscopic surgery and at the umbilicus. For closure of an elective midline laparotomy, a continuous small-bites suturing technique with a slowly absorbable suture is suggested. Prophylactic mesh augmentation after elective midline laparotomy can be considered to reduce the risk of incisional hernia; a permanent synthetic mesh in either the onlay or retromuscular position is advised. CONCLUSION: These updated guidelines may help surgeons in selecting the optimal approach and location of abdominal wall incisions.


An incisional hernia results from a weakness of the abdominal wall muscles that allows fat from the inside or organs to bulge out. These hernias are quite common after abdominal surgery at the site of a previous incision. There is research that discusses different ways to close an incision and this may relate to the chance of hernia formation. The aim of this study was to review the latest research and to provide a guide for surgeons on how best to close incisions to decrease hernia rates. When possible, surgery through small incisions may decrease the risk of hernia formation. If small incisions are used, it may be better if they are placed away from areas that are already weak (such as the belly button). If the incision is larger than 1 cm, it should be closed with a deep muscle-fascia suture in addition to skin sutures. If there is a large incision in the middle of the abdomen, the muscle should be sutured using small stitches that are close together and a slowly absorbable suture should be used. For patients who are at higher risk of developing hernias, when closing the incision, the muscle layer can be strengthened by using a piece of (synthetic) mesh. There is no good research available on recovery after surgery and no clear guides on activity level or whether a binder will help prevent hernia formation.


Asunto(s)
Técnicas de Cierre de Herida Abdominal , Hernia Incisional , Humanos , Pared Abdominal/cirugía , Técnicas de Cierre de Herida Abdominal/efectos adversos , Hernia Incisional/epidemiología , Hernia Incisional/prevención & control , Hernia Incisional/cirugía , Laparotomía , Técnicas de Sutura , Guías de Práctica Clínica como Asunto
8.
Eur J Vasc Endovasc Surg ; 63(2): 323-334, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-35086761

RESUMEN

OBJECTIVE: To investigate the outcomes of treatment strategies for proximal and iliofemoral deep vein thrombosis (DVT). METHODS: Randomised controlled trials (RCTs) investigating outcomes of catheter directed thrombolysis (CDT), ultrasound assisted CDT (USCDT), percutaneous aspiration thrombectomy (PAT), and best medical therapy (BMT) for proximal DVT from 2000 onwards were considered. MEDLINE, EMBASE, and CINAHL were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence. The primary outcome was the rate of post-thrombotic syndrome (PTS), which was defined using the Villalta scoring system (score of ≥5). Secondary outcomes included vessel patency, recurrence, bleeding, and mortality. The network of evidence was summarised using network plots, and random effects network meta-analyses were performed. The certainty of evidence was assessed using the Certainty In Network Meta-Analysis (CINeMA) approach. RESULTS: Seven RCTs meeting the inclusion criteria were identified. There were direct comparisons between medical therapy, CDT, and USCDT across outcomes, except for patency. There were no direct comparisons between medical therapy and PAT (except for patency), and USCDT and PAT. There was no significant difference observed in PTS between the treatment modalities for proximal and iliofemoral DVT (low certainty). There was a significant difference in patency rates between medical therapy and USCDT (odds ratio [OR] 9.46, 95% confidence interval [CI] 3.05 - 29.35; low certainty) and CDT (OR 2.03, 95% CI 1.46 - 2.80; low certainty) in favour of USCDT and CDT, respectively, for proximal DVT. USCDT significantly improved patency rates compared with CDT (OR 4.67, 95% CI 1.58 - 13.81; very low certainty) for proximal DVT. There was no significant difference in DVT recurrence, bleeding, or mortality between treatment groups for proximal and iliofemoral DVT (low to moderate certainty for most comparisons). CONCLUSION: USCDT may improve patency rates compared with BMT and the other interventional treatment modalities used for the management of proximal DVT. However, no treatment modality showed superiority with regard to a reduction in PTS, and overall, the quality of available evidence is poor.


