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1.
JAMA Surg ; 2024 Apr 17.
Artigo em Inglês | MEDLINE | ID: mdl-38630471

RESUMO

Importance: Current short-term evidence has shown that uncomplicated acute appendicitis can be treated successfully with oral antibiotics alone, but longer-term results are lacking. Objective: To assess the treatment effectiveness of oral antibiotic monotherapy compared with combined intravenous (IV) and oral antibiotics in computed tomography-confirmed uncomplicated acute appendicitis at a longer-term follow-up. Design, Setting, and Participants: This secondary analysis of a predefined year 3 follow-up of the Appendicitis Acuta II (APPAC II) noninferiority, multicenter randomized clinical trial compared oral moxifloxacin with combined IV ertapenem plus oral levofloxacin and metronidazole for the treatment of uncomplicated acute appendicitis. The trial was conducted at 9 university and central hospitals in Finland from April 2017 to November 2018, with the last follow-up in November 2022. Participants included patients aged 18 to 60 years, who were randomized to receive either oral antibiotics monotherapy (n = 301) or combined IV and oral antibiotics (n = 298). Interventions: Antibiotics monotherapy consisted of oral moxifloxacin, 400 mg/d, for 7 days. Combined IV and oral antibiotics consisted of IV ertapenem sodium, 1 g/d, for 2 days plus oral levofloxacin, 500 mg/d, and metronidazole, 500 mg 3 times/d, for 5 days. Main Outcomes and Measures: The primary end point was treatment success, defined as the resolution of acute appendicitis and discharge from hospital without the need for surgical intervention and no appendicitis recurrence at the year 3 follow-up evaluated using a noninferiority design. The secondary end points included late (after 1 year) appendicitis recurrence as well as treatment-related adverse events, quality of life, length of hospital stay, and length of sick leave, which were evaluated using a superiority design. Results: After exclusions, 599 patients (mean [SD] age, 36 [12] years; 336 males [56.1%]) were randomized; after withdrawal and loss to follow-up, 582 patients (99.8%) were available for the year 3 follow-up. The treatment success at year 3 was 63.4% (1-sided 95% CI, 58.8% to ∞) in the oral antibiotic monotherapy group and 65.2% (1-sided 95% CI, 60.5% to ∞) in the combined IV and oral antibiotics group. The difference in treatment success rate between the groups at year 3 was -1.8 percentage points (1-sided 95% CI, -8.3 percentage points to ∞; P = .14 for noninferiority), with the CI limit exceeding the noninferiority margin. There were no significant differences between groups in treatment-related adverse events, quality of life, length of hospital stay, or length of sick leave. Conclusions and Relevance: This secondary analysis of the APPAC II trial found a slightly higher appendectomy rate in patients who received oral antibiotic monotherapy; however, noninferiority of oral antibiotic monotherapy compared with combined IV and oral antibiotics could not be demonstrated. The results encourage future studies to assess oral antibiotic monotherapy as a viable treatment alternative for uncomplicated acute appendicitis. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961.

2.
J Adv Res ; 2024 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-38458256

RESUMO

INTRODUCTION: Gut microbiome-derived nanoparticles, known as bacterial extracellular vesicles (bEVs), have garnered interest as promising tools for studying the link between the gut microbiome and human health. The diverse composition of bEVs, including their proteins, mRNAs, metabolites, and lipids, makes them useful for investigating diseases such as cancer. However, conventional approaches for studying gut microbiome composition alone may not be accurate in deciphering host-gut microbiome communication. In clinical microbiome research, there is a gap in the knowledge on the role of bEVs in solid tumor patients. OBJECTIVES: Analyzing the functionality of bEVs using (meta)genomics and proteomics could highlight the unique aspects of host-gut microbiome interactions in solid tumor patients. Therefore, we performed a comparative analysis of the proteome and microbiota composition of gut microbiome-derived bEVs isolated from patients with solid tumors and healthy controls. METHODS: After isolating bEVs from the feces of solid tumor patients and healthy controls, we performed spectrometry analysis of their proteomes and next-generation sequencing (NGS) of the 16S gene. We also investigated the gut microbiomes of feces from patients and controls using 16S sequencing and used machine learning to classify the samples into patients and controls based on their bEVs and fecal microbiomes. RESULTS: Solid tumor patients showed decreased microbiota richness and diversity in both the bEVs and feces. However, the bEV proteomes were more diverse in patients than in the controls and were enriched with proteins associated with the metabolism of amino acids and carbohydrates, nucleotide binding, and oxidoreductase activity. Metadata classification of samples was more accurate using fecal bEVs (100%) compared with fecal samples (93%). CONCLUSION: Our findings suggest that bEVs are unique functional entities. There is a need to explore bEVs together with conventional gut microbiome analysis in functional cancer research to decipher the potential of bEVs as cancer diagnostic or therapeutic biomarkers.

