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1.
Br J Surg ; 111(1)2024 Jan 03.
Artículo en Inglés | MEDLINE | ID: mdl-37944025

RESUMEN

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).


Asunto(s)
Hernia Incisional , Humanos , Ileostomía/efectos adversos , Hernia Incisional/etiología , Hernia Incisional/prevención & control , Hernia Incisional/epidemiología , Calidad de Vida , Mallas Quirúrgicas/efectos adversos , Infección de la Herida Quirúrgica/etiología , Infección de la Herida Quirúrgica/prevención & control
2.
Br J Cancer ; 128(12): 2218-2226, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37031328

RESUMEN

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.


Asunto(s)
Neoplasias Colorrectales , Humanos , Pronóstico , Neoplasias Colorrectales/patología , Necrosis
3.
Br J Surg ; 110(9): 1153-1160, 2023 08 11.
Artículo en Inglés | MEDLINE | ID: mdl-37289913

RESUMEN

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.


Asunto(s)
Neoplasias del Colon , Laparoscopía , Humanos , Estudios de Cohortes , Estudios Prospectivos , Colectomía/métodos , Anastomosis Quirúrgica/métodos , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/etiología , Laparoscopía/métodos , Resultado del Tratamiento , Estudios Retrospectivos , Neoplasias del Colon/cirugía
4.
Acta Obstet Gynecol Scand ; 102(12): 1634-1642, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-37814355

RESUMEN

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.


Asunto(s)
Dolor Crónico , Terapia por Estimulación Eléctrica , Endometriosis , Humanos , Femenino , Endometriosis/complicaciones , Endometriosis/terapia , Estudios Prospectivos , Calidad de Vida , Proyectos Piloto , Dolor Pélvico/etiología , Dolor Pélvico/terapia , Resultado del Tratamiento , Dolor Crónico/etiología , Dolor Crónico/terapia
5.
BMC Surg ; 23(1): 68, 2023 Mar 27.
Artículo en Inglés | MEDLINE | ID: mdl-36973782

RESUMEN

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.


Asunto(s)
Hernia Incisional , Humanos , Hernia Incisional/etiología , Hernia Incisional/prevención & control , Ileostomía/efectos adversos , Mallas Quirúrgicas/efectos adversos , Estudios de Factibilidad , Hernia/complicaciones , Infección de la Herida Quirúrgica/complicaciones
6.
Br J Surg ; 109(6): 503-509, 2022 05 16.
Artículo en Inglés | MEDLINE | ID: mdl-35576384

RESUMEN

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.


Asunto(s)
Apendicitis , Enfermedad Aguda , Adulto , Antibacterianos/uso terapéutico , Apendicectomía , Apendicitis/diagnóstico por imagen , Apendicitis/tratamiento farmacológico , Apendicitis/cirugía , Ertapenem/uso terapéutico , Humanos , Tomografía Computarizada por Rayos X , Resultado del Tratamiento
7.
Int J Colorectal Dis ; 37(5): 1173-1180, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-35474547

RESUMEN

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.


Asunto(s)
Adenocarcinoma , Neoplasias del Apéndice , Apendicitis , Absceso/complicaciones , Absceso/epidemiología , Enfermedad Aguda , Adenocarcinoma/complicaciones , Adulto , Apendicectomía/efectos adversos , Neoplasias del Apéndice/complicaciones , Neoplasias del Apéndice/epidemiología , Neoplasias del Apéndice/patología , Apendicitis/complicaciones , Apendicitis/epidemiología , Apendicitis/patología , Humanos
8.
Colorectal Dis ; 24(6): 747-753, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-35119795

RESUMEN

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.


Asunto(s)
Defecografía , Intususcepción , Estreñimiento/diagnóstico por imagen , Defecación , Defecografía/métodos , Femenino , Hernia , Humanos , Intususcepción/complicaciones , Intususcepción/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Espectroscopía de Resonancia Magnética , Rectocele/complicaciones , Rectocele/diagnóstico por imagen , Estudios Retrospectivos , Rayos X
9.
BMC Surg ; 22(1): 296, 2022 Jul 30.
Artículo en Inglés | MEDLINE | ID: mdl-35907824

RESUMEN

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).


