Subject(s)
Fecal Incontinence , Humans , Botulinum Toxins, Type A/administration & dosage , Botulinum Toxins, Type A/therapeutic use , Proctectomy/adverse effects , Postoperative Complications/drug therapy , Postoperative Complications/etiology , Treatment Outcome , Neuromuscular Agents/administration & dosage , Neuromuscular Agents/therapeutic useABSTRACT
AIM: The aim of this work was to investigate the association between early postoperative anastomotic leakage or pelvic abscess (AL/PA) and symptomatic anastomotic stenosis (SAS) in patients after surgery for left colonic diverticulitis. METHOD: This is a retrospective study based on a national cohort of diverticulitis surgery patients carried out by the Association Française de Chirurgie. The assessment was performed using path analyses. The database included 7053 patients operated on for colonic diverticulitis, with surgery performed electively or in an emergency, by open access or laparoscopically. Patients were excluded from the study analysis where there was (i) right-sided diverticulitis (the initial database included all consecutive patients operated on for colonic diverticulitis), (ii) no anastomosis was performed during the first procedure or (iii) missing information about stenosis, postoperative abscess or anastomotic leakage. RESULTS: Of the 4441 patients who were included in the final analysis, AL/PA occurred in 327 (4.6%) and SAS occurred in 82 (1.8%). AL/PA was a significant independent factor associated with a risk for occurrence of SAS (OR = 3.41, 95% CI = 1.75-6.66), as was the case for diverting stoma for ≥100 days (OR = 2.77, 95% CI = 1.32-5.82), while central vessel ligation proximal to the inferior mesenteric artery was associated with a reduced risk (OR = 0.41; 95% CI = 0.19-0.88). Diverting stoma created for <100 days or ≥100 days was also a factor associated with a risk for AL/PA (OR = 3.08, 95% CI = 2-4.75 and OR = 12.95, 95% CI = 9.11-18.50). Interestingly, no significant association between radiological drainage or surgical management of AL/PA and SAS could be highlighted. CONCLUSION: AL/PA was an independent factor associated with the risk for SAS. The treatment of AL/PA was not associated with the occurrence of anastomotic stenosis. Diverting stoma was associated with an increased risk of both AL/PA and SAS, especially if it was left for ≥100 days. Physicians must be aware of this information in order to decide on the best course of action when creating a stoma during elective or emergency surgery.
Subject(s)
Anastomosis, Surgical , Anastomotic Leak , Diverticulitis, Colonic , Humans , Retrospective Studies , Male , Female , Anastomosis, Surgical/adverse effects , Anastomosis, Surgical/methods , Middle Aged , Aged , Anastomotic Leak/etiology , Anastomotic Leak/epidemiology , Diverticulitis, Colonic/surgery , Constriction, Pathologic/etiology , Constriction, Pathologic/surgery , Rectum/surgery , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Colon/surgery , Risk Factors , France/epidemiology , Abscess/etiology , Abscess/surgeryABSTRACT
PURPOSE: Perianal fistulae are disabling complications of Crohn's Disease. Magnetic resonance imaging features could predict treatment response. This study aimed to determine which magnetic resonance imaging features were predictive of long-term clinical outcome in real life. METHODS: Consecutive patients with magnetic resonance imaging performed in a tertiary center were retrospectively analyzed. Clinical outcome was defined as a need for surgical drainage of perianal fistulae or hospitalization. Clinical data and magnetic resonance imaging features (MAGNIFI-CD and Van Assche indices, degree of fibrosis) were studied. RESULTS: Fifty-two patients were included between 2016 and 2019 with a mean follow-up of 38 months [29;48]. A higher MAGNIFI-CD index (17/25 versus 11/25; p < 0.01) was associated with an unfavorable long-term clinical outcome. The MAGNIFI-CD index showed an area under the curve of 0.74 (p = 0.006) to predict the clinical outcome of perianal Crohn's disease, compared to 0.67 (p < 0.05) for the Van Assche index. At a threshold of 13 for the MAGNIFI-CD index, sensitivity was 75% (CI95% [59%; 86%]) and specificity was 69% (CI95% [44%; 86%]). No association was found between the degree of fibrosis and clinical outcome, but the association of a high degree of fibrosis (≥ 80%) and of a low MAGNIFI-CD index (≤ 13) was predictive of clinical outcome (p < 0.01). CONCLUSION: The MAGNIFI-CD index could be used to predict clinical outcome in perianal Crohn's disease. In combination with a high degree of fibrosis, a low MAGNIFI-CD index, may help to identify patients with the best prognosis.