Asunto(s)
Trombolisis Mecánica/métodos , Síndrome Postrombótico/epidemiología , Trombectomía/métodos , Terapia Trombolítica/métodos , Trombosis de la Vena/terapia , Anticoagulantes/uso terapéutico , Humanos , Metaanálisis en Red , Síndrome Postrombótico/etiología , Síndrome Postrombótico/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Trombosis de la Vena/complicaciones
9.
Surg Endosc ; 36(8): 5547-5558, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35705753

RESUMEN

BACKGROUND: The Appraisal of Guidelines Research and Evaluation (AGREE) II instrument was developed to evaluate the quality of clinical practice guidelines. Evidence suggests that development, reporting, and appraisal of guidelines on surgical interventions may be better informed by modification of the instrument. OBJECTIVE: We aimed to develop an AGREE II extension specifically designed for appraisal of guidelines of surgical interventions. METHODS: In a three-part project funded by the United European Gastroenterology and the European Association for Endoscopic Surgery, (i) we identified factors that were associated with higher quality of surgical guidelines, (ii) we statistically calibrated the AGREE II instrument in the context of surgical guidelines using correlation, reliability, and factor analysis, and (iii) we undertook a Delphi consensus process of stakeholders to inform the development of an AGREE II extension instrument for surgical interventions. RESULTS: Several features were prioritized by stakeholders as of particular importance for guidelines of surgical interventions, including development of a guideline protocol, consideration of practice variability and surgical expertise in different settings, and specification of infrastructures required to implement the recommendations. The AGREE-S-AGREE II extension instrument for surgical interventions has 25 items, compared to the 23 items of the original AGREE II instrument, organized into the following 6 domains: Scope and purpose, Stakeholders, Evidence synthesis, Development of recommendations, Editorial independence, and Implementation and update. As the original instrument, it concludes with an overall appraisal of the quality of the guideline and a judgement on whether the guideline is recommended for use. Several items were amended and rearranged among domains, and an item was deleted. The Rigor of Development domain of the original AGREE II was divided into Evidence Synthesis and Development of Recommendations. Items of the AGREE II domain Clarity of Presentation were incorporated in the new domain Development of Recommendations. Three new items were introduced, addressing the development of a guideline protocol, support by a guideline methodologist, and consideration of surgical experience/expertise. CONCLUSION: The AGREE-S appraisal instrument has been developed to be used for assessment of the methodological and reporting quality of guidelines on surgical interventions.


Asunto(s)
Reproducibilidad de los Resultados , Consenso , Humanos
10.
Surg Endosc ; 36(4): 2221-2232, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-35212821

RESUMEN

BACKGROUND: Evidence and practice recommendations on the use of transanal total mesorectal excision (TaTME) for rectal cancer are conflicting. OBJECTIVE: We aimed to summarize best evidence and develop a rapid guideline using transparent, trustworthy, and standardized methodology. METHODS: We developed a rapid guideline in accordance with GRADE, G-I-N, and AGREE II standards. The steering group consisted of general surgeons, members of the EAES Research Committee/Guidelines Subcommittee with expertise and experience in guideline development, advanced medical statistics and evidence synthesis, biostatisticians, and a guideline methodologist. The guideline panel consisted of four general surgeons practicing colorectal surgery, a radiologist with expertise in rectal cancer, a radiation oncologist, a pathologist, and a patient representative. We conducted a systematic review and the results of evidence synthesis by means of meta-analyses were summarized in evidence tables. Recommendations were authored and published through an online authoring and publication platform (MAGICapp), with the guideline panel making use of an evidence-to-decision framework and a Delphi process to arrive at consensus. RESULTS: This rapid guideline provides a weak recommendation for the use of TaTME over laparoscopic or robotic TME for low rectal cancer when expertise is available. Furthermore, it details evidence gaps to be addressed by future research and discusses policy considerations. The guideline, with recommendations, evidence summaries, and decision aids in user-friendly formats can also be accessed in MAGICapp: https://app.magicapp.org/#/guideline/4494 . CONCLUSIONS: This rapid guideline provides evidence-informed trustworthy recommendations on the use of TaTME for rectal cancer.