Asunto(s)
Adenocarcinoma , Terapia de Presión Negativa para Heridas , Proctectomía , Neoplasias del Recto , Adenocarcinoma/complicaciones , Adenocarcinoma/cirugía , Estudios de Casos y Controles , Femenino , Humanos , Terapia de Presión Negativa para Heridas/efectos adversos , Perineo/cirugía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Proctectomía/métodos , Neoplasias del Recto/patología , Infección de la Herida Quirúrgica/complicaciones , Infección de la Herida Quirúrgica/epidemiología
10.
Colorectal Dis ; 23(9): 2228-2285, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34060715

RESUMEN

This is a comprehensive and rigorous review of currently available data on the use of mesh in the pelvis in colorectal surgery. This guideline outlines the limitations of available data and the challenges of interpretation, followed by best possible recommendations.


Asunto(s)
Cirugía Colorrectal , Procedimientos Quirúrgicos del Sistema Digestivo , Humanos , Pelvis/cirugía , Prótesis e Implantes , Mallas Quirúrgicas
11.
World J Surg ; 45(6): 1742-1749, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33560501

RESUMEN

BACKGROUND: Parastomal hernia repair is a complex surgical procedure with high recurrence and complication rates. This retrospective nationwide cohort study presents the results of different parastomal hernia repair techniques in Finland. METHODS: All patients who underwent a primary end ostomy parastomal hernia repair in the nine participating hospitals during 2007-2017 were included in the study. The primary outcome measure was recurrence rate. Secondary outcomes were complications and re-operation rate. RESULTS: In total, 235 primary elective parastomal hernia repairs were performed in five university hospitals and four central hospitals in Finland during 2007-2017. The major techniques used were the Sugarbaker (38.8%), keyhole (16.3%), and sandwich techniques (15.4%). In addition, a specific intra-abdominal keyhole technique with a funnel-shaped mesh was utilized in 8.3% of the techniques; other parastomal hernia repair techniques were used in 21.3% of the cases. The median follow-up time was 39.0 months (0-146, SD 35.3). The recurrence rates after the keyhole, Sugarbaker, sandwich, specific funnel-shaped mesh, and other techniques were 35.9%, 21.5%, 13.5%, 15%, and 35.3%, respectively. The overall re-operation rate was 20.4%, while complications occurred in 26.3% of patients. CONCLUSION: The recurrence rate after parastomal hernia repair is unacceptable in this nationwide cohort study. As PSH repair volumes are low, further multinational, randomized controlled trials and hernia registry data are needed to improve the results.


Asunto(s)
Hernia Ventral , Hernia Incisional , Estomas Quirúrgicos , Estudios de Cohortes , Finlandia/epidemiología , Estudios de Seguimiento , Hernia Ventral/epidemiología , Hernia Ventral/cirugía , Herniorrafia , Humanos , Hernia Incisional/epidemiología , Hernia Incisional/etiología , Hernia Incisional/cirugía , Recurrencia Local de Neoplasia , Recurrencia , Estudios Retrospectivos , Mallas Quirúrgicas , Estomas Quirúrgicos/efectos adversos
12.
BMC Surg ; 21(1): 231, 2021 May 03.
Artículo en Inglés | MEDLINE | ID: mdl-33941154

RESUMEN

BACKGROUND: Previous research on parastomal hernia repair following ileal conduit urinary diversion is limited. This nationwide cohort study aims to present the results of keyhole and Sugarbaker techniques in parastomal hernia repair in the setting of ileal conduit urinary diversion. METHOD: All patients in this cohort underwent primary elective parastomal hernia repair following ileal conduit urinary diversion in four university hospitals and one central hospital in Finland in 2007-2017. Retrospective clinical data were collected from patient registries to compare keyhole and Sugarbaker parastomal hernia repair techniques. The primary outcome was parastomal hernia recurrence during the follow-up from primary surgery to the last confirmed follow-up date of the patient. The secondary outcomes were reoperations during the follow-up and complication rate at 30 days' follow-up. RESULTS: The results of 28 hernioplasties were evaluated. The overall parastomal hernia recurrence rate was 18%, the re-operation rate was 14%, and the complication rate was 14% during the median follow-up time of 30 (21-64) months. Recurrence rates were 22% (4/18) after keyhole repair and 10% (1/10) after Sugarbaker repair. Re-operation rates referred to keyhole repair were 22% and Sugarbaker repair 0% during follow-up. The majority of reoperations were indicated by recurrence. Complication rates were 17% after keyhole and 10% after Sugarbaker repair during the 30 days' follow-up. CONCLUSION: The results of parastomal hernia repair in the setting of ileal conduits are below optimal in this nationwide cohort comparing keyhole to Sugarbaker repair in elective parastomal hernia repair. Nonetheless, the Sugarbaker technique should be further studied to confirm the encouraging results of this cohort in terms of recurrence.