Subject(s)
Crohn Disease , Magnetic Resonance Imaging , Rectal Fistula , Humans , Crohn Disease/diagnostic imaging , Crohn Disease/complications , Male , Female , Magnetic Resonance Imaging/methods , Retrospective Studies , Adult , Rectal Fistula/diagnostic imaging , Rectal Fistula/etiology , Treatment Outcome , Middle Aged , Sensitivity and SpecificityABSTRACT
BACKGROUND: Non-randomised studies assessing intrarectal botulinum toxin type A (BoNTA) injections for faecal incontinence are promising. We aimed to evaluate the efficacy of BoNTA for the treatment of faecal incontinence in a randomised study. METHODS: In this randomised, double-blind, placebo-controlled study, we included adult patients who had at least one urgency or faecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment from eight French specialist hospital units with the skills to manage patients with faecal incontinence. Patients were randomly assigned (1:1) by a central web form to receive intrarectal submucosal injections of either 200 units of BoNTA (Botox; Allergan, Irvine, CA, USA; BoNTA group) or an equivalent volume of saline (placebo group), stratified by Cleveland Clinic Severity scores (CCS score; ≥12 or <12). Patients, investigators, study site staff, and sponsor personnel were masked to treatment allocation up to the 6-month visit. The primary endpoint was the number of episodes of faecal incontinence and urgency per day assessed using 21-day patient bowel diaries 3 months after the treatment. The primary analysis was performed using a modified intention-to-treat (mITT) approach (ie, in all the randomised patients who had received a treatment) with adjustment for baseline faecal incontinence and urgency episodes. After the final data collection at 6 months after injections, patients were unmasked and offered the BoNTA treatment if they were in the placebo group (rescue therapy) without masking, with an additional 6 months of safety follow-up. This trial is registered with ClinicalTrials.gov, number NCT02414425. FINDINGS: Between Nov 25, 2015, and Nov 25, 2020, we randomly assigned 200 patients to receive either BoNTA (n=100) or placebo (n=100) injections. Due to withdrawals before the injections, 96 patients were included in the BoNTA group and 95 patients were included in the placebo group (mITT analysis). The mean number of faecal incontinence and urgency episodes per day in the BoNTA group decreased from 1·9 (SD 2·2) at baseline to 0·8 (1·8) at 3 months after the injections, and from 1·4 (1·1) to 1·0 (1·0) in the placebo group, with a baseline-adjusted mean group difference at 3 months estimated at -0·51 (95% CI -0·80 to -0·21, p=0·0008). No serious treatment-related adverse events were reported in the trial. The most frequently reported non-serious adverse event (treatment related or not) following the BoNTA or placebo injections was constipation (reported in 68 [40%] of 169 patients who received the BoNTA injections and 38 [40%] of 95 patients who received placebo injections). INTERPRETATION: BoNTA injections are an efficacious treatment for urge faecal incontinence. Further research will define the optimum selection criteria, dose, site of injection, re-injection frequency, and long-term results. FUNDING: General Direction of Healthcare (French Ministry of Health).
Subject(s)
Botulinum Toxins, Type A , Fecal Incontinence , Adult , Humans , Fecal Incontinence/drug therapy , Botulinum Toxins, Type A/adverse effects , Treatment Outcome , Constipation/drug therapy , Constipation/chemically inducedABSTRACT
OBJECTIVE: To analyze the surgical management of sigmoid diverticular disease (SDD) before, during, and after the first containment rules (CR) for the first wave of COVID-19. METHODS: From the French Surgical Association multicenter series, this study included all patients operated on between January 2018 and September 2021. Three groups were compared: A (before CR period: 01/01/18-03/16/20), B (CR period: 03/17/20-05/03/20), and C (post CR period: 05/04/20-09/30/21). RESULTS: A total of 1965 patients (A n = 1517, B n = 52, C n = 396) were included. The A group had significantly more previous SDD compared to the two other groups (p = 0.007), especially complicated (p = 0.0004). The rate of peritonitis was significantly higher in the B (46.1%) and C (38.4%) groups compared to the A group (31.7%) (p = 0.034 and p = 0.014). As regards surgical treatment, Hartmann's procedure was more often performed in the B group (44.2%, vs A 25.5% and C 26.8%, p = 0.01). Mortality at 90 days was significantly higher in the B group (9.6%, vs A 4% and C 6.3%, p = 0.034). This difference was also significant between the A and B groups (p = 0.048), as well as between the A and C groups (p = 0.05). There was no significant difference between the three groups in terms of postoperative morbidity. CONCLUSION: This study shows that the management of SDD was impacted by COVID-19 at CR, but also after and until September 2021, both on the initial clinical presentation and on postoperative mortality.