4.
Br J Surg ; 111(1)2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-37944025

RESUMO

BACKGROUND: The rate of incisional hernia after closure of a temporary loop ileostomy is significant. Synthetic meshes are still commonly avoided in contaminated wounds. The Preloop trial was a multicentre RCT designed to evaluate the benefits of synthetic mesh in incisional hernia prevention, and its safety for use in a contaminated surgical site compared with biological mesh. METHODS: Study patients who underwent closure of a loop ileostomy after anterior resection for rectal cancer were assigned to receive either retrorectus synthetic or biological mesh to prevent incisional hernia. The primary outcomes were surgical-site infections within 30 days, and clinical or radiological incisional hernia incidence at 10 months. Secondary outcomes were reoperation rate, operating time, duration of hospital stay, other complications within 30 days of surgery, 5-year quality of life measured by RAND-36, and incisional hernia incidence within 5 years of follow-up. RESULTS: Between November 2018 and September 2021, 102 patients were randomised, of whom 97 received the intended allocation. At 10-month follow-up, 90 patients had undergone clinical evaluation and 88 radiological evaluation. One patient in each group (2 per cent) had a clinical diagnosis of incisional hernia (P = 0.950) and one further patient in each group had a CT-confirmed incisional hernia (P = 0.949). The number of other complications, reoperation rate, operating time, and duration of hospital stay did not differ between the study groups. CONCLUSION: Synthetic mesh appeared comparable to biological mesh in efficacy and safety for incisional hernia prevention at the time of loop ileostomy closure. REGISTRATION NUMBER: NCT03445936 (http://www.clinicaltrials.gov).


Assuntos
Hérnia Incisional , Humanos , Ileostomia/efeitos adversos , Hérnia Incisional/etiologia , Hérnia Incisional/prevenção & controle , Hérnia Incisional/epidemiologia , Qualidade de Vida , Telas Cirúrgicas/efeitos adversos , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controle
5.
Acta Obstet Gynecol Scand ; 102(12): 1634-1642, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37814355

RESUMO

INTRODUCTION: Chronic pelvic pain (CPP) affects over one fifth of women worldwide, and endometriosis is one of the most common causes. In the present study, we examined whether sacral neuromodulation (SNM) is effective in the treatment of refractory chronic pelvic pain in women with endometriosis. MATERIAL AND METHODS: This multicenter prospective pilot study was started in 2017 and includes patients with chronic pelvic pain with no other obvious pathology than endometriosis. Other treatment options have been tried or they are unsuitable. Patients underwent SNM implantation. The main outcome was postoperative pain reduction and secondary outcome was quality of life. The following questionnaires were used to assess the outcomes: Brief pain inventory (BPI), clinical global impression - improvement (CGI-I), 15D-measure of health-related quality of life, and Biberoglu and Behrman (B&B) score. RESULTS: A total of 35 patients underwent the SNM procedure and, at the time of analysis, 15 patients had returned one-year questionnaires. The patients had a history of endometriosis for a median of 5.5 (interquartile range 2-9) years, with no correlation between the severity of symptoms and the duration of the disease (p = 0.158). A total of 31 patients (89%) were implanted with the internal pulse generator. There were statistically significant changes in BPI pain-related items. Worst experienced daily pain decreased among those who returned 12-month questionnaires from median 9 to 5 (p = 0.006), average daily pain from 6 to 3.5 (p = 0.004), and least daily pain from 3 to 1 (p = 0.004). Based on the CGI questionnaire (n = 14), at 12 months nine patients (60%) experienced great improvement in their symptoms, three patients (20%) much improvement and two patients (13%) minimal improvement. None of the patients experienced worsening of their symptoms. There was a statistically significant change in overall 15D score at 1 month (p < 0.001), 6 months (p = 0.001) and 12 months (p = 0.018), when the results were compared to baseline values. Median B&B score also improved significantly and decreased from a baseline value of 8 (4-12) to 4.5 (0-6), p = 0.002. CONCLUSIONS: Based on the preliminary findings of our study, SNM might be a promising treatment of CPP in endometriosis patients.