Asunto(s)
Hernia Ventral , Estomas Quirúrgicos , Derivación Urinaria , Estudios de Cohortes , Finlandia/epidemiología , Hernia Ventral/cirugía , Herniorrafia , Humanos , Recurrencia Local de Neoplasia , Estudios Retrospectivos , Mallas Quirúrgicas , Estomas Quirúrgicos/efectos adversos , Derivación Urinaria/efectos adversos
13.
JAMA ; 325(4): 353-362, 2021 01 26.
Artículo en Inglés | MEDLINE | ID: mdl-33427870

RESUMEN

Importance: Antibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known. Objective: To compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography-confirmed uncomplicated acute appendicitis. Design, Setting, and Participants: The Appendicitis Acuta (APPAC) II multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. A total of 599 patients aged 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis were enrolled in the trial. The last date of follow-up was November 29, 2019. Interventions: Patients randomized to receive oral monotherapy (n = 295) received oral moxifloxacin (400 mg/d) for 7 days. Patients randomized to receive intravenous antibiotics followed by oral antibiotics (n = 288) received intravenous ertapenem (1 g/d) for 2 days followed by 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 (≥65%) for both groups, defined as discharge from hospital without surgery and no recurrent appendicitis during 1-year follow-up, and to determine whether oral antibiotics alone were noninferior to intravenous and oral antibiotics, with a margin of 6% for difference. Results: Among 599 patients who were randomized (mean [SD] age, 36 [12] years; 263 [44%] women), 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at 1 year was 70.2% (1-sided 95% CI, 65.8% to ∞) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to ∞) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to ∞]; P = .26 for noninferiority), with the confidence limit exceeding the noninferiority margin. Conclusion and Relevance: Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961; EudraCT Identifier: 2015-003633-10.


Asunto(s)
Antibacterianos/uso terapéutico , Apendicitis/tratamiento farmacológico , Enfermedad Aguda , Administración Intravenosa , Administración Oral , Adulto , Antibacterianos/administración & dosificación , Antibacterianos/efectos adversos , Apendicectomía , Apendicitis/diagnóstico por imagen , Apendicitis/cirugía , Quimioterapia Combinada , Ertapenem/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Levofloxacino/uso terapéutico , Masculino , Metronidazol/uso terapéutico , Persona de Mediana Edad , Moxifloxacino/uso terapéutico , Tomografía Computarizada por Rayos X , Adulto Joven
14.
Dis Colon Rectum ; 63(5): 678-684, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-32032196