Subject(s)
COVID-19 , Diverticulitis, Colonic , Diverticulum , Humans , Anastomosis, Surgical/methods , Colon, Sigmoid/surgery , Colostomy/methods , Diverticulitis, Colonic/surgery , Diverticulitis, Colonic/complications , Diverticulum/complications , Postoperative Complications , Rectum/surgery , Retrospective StudiesABSTRACT
Pelvic surgery for endometriosis is associated with a risk of bladder and digestive sequelae. Sacral neuromodulation (SNM) has been shown to be effective in the treatment of overactive bladder (OAB) and voiding dysfunction (VD). This study aimed to evaluate the efficacy of sacral neuromodulation (SNM) in treating voiding dysfunction (VD) following endometriosis surgery. A retrospective analysis was conducted on data from women who underwent SNM testing for persistent VD after endometriosis surgery. The study included 21 patients from a French tertiary referral center. Patient characteristics, lower urinary tract symptoms, urodynamic findings, SNM procedures, and outcomes were assessed. The primary outcome was the success of SNM treatment for VD. After a median follow-up of 55 months, 60% of patients achieved successful outcomes, with significant improvements of VD and quality of life. Moreover, more than half of patients who required clean intermittent self-catheterization (CISC) before SNM were able to wean off CISC. Complications such as infections and paraesthesia were observed, but overall, SNM was found to be effective and well tolerated. Age and the interval between endometriosis surgery and SNM testing were associated with treatment success. This study adds to the limited existing literature on SNM for VD after endometriosis surgery and suggests that SNM can be a valuable therapeutic option for these patients. Further research is needed to identify predictive factors and mechanisms underlying the effectiveness of SNM in this context. MRI-compatible and rechargeable devices, has improved the feasibility of SNM for these patients. In conclusion, SNM offers promise as a treatment option for persistent VD after endometriosis surgery, warranting further investigation. LEVEL OF EVIDENCE: 4.
Subject(s)
Electric Stimulation Therapy , Endometriosis , Urinary Bladder, Overactive , Humans , Female , Retrospective Studies , Endometriosis/complications , Endometriosis/surgery , Quality of Life , Electric Stimulation Therapy/methods , Urinary Bladder, Overactive/etiology , Treatment Outcome , SacrumABSTRACT
PURPOSE: Randomized controlled trials (RCTs) are the gold standard tool used to evaluate therapeutic interventions. The published results showed that progress still needs to be made not only from a methodological point of view but also from an ethical point of view. The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in surgery over the last few years. METHODS: All of the articles chosen for review reported on randomized controlled surgical trials and were published in 10 international journals between 2016 and 2020. Eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. Methodological quality was evaluated using the Jadad scale, and ethical quality was evaluated using the Berdeu score. RESULTS: The methodological quality score (Jadad scale) ranged from 5 to 13, with a mean of 10.0 ± 1.54. The methodological quality was insufficient (score ≤ 9) for 162 trials (31.2%). The ethical quality score ranged from 0.25 to 1, with a mean of 0.8 ± 0.11. Fifty-two articles (10%) did not state that informed consent was requested from the participants, and 21 articles (4%) did not report either research ethics committee or institutional committee protocol approval. CONCLUSION: The randomized clinical surgical trials analyzed showed that they had satisfactory methods in only 70% of the cases and that they had respected the fundamental ethical principles in 90% of the cases. However, less than 8% of the studies reported planned interim analysis, prospectively defined stopping rules, and independent monitoring committee.