Assuntos
Dor Crônica , Terapia por Estimulação Elétrica , Endometriose , Humanos , Feminino , Endometriose/complicações , Endometriose/terapia , Estudos Prospectivos , Qualidade de Vida , Projetos Piloto , Dor Pélvica/etiologia , Dor Pélvica/terapia , Resultado do Tratamento , Dor Crônica/etiologia , Dor Crônica/terapia
7.
Br J Surg ; 110(9): 1153-1160, 2023 08 11.
Artigo em Inglês | MEDLINE | ID: mdl-37289913

RESUMO

BACKGROUND: The impact of method of anastomosis and minimally invasive surgical technique on surgical and clinical outcomes after right hemicolectomy is uncertain. The aim of the MIRCAST study was to compare intracorporeal and extracorporeal anastomosis (ICA and ECA respectively), each using either a laparoscopic approach or robot-assisted surgery during right hemicolectomies for benign or malignant tumours. METHODS: This was an international, multicentre, prospective, observational, monitored, non-randomized, parallel, four-cohort study (laparoscopic ECA; laparoscopic ICA; robot-assisted ECA; robot-assisted ICA). High-volume surgeons (at least 30 minimally invasive right colectomy procedures/year) from 59 hospitals across 12 European countries treated patients over a 3-year interval The primary composite endpoint was 30-day success, defined by two measures of efficacy-absence of surgical wound infection and of any major complication within the first 30 days after surgery. Secondary outcomes were: overall complications, conversion rate, duration of operation, and number of lymph nodes harvested. Propensity score analysis was used for comparison of ICA with ECA, and robot-assisted surgery with laparoscopy. RESULTS: Some 1320 patients were included in an intention-to-treat analysis (laparoscopic ECA, 555; laparoscopic ICA, 356; robot-assisted ECA, 88; robot-assisted ICA, 321). No differences in the co-primary endpoint at 30 days after surgery were observed between cohorts (7.2 and 7.6 per cent in ECA and ICA groups respectively; 7.8 and 6.6 per cent in laparoscopic and robot-assisted groups). Lower overall complication rates were observed after ICA, specifically less ileus, and nausea and vomiting after robot-assisted procedures. CONCLUSION: No difference in the composite outcome of surgical wound infections and severe postoperative complications was found between intracorporeal versus extracorporeal anastomosis or laparoscopy versus robot-assisted surgery.


Assuntos
Neoplasias do Colo , Laparoscopia , Humanos , Estudos de Coortes , Estudos Prospectivos , Colectomia/métodos , Anastomose Cirúrgica/métodos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Laparoscopia/métodos , Resultado do Tratamento , Estudos Retrospectivos , Neoplasias do Colo/cirurgia
8.
JAMA Surg ; 158(6): 593-601, 2023 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-37074706

RESUMO

Importance: Both elective sigmoid resection and conservative treatment are options for patients with recurrent, complicated, or persistent painful diverticulitis; understanding outcomes following each can help inform decision-making. Objective: To compare outcomes of elective sigmoid resection and conservative treatment for patients with recurrent, complicated, or persistent painful diverticulitis at 2-year follow-up. Design, Setting, and Participants: This multicenter parallel open-label individually randomized clinical trial comparing elective sigmoid resection to conservative treatment in patients with recurrent, complicated, or persistent painful diverticulitis was carried out in 5 Finnish hospitals between September 2014 and October 2018. Follow-up up to 2 years is reported. Of 85 patients randomized and included, 75 and 70 were available for QOL outcomes at 1 year and 2 years, respectively, and 79 and 78 were available for the recurrence outcome at 1 year and 2 years, respectively. The present analysis was conducted from September 2015 to June 2022. Interventions: Laparoscopic elective sigmoid resection vs conservative treatment (patient education and fiber supplementation). Main Outcomes and Measures: Prespecified secondary outcomes included Gastrointestinal Quality of Life Index (GIQLI) score, complications, and recurrences within 2 years. Results: Ninety patients (28 male [31%]; mean [SD] age, 54.11 [11.9] years and 62 female [69%]; mean [SD] age, 57.13 [7.6] years) were randomized either to elective sigmoid resection or conservative treatment. After exclusions, 41 patients in the surgery group and 44 in the conservative group were included in the intention-to-treat analyses. Eight patients (18%) in the conservative treatment group underwent sigmoid resection within 2 years. The mean GIQLI score at 1 year was 9.51 points higher in the surgery group compared to the conservative group (mean [SD], 118.54 [17.95] vs 109.03 [19.32]; 95% CI, 0.83-18.18; P = .03), while the mean GIQLI score at 2 years was similar between the groups. Within 2 years, 25 of 41 patients in the conservative group (61%) had recurrent diverticulitis compared to 4 of 37 patients in the surgery group (11%). Four of 41 patients in the surgery group (10%) and 2 of 44 in the conservative group (5%) had major postoperative complications within 2 years. In per-protocol analyses, the mean (SD) GIQLI score was higher in the surgery group compared to the conservative treatment group by 11.27 points at 12 months (119.42 [17.98] vs 108.15 [19.28]; 95% CI, 2.24-20.29; P = .02) and 10.43 points at 24 months (117.24 [15.51] vs 106.82 [18.94]; 95% CI, 1.52-19.33; P = .02). Conclusions and Relevance: In this randomized clinical trial, elective sigmoid resection was effective in preventing recurrent diverticulitis and improved quality of life over conservative treatment within 2 years. Trial Registration: ClinicalTrials.gov Identifier: NCT02174926.