Asunto(s)
Laparoscopía , Proctectomía , Neoplasias del Recto , Cirugía Endoscópica Transanal , Enfoque GRADE , Humanos , Laparoscopía/métodos , Complicaciones Posoperatorias/cirugía , Neoplasias del Recto/cirugía , Recto/cirugía , Cirugía Endoscópica Transanal/métodos
11.
Surg Endosc ; 36(11): 7863-7876, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36229556

RESUMEN

BACKGROUND: Choledocholithiasis presents in a considerable proportion of patients with gallbladder disease. There are several management options, including preoperative or intraoperative endoscopic cholangiopancreatography (ERCP), and laparoscopic common bile duct exploration (LCBDE). OBJECTIVE: To develop evidence-informed, interdisciplinary, European recommendations on the management of common bile duct stones in the context of intact gallbladder with a clinical decision to intervene to both the gallbladder and the common bile duct stones. METHODS: We updated a systematic review and network meta-analysis of LCBDE, preoperative, intraoperative, and postoperative ERCP. We formed evidence summaries using the GRADE and the CINeMA methodology, and a panel of general surgeons, gastroenterologists, and a patient representative contributed to the development of a GRADE evidence-to-decision framework to select among multiple interventions. RESULTS: The panel reached unanimous consensus on the first Delphi round. We suggest LCBDE over preoperative, intraoperative, or postoperative ERCP, when surgical experience and expertise are available; intraoperative ERCP over LCBDE, preoperative or postoperative ERCP, when this is logistically feasible in a given healthcare setting; and preoperative ERCP over LCBDE or postoperative ERCP, when intraoperative ERCP is not feasible and there is insufficient experience or expertise with LCBDE (weak recommendation). The evidence summaries and decision aids are available on the platform MAGICapp ( https://app.magicapp.org/#/guideline/nJ5zyL ). CONCLUSION: We developed a rapid guideline on the management of common bile duct stones in line with latest methodological standards. It can be used by healthcare professionals and other stakeholders to inform clinical and policy decisions. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN170.


Asunto(s)
Colecistectomía Laparoscópica , Coledocolitiasis , Cálculos Biliares , Humanos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Colecistectomía Laparoscópica/métodos , Enfoque GRADE , Metaanálisis en Red , Películas Cinematográficas , Coledocolitiasis/cirugía , Cálculos Biliares/cirugía , Conducto Colédoco/cirugía
12.
Surg Endosc ; 36(12): 8699-8712, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-36307599

RESUMEN

BACKGROUND: Clinical practice recommendations for the management of acute appendicitis in pregnancy are lacking. OBJECTIVE: To develop an evidence-informed, trustworthy guideline on the management of appendicitis in pregnancy. We aimed to address the questions of conservative or surgical management, and laparoscopic or open surgery for acute appendicitis. METHODS: We performed a systematic review, meta-analysis, and evidence appraisal using the GRADE methodology. A European, multidisciplinary panel of surgeons, obstetricians/gynecologists, a midwife, and 3 patient representatives reached consensus through an evidence-to-decision framework and a Delphi process to formulate the recommendations. The project was developed in an online authoring and publication platform (MAGICapp). RESULTS: Research evidence was of very low certainty. We recommend operative treatment over conservative management in pregnant patients with complicated appendicitis or appendicolith on imaging studies (strong recommendation). We suggest operative treatment over conservative management in pregnant patients with uncomplicated appendicitis and no appendicolith on imaging studies (weak recommendation). We suggest laparoscopic appendectomy in patients with acute appendicitis until the 20th week of gestation, or when the fundus of the uterus is below the level of the umbilicus; and laparoscopic or open appendectomy in patients with acute appendicitis beyond the 20th week of gestation, or when the fundus of the uterus is above the level of the umbilicus, depending on the preference and expertise of the surgeon. CONCLUSION: Through a structured, evidence-informed approach, an interdisciplinary panel provides a strong recommendation to perform appendectomy for complicated appendicitis or appendicolith, and laparoscopic or open appendectomy beyond the 20th week, based on the surgeon's preference and expertise. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN210.