Subject(s)
Informed Consent , Humans , Randomized Controlled Trials as TopicABSTRACT
AIM: Ano-rectovaginal fistulas (ARVF) are challenging for the surgeon. Most of the series mix aetiologies, leading to confusion with respect to the conclusion. The aim of this study was to assess the factors associated with the success of ARVF management following obstetrical anal sphincter injury (OASIS). METHODS: This retrospective multicentric study included all the patients undergoing surgery for ARVF identified by the hospital codes. Patients for whom the aetiology of ARVF was not OASIS were excluded. The major outcome measure was the success of the procedure. RESULTS: Sixty patients with treated ARVF due to OASIS were identified. The success of overall management was 91.7%. Female patients underwent a mean of 2.5 (±1.7) procedures. A diverting stoma was formed in 29 patients (48.3%) of which 26 were closed at the end of the management period (89.7%). Of the 148 surgical procedures, only 55 were successful (37.2%). The order of the procedures (OR = 1.38; 95% CI: 0.75-2.51) or the diverting stoma (OR = 1.46; 95% CI: 0.31-6.91) were not significantly associated with the success of the surgery. However, Martius flap (OR = 4.13; 95% CI: 1.1-15.54) and Musset procedures (OR = 5.79; 95% CI: 1.77-18.87) produced better results than the endorectal advancement flap (ERAF). The other procedures did not show a significant correlation with management success. CONCLUSION: A diverting stoma is not mandatory in the management of ARVF due to OASIS to improve the success of the surgical procedure. While the Martius flap procedure offers better results, the ERAF procedure may be preferred as a primary intervention in the absence of sphincter injury as it is less invasive. In cases of residual sphincter injury, the Musset procedure is most likely to be the best option.
Subject(s)
Rectal Fistula , Surgical Stomas , Humans , Female , Anal Canal/surgery , Retrospective Studies , Treatment Outcome , Rectovaginal Fistula/etiology , Rectovaginal Fistula/surgery , Surgical Stomas/adverse effects , Rectal Fistula/surgery , Rectal Fistula/complicationsABSTRACT
AIM: Faecal incontinence (FI) subtypes (urge, passive, mixed) are linked to the physiopathological mechanism of FI. Previous studies have failed to demonstrate a consistent relationship between FI subtype and anal sphincter dysfunction. Our aim was to evaluate the relationship between anal sphincter function, assessed using the new EndoFLIP® technology, and FI subtype. METHOD: Patients referred for FI were prospectively enrolled between October 2015 and May 2021 in a registry, and data were retrospectively examined. Each patient underwent a clinical assessment as well as three-dimensional high-resolution or water-perfused anorectal manometry, anal EndoFLIP®, and anorectal electrophysiological and endoanal ultrasound tests. The results of the investigations were compared across FI subtypes. RESULTS: The cohort included 133 patients, 54 (41%) of whom met the criteria for urge FI, 40 (30%) for passive FI and 39 (29%) for mixed FI. The resting anal distensibility index (DI) at 50 ml of distension was significantly lower in patients with urge FI than in patients with passive FI (p = 0.04). At rest, a DI at 50 ml of distension ≥7.3 mm2 mmHg-1 and a DI at 40 ml of distension <1.3 mm2 mmHg-1 were associated with the passive and urge FI subtypes, respectively, with poor discriminatory power (an accuracy of 0.49 compared with 0.33 for random assignment). There were no differences in anorectal manometry, endoanal ultrasound or electrophysiological test results among the urge, passive and mixed FI subgroups (all p > 0.05). CONCLUSION: The anal sphincter DI using the EndoFLIP® system displayed poor predictive performance in distinguishing among FI subtypes.