RESUMEN

BACKGROUND: Parastomal hernias are common with permanent colostomies and prone to complications. The short-term results of trials of parastomal hernia prevention are widely published, but long-term results are scarce. OBJECTIVE: The aim of the study is to detect the long-term effects and safety of preventive intra-abdominal parastomal mesh. DESIGN: This is a long-term follow-up of a previous prospective randomized, controlled multicenter trial. SETTINGS: This study was conducted at 2 university hospitals and 3 central hospitals in Finland. PATIENTS: Patients who had a laparoscopic abdominoperineal resection for rectal cancer between 2010 and 2013 were included in the study and invited for a follow-up visit. MAIN OUTCOME MEASURES: The primary outcomes measured were clinical and radiological parastomal hernias. RESULTS: Twenty subjects in the mesh group and 15 in the control group attended the follow-up visit with a median follow-up period of 65 (25th-75th percentiles, 49-91) months. A clinically detectable parastomal hernia was present in 4 of 20 (20.0%) and 5 of 15 (33.3%) subjects in the mesh and control groups (p = 0.45). A radiological parastomal hernia was present in 9 of 19 (45.0%) subjects in the mesh group and 7 of 12 (58.3%) subjects in the control group (p = 0.72). However, when all subjects (n = 70, 1:1) who attended the 12-month follow-up were screened for long-term results according to register data, 9 of 35 (25.9%) subjects in the mesh group and 16 of 35 (45.6%) subjects in control group were diagnosed with a parastomal hernia during the follow-up period (p = 0.10). In addition, only 1 of 35 (2.7%) subjects in the mesh group but 6 of 35 (17.1%) subjects in the control group underwent a parastomal hernia operation during the long-term follow-up (p = 0.030). LIMITATIONS: The study is limited by the small number of patients. CONCLUSION: Prophylactic intra-abdominal keyhole mesh did not decrease the rate of clinically detectable hernias but reduced the need for the surgical repair of parastomal hernias. Further trials are needed to identify a more efficient method to prevent parastomal hernias. See Video Abstract at http://links.lww.com/DCR/B171. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov. Identifier: NCT02368873. ESTUDIO PROSPECTIVO ALEATORIZADO SOBRE EL USO DE MALLA PROTÉSICA PARA PREVENIR UNA HERNIA PARAESTOMAL EN UNA COLOSTOMÍA PERMANENTE: RESULTADOS DE UN SEGUIMIENTO A LARGO PLAZO: PREVENCIÓN DE HERNIA PARAESTOMAL, NEOPLASIA COLORRECTAL/ANAL: Las hernias paraestomales son comunes con colostomías permanentes y son propensas a complicaciones. Los resultados a corto plazo de los ensayos sobre la prevención de la hernia parastomal se publican ampliamente, pero los resultados a largo plazo son escasos.El objetivo del estudio es detectar los efectos a largo plazo y la seguridad de la malla parastomal intraabdominal preventiva.Este es un seguimiento a largo plazo de un estudio aleatorizado prospectivo, controlado y multicentrico previo.Este estudio se realizó en dos hospitales universitarios y tres hospitales centrales en Finlandia.Los pacientes que se sometieron a una resección abdominoperineal laparoscópica por cáncer de recto 2010-2013 fueron incluidos en el estudio e invitados a una visita de seguimiento.Hernias parastomales clínicas y radiológicas.Veinte sujetos en el grupo de malla y 15 en el grupo control asistieron a la visita de seguimiento con una mediana de seguimiento de 65 meses (25-75 ° percentil 49-91). Una hernia paraestomal clínicamente detectable estuvo presente en 4/20 (20.0%) y 5/15 (33.3%) en los grupos de malla y control, respectivamente (p = 0.45). Una hernia parastomal radiológica estuvo presente en 9/19 (45.0%) en el grupo de malla y 7/12 (58.3%) en el grupo de control (p = 0.72). Sin embargo, cuando todos los sujetos (n = 70, 1: 1) que asistieron a los 12 meses de seguimiento fueron evaluados para obtener resultados a largo plazo de acuerdo con los datos del registro, 9/35 (25.9%) sujetos en el grupo de malla y 16/35 (45,6%) sujetos en el grupo control fueron diagnosticados con una hernia paraestomal durante el período de seguimiento (p = 0,10). Además, solo 1/35 (2.7%) en el grupo de malla pero 6/35 (17.1%) en el grupo control se sometieron a una operación de hernia paraestomal durante el seguimiento a largo plazo (p = 0.030).El estudio está limitado por un pequeño número de pacientes.La malla intra-abdominal profiláctica en ojo de cerradura no disminuyó la tasa de hernias clínicamente detectables, pero redujo la necesidad de la reparación quirúrgica de las hernias paraestomales. Se necesitan ensayos adicionales para identificar un método más eficiente para prevenir las hernias parastomales. Vea el resumen del video en http://links.lww.com/DCR/B171. (Traducción-Dr. Gonzalo Hagerman).NCT02368873.


Asunto(s)
Colostomía/efectos adversos , Hernia Incisional/prevención & control , Proctectomía/efectos adversos , Neoplasias del Recto/cirugía , Mallas Quirúrgicas , Estomas Quirúrgicos/efectos adversos , Anciano , Femenino , Finlandia , Estudios de Seguimiento , Humanos , Laparoscopía/efectos adversos , Masculino , Persona de Mediana Edad , Estudios Prospectivos
15.
Int J Colorectal Dis ; 35(5): 971-972, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-32125521

RESUMEN

The authors regrets that a typo error found on their published paper. The correction are as follows.