Assuntos
Diverticulite , Laparoscopia , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Qualidade de Vida , Tratamento Conservador , Resultado do Tratamento , Recidiva Local de Neoplasia/etiologia , Diverticulite/cirurgia , Laparoscopia/métodos
9.
Br J Cancer ; 128(12): 2218-2226, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37031328

RESUMO

BACKGROUND: Colorectal cancer (CRC) causes the second most cancer deaths worldwide, but the disease course varies according to tumour characteristics and immunological factors. Our objective was to examine the associations of tumour necrosis with tumour characteristics, immune cell infiltrates, serum cytokine concentrations, as well as prognosis in CRC. METHODS: Three independent CRC cohorts, including 1413 patients, were analysed. Associations of the areal percentage of tumour necrosis with clinicopathologic parameters, tumour infiltrating immune cells, cytokine concentrations in systemic and mesenteric vein blood, and survival were examined. RESULTS: Higher tumour necrosis percentage associated with shorter colorectal cancer-specific survival independent of tumour grade, T, N or M-class, mismatch repair status, BRAF status, and other possible confounding factors. In the largest cohort (N = 1100), the HR for high tumour necrosis percentage (≥40% vs. <3%) was 3.22 (95% CI 1.68-6.17, Ptrend < 0.0001). Tumour necrosis percentage positively correlated with peripheral serum levels of CXCL8, a proinflammatory chemokine, and negatively correlated with mesenteric serum levels of CXCL10 and mast cell densities in the invasive margin of the tumour. CONCLUSIONS: Our results support the value of tumour necrosis as a prognostic factor in colorectal cancer. CXCL8 may have a role in the systemic effects of tumour necrosis.


Assuntos
Neoplasias Colorretais , Humanos , Prognóstico , Neoplasias Colorretais/patologia , Necrose
10.
BMC Surg ; 23(1): 68, 2023 Mar 27.
Artigo em Inglês | MEDLINE | ID: mdl-36973782

RESUMO

BACKGROUND: Incisional hernia is a frequent complication after loop-ileostomy closure, rationalizing hernia prevention. Biological meshes have been widely used in contaminated surgical sites instead of synthetic meshes in fear of mesh related complications. However, previous studies on meshes does not support this practice. The aim of Preloop trial was to study the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. METHODS: The Preloop randomized, feasibility trial was conducted from April 2018 until November 2021 in four hospitals in Finland. The trial enrolled 102 patients with temporary loop-ileostomy after anterior resection for rectal cancer. The study patients were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene Macro™, Medtronic) (SM) or a biological mesh (Permacol™, Medtronic) (BM) to the retrorectus space at ileostomy closure. The primary end points were rate of surgical site infections (SSI) at 30-day follow-up and incisional hernia rate during 10 months' follow-up period. RESULTS: Of 102 patients randomized, 97 received the intended allocation. At 30-day follow-up, 94 (97%) patients were evaluated. In the SM group, 1/46 (2%) had SSI. Uneventful recovery was reported in 38/46 (86%) in SM group. In the BM group, 2/48 (4%) had SSI (p > 0.90) and in 43/48 (90%) uneventful recovery was reported. The mesh was removed from one patient in both groups (p > 0.90). CONCLUSIONS: Both a synthetic mesh and biological mesh were safe in terms of SSI after loop-ileostomy closure. Hernia prevention efficacy will be published after the study patients have completed the 10 months' follow-up.


Assuntos
Hérnia Incisional , Humanos , Hérnia Incisional/etiologia , Hérnia Incisional/prevenção & controle , Ileostomia/efeitos adversos , Telas Cirúrgicas/efeitos adversos , Estudos de Viabilidade , Hérnia/complicações , Infecção da Ferida Cirúrgica/complicações
11.
J Abdom Wall Surg ; 2: 11499, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38312418

RESUMO

Background: Hernia patches for umbilical hernia repair have gained popularity due to their short operation time and ease of use. However, up to 10% re-operation and 8% recurrence rates at 2-year follow-up have been published. This retrospective cohort study presents the long-term results of the hernia patch technique for umbilical hernia repair. Methods: All adult patients who underwent a primary umbilical hernia repair at Oulu University Hospital hernia surgery units during 2014-2018 were included in the study. The primary outcome measure was recurrence rate. Secondary outcomes were complications and re-operation rate. Results: A total of 619 elective primary umbilical hernia repairs were performed during 2014-2018. The major technique used was Ventralex™ ST hernia patch repair (79.0%, 488/619) for small hernias with a mean width of 1.8 (SD 0.79) cm. Most of the patches (84.7%, 414/488) were placed in the preperitoneal space. Hernia recurrence rate of patient operated on using Ventralex™ ST hernia patch was 2.5% (12/488) during a mean follow-up time of 68 (SD 16, 43-98) months. Re-operation rate for another reason than recurrence was 1.6% (8/488). Clavien-Dindo complications ≥3 occurred in 4.1% (20/488) of cases and surgical site infection rate was 3.3% (16/488). Conclusion: Umbilical hernia repair using a Ventralex™ ST hernia patch placed in preperitoneal space have acceptable results in terms of recurrence and re-operations in this cohort study.