Asunto(s)
Apendicitis , Laparoscopía , Embarazo , Femenino , Humanos , Apendicitis/cirugía , Enfoque GRADE , Apendicectomía/métodos , Laparoscopía/métodos , Enfermedad Aguda
13.
Surg Endosc ; 36(3): 1709-1725, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-35059839

RESUMEN

BACKGROUND: The European Association for Endoscopic Surgery Bariatric Guidelines Group identified a gap in bariatric surgery recommendations with a structured, contextualized consideration of multiple bariatric interventions. OBJECTIVE: To provide evidence-informed, transparent and trustworthy recommendations on the use of sleeve gastrectomy, Roux-en-Y gastric bypass, adjustable gastric banding, gastric plication, biliopancreatic diversion with duodenal switch, one anastomosis gastric bypass, and single anastomosis duodeno-ileal bypass with sleeve gastrectomy in patients with severe obesity and metabolic diseases. Only laparoscopic procedures in adults were considered. METHODS: A European interdisciplinary panel including general surgeons, obesity physicians, anesthetists, a psychologist and a patient representative informed outcome importance and minimal important differences. We conducted a systematic review and frequentist fixed and random-effects network meta-analysis of randomized-controlled trials (RCTs) using the graph theory approach for each outcome. We calculated the odds ratio or the (standardized) mean differences with 95% confidence intervals for binary and continuous outcomes, respectively. We assessed the certainty of evidence using the CINeMA and GRADE methodologies. We considered the risk/benefit outcomes within a GRADE evidence to decision framework to arrive at recommendations, which were validated through an anonymous Delphi process of the panel. RESULTS: We identified 43 records reporting on 24 RCTs. Most network information surrounded sleeve gastrectomy and Roux-en-Y gastric bypass. Under consideration of the certainty of the evidence and evidence to decision parameters, we suggest sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass over adjustable gastric banding, biliopancreatic diversion with duodenal switch and gastric plication for the management of severe obesity and associated metabolic diseases. One anastomosis gastric bypass and single anastomosis duodeno-ileal bypass with sleeve gastrectomy are suggested as alternatives, although evidence on benefits and harms, and specific selection criteria is limited compared to sleeve gastrectomy and Roux-en-Y gastric bypass. The guideline, with recommendations, evidence summaries and decision aids in user friendly formats can also be accessed in MAGICapp:  https://app.magicapp.org/#/guideline/Lpv2kE CONCLUSIONS: This rapid guideline provides evidence-informed, pertinent recommendations on the use of bariatric and metabolic surgery for the management of severe obesity and metabolic diseases. The guideline replaces relevant recommendations published in the EAES Bariatric Guidelines 2020.


Asunto(s)
Cirugía Bariátrica , Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Adulto , Humanos , Cirugía Bariátrica/métodos , Consenso , Gastrectomía/métodos , Derivación Gástrica/métodos , Enfoque GRADE , Laparoscopía/métodos , Películas Cinematográficas , Metaanálisis en Red , Obesidad Mórbida/cirugía , Resultado del Tratamiento
14.
Eur J Vasc Endovasc Surg ; 61(3): 383-394, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33309488