Subject(s)
Fecal Incontinence , Humans , Fecal Incontinence/diagnostic imaging , Fecal Incontinence/etiology , Fecal Incontinence/pathology , Anal Canal , Retrospective Studies , Manometry/methods , UltrasonographyABSTRACT
BACKGROUND: Traditionally, patients with peritonitis Hinchey III and IV due to perforated diverticulitis were treated with Hartmann's procedure. In the past decade, resection and primary anastomosis have gained popularity over Hartmann's procedure and recent guidelines recommend Hartmann's procedure in two situations only: critically ill patients and in selected patients with multiple comorbidity (at high risk of complications). The protective stoma (PS) is recommended after resection with primary anastomosis, however its interest has never been studied. The aim of this trial is to define the role of systematic PS after resection and primary anastomosis for peritonitis Hinchey III and IV due to perforated diverticulitis. METHODS/DESIGN: This DIVERTI 2 trial is a multicenter, randomized, controlled, superiority trial comparing resection and primary anastomosis with (control group) or without (experimental group) PS in patients with peritonitis Hinchey III and IV due to perforated diverticulitis. Primary endpoint is the overall 1 year morbidity according to the Clavien-Dindo classification of surgical complications. All complications occurring during hospitalization will be collected. Late complications occurring after hospitalization will be collected during follow-up. In order to obtain 80% power for a difference given by respective main probabilities of 67% and 47% in the protective stoma and no protective stoma groups respectively, with a two-sided type I error of 5%, 96 patients will have to be included in each group, hence 192 patients overall. Expecting a 5% rate of patients not assessable for the primary end point (lost to follow-up), 204 patients will be enrolled. Secondary endpoints are postoperative mortality, unplanned reinterventions, incisional surgical site infection (SSI), organ/space SSI, wound disruption, anastomotic leak, operating time, length of hospital stay, stoma at 1 year after initial surgery, quality of life, costs and quality-adjusted life years (QALYs). DISCUSSION: The DIVERTI 2 trial is a prospective, multicenter, randomized, study to define the best strategy between PS and no PS in resection and primary anastomosis for patients presenting with peritonitis due to perforated diverticulitis. TRIAL REGISTRATION: ClinicalTrial.gov: NCT04604730 date of registration October 27, 2020. https://clinicaltrials.gov/ct2/show/NCT04604730?recrs=a&cond=Diverticulitis&draw=2&rank=12 .
Subject(s)
Diverticulitis, Colonic , Diverticulitis , Intestinal Perforation , Peritonitis , Anastomosis, Surgical/adverse effects , Colostomy/adverse effects , Diverticulitis/complications , Diverticulitis/surgery , Diverticulitis, Colonic/complications , Diverticulitis, Colonic/surgery , Humans , Intestinal Perforation/complications , Intestinal Perforation/surgery , Peritonitis/complications , Peritonitis/surgery , Prospective Studies , Quality of Life , Treatment OutcomeABSTRACT
STUDY OBJECTIVE: To compare functional outcomes, recurrence rate, and pregnancy likelihood in patients undergoing conservative or radical surgery for deep rectal endometriosis followed up for 7 years. DESIGN: Prospective study in a cohort of patients enrolled in a 2-arm randomized trial from March 2011 to August 2013. SETTING: A tertiary referral center. PATIENTS: Fifty-five patients with deep endometriosis infiltrating the rectum. INTERVENTIONS: Patients underwent either segmental resection or nodule excision via shaving or disk excision, depending on randomization that was performed preoperatively using sequentially numbered, opaque sealed envelopes. MEASUREMENTS AND MAIN RESULTS: The primary end point was the number of patients experiencing one of the following symptoms: constipation, frequent bowel movements, anal incontinence, or bladder dysfunction 24 months after surgery. The secondary end points were values of gastrointestinal and overall quality of life scores. The 7-year recurrence rates (new deep endometriosis nodules infiltrating the rectum) in the excision vs segmental resection arms were 7.4 % vs 0% (p = .24). One of the symptoms included in the definition of the primary outcomes was recorded in 55.6% vs 60.7% of patients (p = .79). However, 51.9% vs 53.6% of patients considered their bowel movements as normal (p = .99). An intention-to-treat comparison of overall quality of life scores did not find a difference between the 2 groups 7 years after surgery. At the end of the 7-year study period, 31 of 37 patients who tried to conceive were successful (83.8%), including 27 pregnancies (57.4%) resulting from natural conception and 20 pregnancies (42.6%) resulting from assisted reproductive technology procedures. The pregnancy rate was 82.4% vs 85% in the 2 arms (p = .99). A 75.7% live birth rate was recorded. At the end of the follow-up, there were 15 women with 1 child (40.5%) and 13 women with 2 children (35.1%). During the 7-year follow-up, the reoperation rates were 37% and 35.7%, respectively, in each arm (p = .84). Among the 27 reoperation procedures during the follow-up period, 11 (40.7%) were for postoperative complications, 7 (25.9%) were necessary before assisted reproductive technology management, 8 (29.6%) were for recurrent abdominal or pelvic pain, and 1 (3.7%) was for midline ventral hernia after pregnancy. CONCLUSION: Our study did not reveal a considerable difference in terms of digestive functional outcomes, recurrence rate, reoperation risk, and pregnancy likelihood when conservative and radical rectal surgeries for deep endometriosis were compared 7 years after surgery. The postoperative pregnancy rate observed in our series was high.