12.
BMC Nutr ; 8(1): 89, 2022 Sep 02.
Artigo em Inglês | MEDLINE | ID: mdl-36050804

RESUMO

BACKGROUND: Colon cancer is one of the most common cancers in Finland and worldwide. Cancer-related malnutrition is a well-known risk factor for increased morbidity and mortality after surgery, and it is associated with complications and longer hospitalizations. There are no established recommendations on how to improve the nutritional status of colon cancer patients´ during the perioperative phase. Administration of simple oral nutritional supplements has been suggested to reduce complication rates, but evidence to support this practice is scarce. METHODS: The Peri-Nutri trial is a prospective, multicenter, randomized, controlled trial. Its primary endpoint is to evaluate whether perioperative oral nutritional support (ONS) decreases the number of complications during the 30-day follow-up after surgery. Secondary endpoints are to study the effect of ONS on quality of life after surgery, length of stay in institutional care, 90-day mortality rate, five-year disease-free survival and overall survival. The patients with a Nutritional risk screening 2002 (NRS-2002) questionnaire result between 2 and 5 (≥ 3 are classified at risk of malnutrition) will be randomized (1:1 ratio) into either the intervention or control group. The intervention group will receive preoperative ONS two weeks before the operation, and nutritional support will continue 10 days after the operation. The control group will not receive ONS. A total of 318 patients will be randomized into two groups and patients are followed five years. DISCUSSION: Peri-Nutri study evaluate the impact of ONS to short-term and long-term postoperative morbidity and mortality rates of colon cancer patients undergoing curative surgery. If ONS will decrease patients´ morbidity and mortality, that has a huge impact on patients´ quality of life and also to financial cost. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03863236 , Registered 25 February 2019.

13.
BMC Surg ; 22(1): 296, 2022 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-35907824

RESUMO

BACKGROUND: Perineal wound complications are common after abdominoperineal resection (APR) for rectal adenocarcinoma. Delayed wound healing may postpone postoperative adjuvant therapy and, therefore, lead to a worse survival rate. Negative-pressure wound therapy (NPWT) has been suggested to improve healing, but research on this subject is limited. METHODS: The aim of this study was to assess whether NPWT reduces surgical site infections (SSI) after APR for rectal adenocarcinoma when the closure is performed with a biological mesh and a local flap. A total of 21 consecutive patients had an NPWT device (Avelle, Convatec™) applied to the perineal wound. The study patients were compared to a historical cohort in a case-control setting in relation to age, body mass index, tumor stage, and length of neoadjuvant radiotherapy. The primary outcome was the surgical site infection rate. The secondary outcomes were the wound complication rate, the severity of wound complications measured by the Clavien-Dindo classification, length of hospital stay, and surgical revision rate. RESULTS: The SSI rate was 33% (7/21) in the NPWT group and 48% (10/21) in the control group, p = 0.55. The overall wound complication rate was 62% (13/21) in NPWT patients and 67% (14/21) in the control group, p > 0.90. The length of hospital stay was 15 days in the NPWT group and 13 in the control group, p = 0.34. The wound severity according to the Clavien-Dindo classification was 3b in 29% (6/21) of the NPWT group and in 38% (8/21) of the control group. A surgical revision had to be performed in 29% (6/21) of the cases in the NPWT group and 38% (8/21) in the control group, p = 0.73. CONCLUSION: NPWT did not statistically decrease surgical site infections or reduce wound complication severity in perineal wounds after APR in this case-control study. The results may be explained by technical difficulties in applying NPWT in the perineum, especially in female patients. NPWT devices should be further developed to suit the perineal anatomy before their full effect can be assessed. Trial registration The study was registered as a prospective registry study (266/2018, registered 15th of November 2018).