RESUMEN

OBJECTIVE: To investigate whether a percutaneous approach has better clinical outcomes than surgical access for standard endovascular repair of abdominal aortic aneurysms. DATA SOURCES: MEDLINE and Embase were searched using the Healthcare Databases Advanced Search interface developed by the National Institute for Health and Care Excellence. REVIEW METHODS: Randomised controlled trials (RCTs) that compared percutaneous and cutdown endovascular aneurysm repair (EVAR) were considered. Pooled effect estimates were calculated using the odds ratio (OR), risk difference, or mean difference (MD) and 95% confidence interval (CI). The Mantel-Haenszel or inverse variance statistical method was used as appropriate. Trial sequential analysis was performed to quantify the available evidence and control for the risk of type 1 and type 2 error. Risk of bias was assessed with the revised tool developed by Cochrane and the quality of evidence was graded using the GRADE system (Grades of Recommendation, Assessment, Development and Evaluation). RESULTS: Four RCTs were identified, reporting a total of 368 patients and 530 access sites. Meta-analysis showed no difference in access site complications or infection, post-operative bleeding/haematoma, access related arterial injury, femoral artery occlusion, pseudo-aneurysm, or peri-operative mortality between percutaneous and cutdown EVAR. Seroma/lymphorrhoea was significantly less frequent after percutaneous EVAR (0%) compared with cutdown EVAR (3%; OR 0.18 [95% CI 0.04-0.83]) and the procedure time was significantly shorter (MD -11.53 minutes; 95% CI -15.71-7.34), but hospital length of stay was not different between treatments. Neither the O'Brien-Fleming boundaries nor the futility boundaries were crossed by the cumulative Z curve, and the required information size was not reached for any of the outcomes. All trials were judged to be high risk of bias or have some concerns, and the level of the body of evidence was low or very low for all outcomes. CONCLUSION: The evidence is very uncertain about the effect of percutaneous EVAR on clinically important outcomes.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Procedimientos Endovasculares , Complicaciones Posoperatorias/epidemiología , Implantación de Prótesis Vascular , Humanos
15.
Eur J Vasc Endovasc Surg ; 61(2): 228-237, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33288434

RESUMEN

OBJECTIVE: The aim of this review was to investigate comparative outcomes of fenestrated or branched endovascular aneurysm repair (F/BEVAR) with open repair for juxta/para/suprarenal or thoraco-abdominal aortic aneurysms. METHODS: Electronic bibliographic sources (MEDLINE and Embase) were interrogated using the Healthcare Databases Advanced Search interface. Eligible studies compared F/BEVAR with open repair for complex aortic aneurysms using propensity score or Cox regression modelling/multivariable logistic regression analysis. Pooled estimates of peri-operative outcomes were calculated using the odds ratio (OR) and 95% confidence interval (CI). The result of time to event analysis was reported as summary hazard ratio (HR) and 95% CI. Random effects models and the inverse variance method were applied. The quality of evidence was graded using the system developed by the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) working group. RESULTS: Eleven studies published between 2014 and 2019 were selected for inclusion in qualitative and quantitative synthesis reporting a total of at least 7 061 patients. The odds of peri-operative mortality after F/BEVAR were lower, although not significantly, than after open repair (OR 0.56, 95% CI 0.28-1.12), whereas the hazard of overall mortality during follow up was higher following F/BEVAR, but, again, without reaching statistical significance (HR 1.25, 95% CI 0.93-1.67). The hazard of re-intervention was significantly higher after endovascular therapy (HR 2.11, 95% CI 1.39-3.18). The certainty for the body of evidence for peri-operative and overall mortality during follow up was judged to be very low and moderate, respectively, and for re-intervention it was judged to be high. CONCLUSION: The evidence is uncertain about the effect of F/BEVAR on peri-operative mortality when compared with open repair. There is probably no difference in overall survival, but F/BEVAR results in an increased re-intervention hazard. There is a need for high level evidence to inform decision making and vascular/aortic service provision.


Asunto(s)
Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular/métodos , Procedimientos Endovasculares/métodos , Humanos , Puntaje de Propensión , Resultado del Tratamiento
16.
Surg Endosc ; 35(3): 1238-1246, 2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-32240381

RESUMEN

BACKGROUND: Over the past 25 years, the European Association for Endoscopic Surgery (EAES) has been issuing clinical guidance documents to aid surgical practice. We aimed to investigate the awareness and use of such documents among EAES members. Additionally, we conceptually appraised the methodology used in their development in order to propose a bundle of actions for quality improvement and increased penetration of clinical practice guidelines among EAES members. METHODS: We invited members of EAES to participate in a web-based survey on awareness and use of these documents. Post hoc analyses were performed to identify factors associated with poor awareness/use and the reported reasons for limited use. We further summarized and conceptually analyzed key methodological features of clinical guidance documents published by EAES. RESULTS: Three distinct consecutive phases of methodological evolvement of clinical guidance documents were evident: a "consensus phase," a "guideline phase," and a "transitional phase". Out of a total of 254 surgeons who completed the survey, 72% percent were aware of EAES guidelines and 47% reported occasional use. Young age and trainee status were associated with poor awareness and use. Restriction by colleagues was the primary reason for limited use in these subgroups. CONCLUSIONS: The methodology of EAES clinical guidance documents is evolving. Awareness among EAES members is fair, but use is limited. Dissemination actions should be directed to junior surgeons and trainees.