16.
Surg Endosc ; 34(1): 88-95, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-30941550

RESUMEN

PURPOSE: Laparoscopic incisional ventral hernia repair (LIVHR) is often followed by seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence, chronic pain and poor quality of life (QoL). We aimed to evaluate whether LIVHR combined with defect closure (hybrid) follows as a diminished seroma formation and thereby has a lower rate of hernia recurrence and chronic pain compared to standard LIVHR. METHODS: This study is a multicentre randomised controlled clinical trial. From November 2012 to May 2015, 193 patients undergoing LIVHR for primary incisional hernia with fascial defect size from 2 to 7 cm were recruited in 11 Finnish hospitals. Patients were randomised to either a laparoscopic (LG) or a hybrid (HG) repair group. The main outcome measure was hernia recurrence, evaluated clinically and radiologically at a 1-year follow-up visit. At the same time, chronic pain scores and QoL were also measured. RESULTS: At the 1-year-control visit, we found no difference in hernia recurrence between the study groups. Altogether, 11 recurrent hernias were found in ultrasound examination, producing a recurrence rate of 6.4%. Of these recurrences, 6 (6.7%) were in the LG group and 5 (6.1%) were in the HG group (p > 0.90). The visual analogue scores for pain were low in both groups; the mean visual analogue scale (VAS) was 1.5 in LG and 1.4 in HG (p = 0.50). QoL improved significantly comparing preoperative status to 1 year after operation in both groups since the bodily pain score increased by 7.8 points (p < 0.001) and physical functioning by 4.3 points (p = 0.014). CONCLUSION: Long-term follow-up is needed to demonstrate the potential advantage of a hybrid operation with fascial defect closure. Both techniques had low hernia recurrence rates 1 year after operation. LIVHR reduces chronic pain and physical impairment and improves QoL. TRIAL REGISTRY: Clinical trial number NCT02542085.


Asunto(s)
Técnicas de Cierre de Herida Abdominal/instrumentación , Hernia Ventral/cirugía , Herniorrafia , Hernia Incisional/cirugía , Laparoscopía/métodos , Complicaciones Posoperatorias/prevención & control , Calidad de Vida , Seroma , Mallas Quirúrgicas , Femenino , Herniorrafia/efectos adversos , Herniorrafia/instrumentación , Herniorrafia/métodos , Humanos , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Complicaciones Posoperatorias/psicología , Prevención Secundaria , Seroma/etiología , Seroma/prevención & control , Seroma/psicología
17.
BMC Surg ; 20(1): 151, 2020 Jul 13.
Artículo en Inglés | MEDLINE | ID: mdl-32660467

RESUMEN

BACKGROUND: Right colectomy is the standard surgical treatment for tumors in the right colon and surgical complications are reduced with minimally-invasive laparoscopy compared with open surgery, with potential further benefits achieved with robotic assistance. The anastomotic technique used can also have an impact on patient outcomes. However, there are no large, prospective studies that have compared all techniques. METHODS/DESIGN: MIRCAST is the Minimally-Invasive Right Colectomy Anastomosis Study that will compare laparoscopy with robot-assisted surgery, using either intracorporeal or extracorporeal anastomosis, in a large prospective, observational, multicenter, parallel, four-cohort study in patients with a benign or malignant, non-metastatic tumor of the right colon. Over 2 years of follow-up, the study will prospectively evaluate peri- and postoperative complications, postoperative recovery, hospital stay, and mid-term results including survival, local recurrence, metastases rate, and conversion rate. The primary composite endpoint will be the efficacy of the surgical method regarding surgical wound infections and postoperative complications (Clavien-Dindo grade III-IV complications at 30 days post-surgery). Secondary endpoints include long-term oncologic results, conversion rate, operative time, length of stay, and quality of life. DISCUSSION: This will be the first large, international study to prospectively evaluate the use of minimally-invasive laparoscopy or robot-assisted surgery during right hemicolectomy and to control for the impact of the anastomotic technique. The research will contribute to current knowledge regarding the medical care of patients with malignant or benign tumors of the right colon, and enable physicians to determine which technique may be the most appropriate for their patients. TRIAL REGISTRATION: This study was registered on Clinicaltrials.gov (clinicaltrials.gov identifier: NCT03650517 ) on August 28th 2018 (study protocol version CI18/02 revision A, 21 February 2018).