Subject(s)
Digestive System Surgical Procedures , Endometriosis , Laparoscopy , Rectal Diseases , Child , Digestive System Surgical Procedures/methods , Endometriosis/complications , Female , Follow-Up Studies , Humans , Laparoscopy/adverse effects , Postoperative Complications/etiology , Pregnancy , Prospective Studies , Quality of Life , Rectal Diseases/complications , Treatment OutcomeABSTRACT
AIM: Sacral nerve modulation (SNM) is recommended as a first-line surgical therapy for patients with faecal incontinence (FI). During patient follow-up, it is recommended that stimulation settings be reprogrammed to optimize patient outcomes. The aim of the present study was to evaluate the efficacy of stimulator reprogramming in patients with an implanted SNM device to treat FI. METHOD: The data from patients who received a permanent SNM implant in a single centre from January 2008 to December 2019 were retrospectively analysed. Symptoms that occurred after implantation, the stimulator settings of the SNM device and changes made at each follow-up visit were noted. The efficacy of reprogramming was determined by assessing patient satisfaction. RESULTS: Of the 117 patients (male/female 4/113; mean age 59.5 ± 11.8 years) with a SNM implant for FI, 84 (72%) had at least one symptom requiring reprogramming of the stimulator, most often during the first year after implantation (p = 0.05). The most frequently reported symptoms were loss of efficacy (68.5%; p = 1 × 10-3 ) and pain (20.5%; p = 1 × 10-3 ). Reprogramming was effective 53% of the time when treating loss of efficacy and 76% of the time when treating pain. When the stimulation parameters were reprogrammed at least four consecutive times to correct a symptom, the reprogramming was less effective in treating the symptom (p = 0.02). CONCLUSION: Regular follow-up of patients with SNM device implants associated with reprogramming of stimulation parameters to improve the treatment of reported symptoms would optimize the efficacy of SNM.
Subject(s)
Electric Stimulation Therapy , Fecal Incontinence , Aged , Electric Stimulation Therapy/adverse effects , Electrodes, Implanted , Fecal Incontinence/diagnosis , Fecal Incontinence/surgery , Female , Humans , Lumbosacral Plexus , Male , Middle Aged , Pain/etiology , Retrospective Studies , Sacrum/innervation , Treatment OutcomeABSTRACT
Management of malignant left-sided colonic obstruction remains challenging and requires a stoma in 40-65% of patients. In those with obstructive splenic flexure colon cancer (OSFCC), a debate still exists regarding the most appropriate surgery. The aim of this muticenter study was to report and compare the different surgical procedures in OSFCC patients with a special focus on operative and histological characteristics and survival outcomes including 12-month stoma-free survival. Between 2000 and 2015, 2325 patients were treated for obstructive colon cancer in centers members of the French National Surgical Association (AFC). Among them, 198 underwent surgery for OSFCC and were retrospectively analyzed. Patients with OSFCC and proximal colonic ischemia or perforation were excluded. Four procedures were performed: decompressing stoma (DS, 39%), splenic flexure colectomy (SFC, 39%), subtotal colectomy (STC, 17%,) and left hemicolectomy (LHC, 5%). All patients treated with LHC underwent a Hartmann's procedure. There was no significant difference between groups for postoperative mortality and morbidity. Hospital stay was significantly longer after DS. The length of the specimen, longitudinal resection margins and number of harvested lymph nodes were significantly higher in the STC group. There was no difference for overall and disease-free survival. Stoma-free survival was significantly lower after LHC (62%) in comparison with the other groups (p < 0.0001). At the end of follow-up, 50% of patients who underwent LHC had a permanent stoma. In OSFCC patients without proximal colonic ischemia or peritonitis, LHC should no longer be recommended due to a high risk of permanent stoma.