Assuntos
Adenocarcinoma , Tratamento de Ferimentos com Pressão Negativa , Protectomia , Neoplasias Retais , Adenocarcinoma/complicações , Adenocarcinoma/cirurgia , Estudos de Casos e Controles , Feminino , Humanos , Tratamento de Ferimentos com Pressão Negativa/efeitos adversos , Períneo/cirurgia , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Protectomia/métodos , Neoplasias Retais/patologia , Infecção da Ferida Cirúrgica/complicações , Infecção da Ferida Cirúrgica/epidemiologia
14.
BMJ Open ; 12(7): e063572, 2022 07 18.
Artigo em Inglês | MEDLINE | ID: mdl-35851028

RESUMO

INTRODUCTION: Endometriosis is a common gynaecological disease affecting around 10% of fertile-aged women, causing severe pain symptoms. Deep endometriosis is defined as endometriotic implants that infiltrate the underlying organs more than 5 mm in depth. Surgery for deep endometriosis requires advanced multidisciplinary surgical technique, often in very difficult surgical conditions, with increased risks of complications. Robotic surgery offers a high-definition three-dimensional view and articulating instruments that may allow more precise dissection than conventional laparoscopy in the pelvic area. The superiority of robotic surgery has not, however, been provedin randomised controlled studies, and there is a lack of long-term outcome data. Advanced endometriosis surgery offers an excellent platform to study the feasibility and long-term outcomes of robotic surgery compared with conventional laparoscopy. METHODS AND ANALYSIS: ROBEndo is a prospective, randomised, controlled clinical trial in a single-centre setting. Patients with deep endometriosis verified by MRI needing surgery at Oulu University Hospital (Oulu, Finland) will be considered eligible. 70 patients will be allocated 1:1 to receive either robotic-assisted or conventional laparoscopic surgery in two strata: radical surgery (with the removal of the uterus and adnexae) and gynaecological organ-sparing surgery. The primary outcome will be the surgical outcome as regards to pain symptoms measured on numeric rating scale (NRS) questionnaires at 24 hours and 6, 12 and 24 months postoperatively. As secondary outcomes, intraoperative measures, enhanced recovery after surgery factors, complications, cost and long-term quality of life measured with Endometriosis Health Profile-30 (EHP-30), Female Sexual Function Index (FSFI) and 15-dimensional (15D) questionnaires will be compared. ETHICS AND DISSEMINATION: This study has been approved by the Northern Ostrobothnian Hospital District Ethical Committee at Oulu University Hospital (212/2021). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be published in peer-reviewed international journals. TRIAL REGISTRATION NUMBER: NCT05179109.


Assuntos
Endometriose , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Idoso , Endometriose/complicações , Feminino , Humanos , Laparoscopia/métodos , Dor/complicações , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
15.
Scand J Surg ; 111(2): 14574969221107276, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35748305

RESUMO

PURPOSE: The aim of this systematic review was to evaluate the risk of parastomal (PSH) and incisional hernias (IH) after emergency surgery for Hinchey III-IV diverticulitis, with comparison between the Hartmann procedure and other surgical techniques. METHODS: The Cochrane Library, Embase, PubMed (MEDLINE), Web of Science and Scopus databases were systematically searched. The primary endpoint was parastomal hernia incidence. The secondary endpoint was incisional hernia incidence. RESULTS: Five studies (four randomized controlled trials and one retrospective cohort) with a total of 699 patients were eligible for inclusion. The PSH rate was 15%-46% for Hartmann procedure, 0%-85% for primary anastomosis, 4% for resection, and 2% for laparoscopic lavage. The IH rates were 5%-38% for Hartmann procedure, 5%-27% for primary anastomosis, 9%-12% for primary resection, and 3%-11% for laparoscopic lavage. CONCLUSIONS: Both the parastomal and incisional hernia incidences are poorly evaluated and reported, and varied greatly between the studies.


Assuntos
Diverticulite , Hérnia Incisional , Laparoscopia , Anastomose Cirúrgica/efeitos adversos , Diverticulite/complicações , Diverticulite/cirurgia , Humanos , Incidência , Hérnia Incisional/epidemiologia , Hérnia Incisional/etiologia , Hérnia Incisional/cirurgia , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos
16.
BJS Open ; 6(3)2022 05 02.
Artigo em Inglês | MEDLINE | ID: mdl-35748378

RESUMO

BACKGROUND: Transversus abdominis release (TAR) is a surgical technique used in the treatment of complex ventral hernias. The aim of this study was to compare outcomes of open (oTAR) versus robotic-assisted (rTAR) posterior component separation by TAR. METHODS: Consecutive patients at two European hernia centres who underwent bilateral TAR were included. The primary endpoint was the duration of postoperative hospital stay. RESULTS: Data from 90 rTAR and 79 oTAR operations were evaluated. Patient demographics were similar between groups in terms of age, sex, BMI, and co-morbidities. There were more smokers, and hernias were larger in the oTAR group (width 8.7 cm versus 10.0 cm; P = 0.031, length 11.6 cm versus 14.1 cm; P = 0.005). Duration of postoperative hospital stay was significantly shorter in the rTAR group (3.4 days versus 6.9 days; P < 0.001). Short-term serious complications (Clavien-Dindo grade III and above) were more frequent (20.3 per cent versus 7.8 per cent; P = 0.018), and there were more surgical site infections (12.7 per cent versus 3.3 per cent; P = 0.010) in the oTAR group. During a median follow-up of 19 months in the rTAR group and 43 months in the oTAR group, reoperation (4.4 per cent versus 8.9 per cent; P = 0.245), and recurrence rates (5.6 per cent versus 5.1 per cent; P > 0.009) were similar. CONCLUSION: Patients with ventral incisional hernias who undergo bilateral rTAR had significantly shorter postoperative hospital stays and fewer short-term complications compared with patients undergoing bilateral oTAR.