Asunto(s)
Colectomía , Neoplasias del Colon , Laparoscopía , Anastomosis Quirúrgica , Estudios de Cohortes , Neoplasias del Colon/cirugía , Humanos , Recurrencia Local de Neoplasia , Pacientes , Complicaciones Posoperatorias , Estudios Prospectivos , Calidad de Vida , Resultado del Tratamiento
19.
Int J Colorectal Dis ; 34(8): 1393-1400, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-31236679

RESUMEN

PURPOSE: Acute appendicitis may present as uncomplicated and complicated and these disease forms differ both epidemiologically and clinically. Complicated acute appendicitis has traditionally been defined as an appendicitis complicated by perforation or a periappendicular abscess, and an appendicolith represents a predisposing factor of complicated disease. There are histopathological differences between uncomplicated acute appendicitis and the previously established traditional forms of complicated acute appendicitis, but to our knowledge, the histopathological differences between uncomplicated acute appendicitis and complicated acute appendicitis presenting with an appendicolith have not yet been reported. The study purpose was to assess these differences with two prospective patient cohorts: (1) computed tomography (CT) confirmed uncomplicated acute appendicitis patients enrolled in the surgical treatment arm of the randomized APPAC trial comparing appendectomy with antibiotics for the treatment of uncomplicated acute appendicitis and (2) patients with CT-verified acute appendicitis presenting with an appendicolith excluded from the APPAC trial. METHODS: The following histopathological parameters were assessed: appendiceal diameter, depth of inflammation, micro-abscesses, density of eosinophils, and neutrophils in appendiceal wall and surface epithelium degeneration. RESULTS: Using multivariable logistic regression models adjusted for age, gender, and symptom duration, statistically significant differences were detected in the depth of inflammation ≤ 2.8 mm (adjusted OR 2.18 (95%CI: 1.29-3.71, p = 0.004), micro-abscesses (adjusted OR 2.16 (95%CI: 1.22-3.83, p = 0.008), the number of eosinophils and neutrophils ≥ 150/mm2 (adjusted OR 0.97 (95%CI: 0.95-0.99, p = 0.013), adjusted OR 3.04 (95%CI: 1.82-5.09, p < 0.001, respectively). CONCLUSIONS: These results corroborate the known clinical association of an appendicolith to complicated acute appendicitis.


Asunto(s)
Apendicitis/complicaciones , Apendicitis/patología , Apéndice/patología , Enfermedad Aguda , Adulto , Femenino , Humanos , Modelos Logísticos , Masculino
20.
Int J Colorectal Dis ; 34(1): 39-46, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30242478

RESUMEN

PURPOSE: Appendiceal tumors are rare, but high neoplasm rates have been reported at interval appendectomy after periappendicular abscess. Non-operative management of uncomplicated acute appendicitis has shown promising results. The data on appendiceal tumor incidence and presentation among acute appendicitis patients is limited, especially in patient cohorts differentiating between uncomplicated and complicated acute appendicitis. Objective was to assess appendiceal tumor incidence and tumor association to appendicitis in patients with uncomplicated and complicated acute appendicitis. METHODS: This nationwide population-based registry study was conducted from 2007 to 2013. The Finnish Cancer Registry and the National Institute for Health Registry were used to combine data on all appendiceal tumors and acute appendicitis diagnosis with medical reports evaluated at eight study hospitals. RESULTS: Altogether, 840 appendiceal tumors were identified, and out of these, 504 patient reports were reviewed, including 472 patients in this study. Tumor was diagnosed at appendectomy for suspected acute appendicitis in 276 patients (58%). In the whole study, histologically acute appendicitis and tumor were both present in 53% (n = 250), and out of these, 41% (n = 102) were complicated and 59% (n = 148) uncomplicated acute appendicitis. The associated tumor risk was significantly higher in complicated acute appendicitis compared with uncomplicated cases (3.24% vs. 0.87%, p < 0.001). Overall tumor prevalence among acute appendicitis patients was 1.24%. CONCLUSIONS: Appendiceal tumor prevalence in acute appendicitis was low. Tumor risk was significantly higher in complicated acute appendicitis compared with uncomplicated acute appendicitis. The risk of missed appendiceal tumors related to antibiotic therapy of uncomplicated acute appendicitis is very low.


Asunto(s)
Neoplasias del Apéndice/epidemiología , Neoplasias del Apéndice/etiología , Apendicitis/complicaciones , Enfermedad Aguda , Neoplasias del Apéndice/patología , Femenino , Finlandia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo
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