Subject(s)
Colon, Transverse , Colonic Neoplasms , Intestinal Obstruction , Colectomy , Colon, Transverse/surgery , Colonic Neoplasms/surgery , Humans , Intestinal Obstruction/surgery , Retrospective StudiesABSTRACT
OBJECTIVE: The aim of this study was to compare the survival of patients with stage II obstructing colon cancer (OCC) who had adjuvant chemotherapy with those who did not. SUMMARY BACKGROUND DATA: The need for adjuvant chemotherapy in stage II colon cancer is still debated. METHODS: All consecutive patients treated for a stage II OCC in a curative intent (with primary tumor resection) between January 2000 and December 2015 were included in this retrospective, multicenter cohort study which included a propensity score analysis using an odds of treatment weighting (Average Treatment effect on the Treated, ATT). The endpoint was the comparison between the 2 groups for overall survival (OS) and disease-free survival (DFS) according to whether or not patients received adjuvant chemotherapy. RESULTS: During the study period, 504 patients underwent a curative colectomy for a stage II OCC. Among these patients, 179 (35.5%) had adjuvant chemotherapy and 325 (64.5%) had no adjuvant treatment. Among the 179 patients who received adjuvant chemotherapy, 108 patients (60%) received oxaliplatin based regimen and 99 patients (55%) completed all scheduled cycles. At multivariate analysis, after weighting by the odds (ATT analysis) and adjustment, adjuvant chemotherapy after resection of a stage II OCC was associated with improvements in OS [hazard ratio (HR) = 0.42 (0.17-0.99), P = 0.0498] and DFS [HR = 0.57 (0.37-0.88), P = 0.0116]. CONCLUSION: This study suggests that adjuvant chemotherapy after curative resection of stage II OCC may improve oncological outcomes.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemotherapy, Adjuvant , Colonic Neoplasms/drug therapy , Colonic Neoplasms/surgery , Colonic Neoplasms/mortality , Colonic Neoplasms/pathology , Databases, Factual , Disease-Free Survival , France , Humans , Neoplasm Staging , Oxaliplatin/therapeutic use , Propensity Score , Retrospective Studies , Survival AnalysisABSTRACT
STUDY OBJECTIVE: To assess whether a liberal policy of preventive stoma (LPS) reduces the rate of rectovaginal fistulas in women with excision of deep endometriosis requiring concomitant vaginal and rectal sutures in comparison with a more restrictive policy of preventive stoma (RPS) and to assess the risk factors for rectovaginal fistula. DESIGN: Retrospective before-and-after comparative study. SETTING: Two referral centers, one with an LPS and the other with an RPS. PATIENTS: A total of 363 patients with deep endometriosis infiltrating the rectum and the vagina. INTERVENTIONS: Rectal disc excision or colorectal resection concomitantly with vaginal excision. MEASUREMENTS AND MAIN RESULTS: Two hundred forty-one and 122 women received surgery at the LPS and RPS centers, respectively. The rate of preventive stomas was 71.4% at the LPS center (n = 172) and 30.3% at the RPS center (N = 37). Rectovaginal fistula was recorded in 31 cases (8.5%): nineteen women were managed at the LPS center, and 12 women underwent surgery at the RPS center. It occurred in, respectively, 9.4%, 10.8%, 10.1%, and 7% of the women managed without and with a stoma at the RPS center and of those managed without and with a stoma at the LPS center (p = .72). The height of the rectal stapled line was significantly lower in the women undergoing a stoma, particularly in those managed at the RPS center (5.4 ± 1.8 cm). Performing rectal sutures within 8 cm from the anal verge increased the risk of rectovaginal fistula more than 3-fold, independently of stoma creation, surgical procedure carried out on the rectum, size of vaginal infiltration, or associated excision of deep endometriosis involving the pelvic nerves (odds ratio 3.4; 95% confidence interval, 1.3-9.1). CONCLUSION: No statistically significant differences were found in terms of the risk of rectovaginal fistula between women with rectovaginal endometriosis managed by either an LPS or an RPS; however, these findings need to be confirmed by a randomized trial.