Asunto(s)
Endoscopía/métodos , Adulto , Consenso , Estudios de Evaluación como Asunto , Humanos , Persona de Mediana Edad , Encuestas y Cuestionarios
17.
Surg Endosc ; 35(7): 3670-3678, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-32767145

RESUMEN

BACKGROUND: AirSeal® is a valve-free insufflation system that enables a stable pneumoperitoneum with continuous smoke evacuation and CO2 recirculation during laparoscopic surgery. Comparative evidence on the use of AirSeal® and standard CO2 insufflator in laparoscopic general surgery procedures is scarce. The aim of this study was to compare surgical outcomes between AirSeal® and standard CO2 insufflators in patients undergoing the most frequently performed laparoscopic procedures. METHODS: One hundred and ninety-eight patients undergoing elective laparoscopic cholecystectomy, colorectal surgery and hernia repair were randomized to either AirSeal® (group A) or standard pressure CO2 insufflator (group S). The primary endpoints were operative time and level of postoperative shoulder tip pain (Visual Analog Scale). Secondary outcomes included Clavien-Dindo grade complications, surgical side effect and length of hospital stay. RESULTS: Patients were randomized to either group A (n = 101) or group S (n = 97) and were analyzed by intention-to-treat. There was no significant difference in mean operative time between the groups (median [IQR]; 71 min [56-94] in group A vs. 69 min [52-93] in group S; p = 0.434). Shoulder tip pain levels were significantly lower in group S (VAS 0 [0-3] in group S vs. 2 [0-4] in group A; p = 0.001). There was no significant difference in complications, surgical side effects (subcutaneous emphysema was not observed in any group) and length of hospital stay. CONCLUSION: This randomized controlled trial showed that using the AirSeal® system did not reduce operative time and was associated with a higher postoperative shoulder tip pain compared to standard CO2 insufflator for short elective surgeries. ClinicalTrials.gov (NCT01740011).


Asunto(s)
Colecistectomía Laparoscópica , Insuflación , Laparoscopía , Neumoperitoneo , Dióxido de Carbono , Colecistectomía Laparoscópica/efectos adversos , Humanos , Dolor Postoperatorio/epidemiología , Dolor Postoperatorio/etiología , Dolor Postoperatorio/prevención & control , Neumoperitoneo Artificial/efectos adversos , Estudios Prospectivos
18.
Surg Endosc ; 35(8): 4061-4068, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34159464

RESUMEN

OBJECTIVE: To inform the development of an AGREE II extension specifically tailored for surgical guidelines. AGREE II was designed to inform the development, reporting, and appraisal of clinical practice guidelines. Previous research has suggested substantial room for improvement of the quality of surgical guidelines. METHODS: A previously published search in MEDLINE for clinical practice guidelines published by surgical scientific organizations with an international scope between 2008 and 2017, resulted in a total of 67 guidelines. The quality of these guidelines was assessed using AGREE II. We performed a series of statistical analyses (reliability, correlation and Factor Analysis, Item Response Theory) with the objective to calibrate AGREE II for use specifically in surgical guidelines. RESULTS: Reliability/correlation/factor analysis and Item Response Theory produced similar results and suggested that a structure of 5 domains, instead of 6 domains of the original instrument, might be more appropriate. Furthermore, exclusion and re-arrangement of items to other domains was found to increase the reliability of AGREE II when applied in surgical guidelines. CONCLUSIONS: The findings of this study suggest that statistical calibration of AGREE II might improve the development, reporting, and appraisal of surgical guidelines.