Assuntos
Parede Abdominal , Hérnia Ventral , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Músculos Abdominais/cirurgia , Parede Abdominal/cirurgia , Hérnia Ventral/cirurgia , Herniorrafia/efeitos adversos , Herniorrafia/métodos , Humanos , Laparoscopia/efeitos adversos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos
17.
J Clin Med ; 11(9)2022 May 09.
Artigo em Inglês | MEDLINE | ID: mdl-35566781

RESUMO

Cancer patients commonly present sarcopenia, myosteatosis, and systemic inflammation, which are risk factors of poor survival. In this study, sarcopenia and myosteatosis were defined from preoperative body computed tomography scans of 222 colorectal cancer (CRC) patients and analyzed in relation to tumor and patient characteristics, markers of systemic inflammation (modified Glasgow prognostic score (mGPS), neutrophil−lymphocyte ratio (NLR), serum levels of C-reactive protein (CRP), albumin, and 13 cytokines, and survival. Of the systemic inflammation markers, sarcopenia and/or myosteatosis associated with elevated NLR (p = 0.005) and low albumin levels (≤35 g/L) (p = 0.018), but not with mGPS or serum cytokine levels. In addition, myosteatosis was associated with a proximal tumor location (p = 0.039), serrated tumor subtype (p < 0.001), and severe comorbidities (p = 0.004). Multivariable analyses revealed that severe comorbidities and serrated histology were independent predictors of myosteatosis, and older age and elevated NLR were independent indicators of sarcopenia. Myosteatosis associated with shorter overall survival in univariable analysis (HR 1.959, 95% CI 1.24−3.10, p = 0.004) but not in multivariable analysis (p = 0.075). We conclude that sarcopenia and myosteatosis were associated with inflammatory marker NLR, but not with mGPS. Moreover, patients with serrated CRC may have an increased risk of myosteatosis. Myosteatosis or sarcopenia were not independent predictors of patient survival.

18.
Br J Surg ; 109(6): 503-509, 2022 05 16.
Artigo em Inglês | MEDLINE | ID: mdl-35576384

RESUMO

BACKGROUND: Non-operative management of uncomplicated acute appendicitis is an option, but omission of antibiotics from the regimen has not been tested. METHODS: A double-blind, placebo-controlled, superiority RCT in adults with CT-confirmed uncomplicated acute appendicitis was designed to compare placebo with antibiotics (intravenous ertapenem followed by oral levofloxacin and metronidazole). The primary endpoint was treatment success (resolution resulting in discharge without appendicectomy within 10 days); secondary outcomes included pain scores, complications, hospital stay, and return to work. RESULTS: From May 2017 to September 2020, 72 patients with a mean(s.d.) age of 37.5 (11.1) years were recruited at five hospitals. Six were excluded after randomization (5 early consent withdrawals, 1 randomization protocol violation), 35 were assigned to receive antibiotics, and 31 to receive placebo. Enrolment challenges (including hospital pharmacy resources in an acute-care surgery setting) meant that only the lowest sample size of three predefined scenarios was achieved. The 10-day treatment success rate was 87 (95 per cent c.i. 75 to 99) per cent for placebo and 97 (92 to 100) per cent for antibiotics. This clinical difference of 10 (90 per cent c.i. -0.9 to 21) per cent was not statistically different for the primary outcome (1-sided P = 0.142), and secondary outcomes were similar. CONCLUSION: The lack of antibiotic superiority statistically suggests that a non-inferiority trial against placebo is warranted in adults with CT-confirmed mild appendicitis. Registration number: EudraCT 2015-003634-26 (https://eudract.ema.europa.eu/eudract-web/index.faces), NCT03234296 (http://www.clinicaltrials.gov).


Appendicitis was the most common reason for emergency surgery, but we now know that mild and severe acute appendicitis are two different diseases. Severe appendicitis still necessitates removal of the appendix but antibiotics alone are an option for mild disease. This small study found that most cases of mild appendicitis to resolve even without antibiotics. Larger studies (more patients) would be needed to show that omitting antibiotics is safe and no worse than antibiotic therapy for milder acute appendicitis.