Subject(s)
Endometriosis , Rectal Diseases , Endometriosis/complications , Endometriosis/surgery , Female , Humans , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Rectovaginal Fistula/etiology , Rectovaginal Fistula/prevention & control , Rectovaginal Fistula/surgery , Rectum , Retrospective Studies , Sutures , Treatment Outcome , VaginaABSTRACT
OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.
Subject(s)
Electric Stimulation Therapy , Fecal Incontinence , Aged , Electric Stimulation Therapy/adverse effects , Electric Stimulation Therapy/methods , Fecal Incontinence/surgery , Female , France , Humans , Lumbosacral Plexus , Male , Middle Aged , Retrospective Studies , Treatment OutcomeABSTRACT
AIM: The aim of this work was to assess whether placement of a biological mesh (Permacol® ) between the vaginal and rectal sutures reduces the rate of rectovaginal fistula in patients with deep rectovaginal endometriosis. METHOD: We report a retrospective, comparative study enrolling patients with vaginal infiltration of more than 3 cm in diameter and rectal involvement in two centres. They benefited from complete excision of rectovaginal endometriotic nodules with or without a biological mesh placed between the vaginal and rectal sutures. The rate of rectovaginal fistula was compared between the two groups. RESULTS: Two hundred and nine patients were enrolled: 42 patients underwent interposition of biological mesh (cases) and 167 did not (controls). Ninety-two per cent of cases and 86.2% of controls had rectal infiltration more than 3 cm in diameter. Cases underwent rectal disc excision more frequently (64.3% vs. 49.1%) and had a smaller distance between the rectal staple line and the anal verge (4.4 ± 1.4 cm vs. 6 ± 2.9 cm). Rectovaginal fistulas occurred in 4 cases (9.5%) and 12 controls (7.2%). Logistic regression analyses revealed no difference in the rate of rectovaginal fistula following the use of mesh (adjusted OR 1.6, 95% CI 0.3-9.5). A distance of less than 7 cm between the rectal staple line and the anal verge was found to be an independent risk factor for the development of rectovaginal fistula (adjusted OR 15.1, 95% CI 1.7-132). CONCLUSION: Our results suggest that the placement of a biological mesh between the vagina and rectal sutures may not affect the rate of formation of postoperative rectovaginal fistula following excision of deep infiltrating rectovaginal endometriosis.
Subject(s)
Endometriosis , Rectal Diseases , Endometriosis/surgery , Female , Humans , Pilot Projects , Rectal Diseases/etiology , Rectal Diseases/surgery , Rectovaginal Fistula/etiology , Rectovaginal Fistula/surgery , Retrospective Studies , Surgical Mesh/adverse effects , Treatment OutcomeABSTRACT
STUDY OBJECTIVE: To assess the risk of low anterior resection syndrome (LARS) between women managed by either disk excision or rectal resection for low rectal endometriosis. DESIGN: Retrospective study of a prospective database. SETTING: University hospital. PATIENTS: One hundred seventy-two patients managed by disk excision or rectal resection for deep endometriosis infiltrating the rectum <7 cm from the anal verge. INTERVENTIONS: Rectal disk excision and/or segmental resection using transanal staplers. MEASUREMENTS AND MAIN RESULTS: One hundred eight patients (62.8%) were treated by disk excision (group D) and 64 (37.2%) by rectal resection (group R). All patients answered the LARS score questionnaire. Follow-up was 33.3 ± 22 months for group D (range 12-108 months) and 37.3 ± 22.1 months (range 12-96 months) for group R (p = .25). The rates of rectovaginal fistula and pelvis abscess requiring radiologic drainage and surgery in the D and R groups were, respectively, 7.4% and 8.3% vs 7.8% and 9.3%. The rate of women with normal bowel movements postoperatively was higher in group D (61.1% vs 42.8%, p = .05). Women enrolled in group R reported higher frequency of stools (p <.001), clustering of stools (p = .02), and fecal urgency (p = .05). Regression logistic model revealed 2 independent risk factors for minor/major LARS: performing low rectal resection (adjusted odds ratio 2.28; 95% confidence interval, 1.1-4.7) and presenting with bladder atony requiring self-catheterization beyond postoperative day 7 (adjusted odds ratio 2.52; 95% confidence interval, 1.1-5.8). CONCLUSION: The probability of normal bowel movements is higher after disk excision than after low rectal resection in women with deep endometriosis infiltrating the low rectum.