Asunto(s)
Proyectos de Investigación , Calibración , Análisis Factorial , Humanos , Reproducibilidad de los Resultados
19.
Surg Endosc ; 35(7): 3233-3243, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-33999255

RESUMEN

BACKGROUND: There is a lack of trustworthy evidence-informed guidelines on the diagnosis and management of acute appendicitis in elderly patients. METHODS: We developed a rapid guideline in accordance with GRADE and AGREE II standards. The steering group consisted of general surgeons, members of the EAES Research Committee/Guidelines Subcommittee with expertise and experience in guideline development, advanced medical statistics and evidence synthesis, biostatisticians, and a guideline methodologist. The guideline panel consisted of three general surgeons, an intensive care physician, a geriatrician and a patient advocate. We conducted systematic reviews and the results of evidence synthesis were summarized in evidence tables. Recommendations were authored and published through an online authoring and publication platform (MAGICapp), with the guideline panel making use of an evidence-to-decision framework and a Delphi process to arrive at consensus. RESULTS: This rapid guideline provides a weak recommendation against the use of clinical scoring systems to replace cross-sectional imaging in the diagnostic approach of suspected appendicitis in elderly patients. It provides a weak recommendation against the use of antibiotics alone over surgical treatment in patients who are deemed fit for surgery, and a weak recommendation for laparoscopic over open surgery. Furthermore, it provides a summary of surgery-associated risks in elderly patients. The guidelines, with recommendations, evidence summaries and decision aids in user-friendly formats can also be accessed in MAGICapp: https://app.magicapp.org/#/guideline/4494 . CONCLUSIONS: This rapid guideline provides evidence-informed trustworthy recommendations on the diagnosis and management of acute appendicitis in elderly patients.


Asunto(s)
Apendicitis , Laparoscopía , Enfermedad Aguda , Anciano , Apendicitis/diagnóstico , Apendicitis/cirugía , Humanos
20.
Surg Endosc ; 35(1): 1-17, 2021 01.
Artículo en Inglés | MEDLINE | ID: mdl-33170335

RESUMEN

BACKGROUND: COVID-19 pandemic presented an unexpected challenge for the surgical community in general and Minimally Invasive Surgery (MIS) specialists in particular. This document aims to summarize recent evidence and experts' opinion and formulate recommendations to guide the surgical community on how to best organize the recovery plan for surgical activity across different sub-specialities after the COVID-19 pandemic. METHODS: Recommendations were developed through a Delphi process for establishment of expert consensus. Domain topics were formulated and subsequently subdivided into questions pertinent to different surgical specialities following the COVID-19 crisis. Sixty-five experts from 24 countries, representing the entire EAES board, were invited. Fifty clinicians and six engineers accepted the invitation and drafted statements based on specific key questions. Anonymous voting on the statements was performed until consensus was achieved, defined by at least 70% agreement. RESULTS: A total of 92 consensus statements were formulated with regard to safe resumption of surgery across eight domains, addressing general surgery, upper GI, lower GI, bariatrics, endocrine, HPB, abdominal wall and technology/research. The statements addressed elective and emergency services across all subspecialties with specific attention to the role of MIS during the recovery plan. Eighty-four of the statements were approved during the first round of Delphi voting (91.3%) and another 8 during the following round after substantial modification, resulting in a 100% consensus. CONCLUSION: The recommendations formulated by the EAES board establish a framework for resumption of surgery following COVID-19 pandemic with particular focus on the role of MIS across surgical specialities. The statements have the potential for wide application in the clinical setting, education activities and research work across different healthcare systems.


Asunto(s)
COVID-19 , Control de Infecciones/normas , Procedimientos Quirúrgicos Mínimamente Invasivos/normas , COVID-19/epidemiología , COVID-19/prevención & control , Técnica Delphi , Procedimientos Quirúrgicos Electivos/métodos , Procedimientos Quirúrgicos Electivos/normas , Urgencias Médicas , Salud Global , Asignación de Recursos para la Atención de Salud/normas , Accesibilidad a los Servicios de Salud/normas , Humanos , Control de Infecciones/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Pandemias , SARS-CoV-2
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