Assuntos
Apendicite , Doença Aguda , Adulto , Antibacterianos/uso terapêutico , Apendicectomia , Apendicite/diagnóstico por imagem , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Ertapenem/uso terapêutico , Humanos , Tomografia Computadorizada por Raios X , Resultado do Tratamento
19.
Int J Colorectal Dis ; 37(5): 1173-1180, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35474547

RESUMO

PURPOSE: Recent studies have reported alarming appendiceal tumor rates associated with complicated acute appendicitis, especially in patients presenting with a periappendicular abscess. However, the data on histology of appendiceal tumors among acute appendicitis patients is limited, especially in patient cohorts differentiating between uncomplicated and complicated acute appendicitis. We have previously reported the association of increased appendiceal tumor prevalence with complicated acute appendicitis in this population-based study. The objective of this secondary analysis was to evaluate the association of both appendicitis severity and patient age with appendiceal tumor histology. METHODS: This nationwide population-based registry study (The Finnish Cancer Registry) was conducted from 2007 to 2013. All appendiceal tumors (n = 840) and available medical reports (n = 504) of these patients at eight study hospitals were previously evaluated, identifying altogether 250 patients with both acute appendicitis and appendiceal tumor. RESULTS: The severity of acute appendicitis was significantly associated with more malignant tumor histology. The risk of adenocarcinoma or pseudomyxoma was significantly higher among patients with periappendicular abscess (OR 15.05, CI 95% 6.98-32.49, p < 0.001) and patients presenting with perforated acute appendicitis (OR 4.09, CI 95% 1.69-9.90, p = 0.0018) compared to patients with uncomplicated acute appendicitis. Similarly, patient age over 40 years was significantly associated with the risk of adenocarcinoma and pseudomyxoma (OR 26.46, Cl 95% 7.95-88.09, p < 0.001). Patient sex was not associated with a more malignant appendiceal tumor histology (p = 0.67). CONCLUSION: More malignant appendiceal tumor histology of adenocarcinoma or pseudomyxoma was significantly associated with patient age over 40 years and complicated acute appendicitis, especially periappendicular abscess.


Assuntos
Adenocarcinoma , Neoplasias do Apêndice , Apendicite , Abscesso/complicações , Abscesso/epidemiologia , Doença Aguda , Adenocarcinoma/complicações , Adulto , Apendicectomia/efeitos adversos , Neoplasias do Apêndice/complicações , Neoplasias do Apêndice/epidemiologia , Neoplasias do Apêndice/patologia , Apendicite/complicações , Apendicite/epidemiologia , Apendicite/patologia , Humanos
20.
Colorectal Dis ; 24(6): 747-753, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35119795

RESUMO

AIM: The aim of this work was to study the technical success and diagnostic capability of magnetic resonance defaecography (MRD) compared with video defaecography (VD). METHOD: Sixty four women with defaecation disorders underwent both MRD and x-ray VD over 1 year. The assessment by two radiologists in consensus was retrospective and blinded. The technical success of straining and evacuation was evaluated subjectively. The presence of enterocele, intussusception, rectocele and dyssynergic defaecation was analysed according to established criteria, with VD as the standard of reference. RESULTS: It was found that 62/64 (96.9%) VD studies were technically fully diagnostic compared with 29/64 (45.3%) for MRD. The number of partially diagnostic studies was 1/64 (1.6%) for VD versus 21/64 (32.8%) for MRD, with 1/64 (1.6%) (VD) and 14/64 (21.9%) (MRD) being nondiagnostic. Thirty enteroceles were observed by VD compared with seven in MRD with moderate agreement (κ = 0.41). Altogether 53 intussusceptions were observed by VD compared with 27 by MRD with poor agreement (κ = -0.10 and κ = 0.02 in recto-rectal and recto-anal intussusception, respectively). Moderate agreement (κ = 0.47) was observed in diagnosing rectocele, with 47 cases by VD and 29 by MRD. Dyssynergic defaecation was observed in three patients by VD and in 11 patients by MRD, with slight agreement (κ = 0.14). CONCLUSION: The technical success and diagnostic capabilities of VD are better than those of MRD. VD remains the method of choice in the imaging of defaecation disorders.


Assuntos
Defecografia , Intussuscepção , Constipação Intestinal/diagnóstico por imagem , Defecação , Defecografia/métodos , Feminino , Hérnia , Humanos , Intussuscepção/complicações , Intussuscepção/diagnóstico por imagem , Imageamento por Ressonância Magnética/métodos , Espectroscopia de Ressonância Magnética , Retocele/complicações , Retocele/diagnóstico por imagem , Estudos Retrospectivos , Raios X
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