Abstract
STUDY QUESTION
Is there a difference in functional outcomes and recurrence rate between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the ...rectum 5 years postoperatively?
SUMMARY ANSWER
No evidence was found that long-term outcomes differed when nodule excision was compared to rectal resection for deeply invasive endometriosis involving the bowel.
WHAT IS KNOWN ALREADY
Functional outcomes of nodule excision and rectal resection for deeply invasive endometriosis involving the bowel are comparable 2 years after surgery. Despite numerous previously reported case series enrolling patients managed for colorectal endometriosis, long-term data remain scarce in the literature.
STUDY DESIGN, SIZE, DURATION
From March 2011 to August 2013, we performed a two-arm randomized trial, enrolling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring >20 mm in length, involving at least the muscular layer in depth, and up to 50% of rectal circumference. Among them, 55 women were enrolled at one tertial referral centre in endometriosis, using a randomization list drawn up separately for this centre. Institute review board approval was obtained to continue follow-up to 10 years postoperatively. One patient requested to stop the follow-up 2 years after surgery.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Patients underwent either nodule excision by shaving or disc excision, or segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of randomization results. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were values taken from the Knowles–Eccersley–Scott-symptom questionnaire (KESS), the gastrointestinal quality of life index (GIQLI), the Wexner scale, the urinary symptom profile (USP) and the Short Form 36 Health Survey (SF36).
MAIN RESULTS AND THE ROLE OF CHANCE
Fifty-five patients were enrolled. Among the 27 patients in the excision arm, two were converted to segmental resection (7.4%). One patient managed by segmental resection withdrew from the study 2 years postoperatively, presuming that associated pain of other aetiologies may have jeopardized the outcomes. The 5 year-recurrence rate for excision and resection was 3.7% versus 0% (P = 1), respectively. For excision and resection, the primary endpoint was present in 44.4% versus 60.7% of patients (P = 0.29), respectively, while 55.6% versus 53.6% of patients subjectively reported normal bowel movements (P = 1). An intention-to-treat comparison of overall KESS, GIQLI, Wexner, USP and SF36 scores did not reveal significant differences between the two arms 5 years postoperatively. Statistically significant improvement was observed shortly after surgery with no further improvement or impairment recorded 1–5 years postoperatively. During the 5-year follow-up, additional surgical procedures were performed in 25.9% versus 28.6% of patients who had undergone excision or resection (P = 0.80), respectively.
LIMITATIONS, REASONS FOR CAUTION
The presumption of a 40% difference concerning postoperative functional outcomes in favour of nodule excision resulted in a lack of power for demonstration of the primary endpoint difference.
WIDER IMPLICATIONS OF THE FINDINGS
Five-year follow-up data do not show statistically significant differences between conservative and radical rectal surgery for long-term functional digestive and urinary outcomes in this specific population of women with large involvement of the rectum.
STUDY FUNDING/COMPETING INTEREST(S)
No specific funding was received. Patient enrolment and follow-up until 2 years postoperatively was supported by a grant from the clinical research programme for hospitals in France. The authors declare no competing interests related to this study.
TRIAL REGISTRATION NUMBER
This randomized study is registered with ClinicalTrials.gov, number NCT 01291576.
TRIAL REGISTRATION DATE
31 January 2011.
DATE OF FIRST PATIENT’S ENROLMENT
7 March 2011.
To assess the postoperative outcomes of patients with rectal endometriosis managed by disc excision using transanal staplers.
Prospective study using data recorded in the CIRENDO database ...(NCT02294825).
University tertiary referral center.
A total of 111 consecutive patients managed between June 2009 and June 2016.
We performed rectal disc excision using two different transanal staplers: 1 the Contour Transtar stapler (the Rouen technique); and 2 the end to end anastomosis circular transanal stapler.
Pre- and postoperative digestive function was assessed using standardized gastrointestinal questionnaires: the Gastrointestinal Quality of Life Index and the Knowles-Eccersley-Scott Symptom Questionnaire.
The two staplers were used in 42 (37.8%) and 69 patients (62.2%), respectively. The largest diameter of specimens achieved was significantly higher using the Rouen technique (mean ± SD, 59 ± 11 mm vs. 36 ± 7 mm), which was used to remove nodules located lower in the rectum (5.5 ± 1.3 cm vs. 9.7 ± 2.5 cm) infiltrating more frequently the adjacent posterior vaginal wall (83.3% vs. 49.3%). Associated nodules involving sigmoid colon were managed by distinct procedures, either disc excision (2.7%) or segmental resection of sigmoid colon (9.9%). Postoperative values for the Gastrointestinal Quality of Life Index increased 1 and 3 years after the surgery, but improvement in constipation was not significant. The probability of pregnancy at 1 year after the arrest of medical treatment was 73.3% (95% confidence interval 54.9%-88.9%), with a majority of spontaneous conceptions.
Disc excision using transanal staplers is a valuable alternative to colorectal resection in selected patients presenting with rectal endometriosis, allowing for good preservation of rectal function.
Bowel dysfunction before and after surgery for endometriosis Roman, Horace, MD, PhD; Bridoux, Valérie, MD, PhD; Tuech, Jean Jacques, MD, PhD ...
American journal of obstetrics and gynecology,
12/2013, Letnik:
209, Številka:
6
Journal Article
Recenzirano
The relationship between deep fibrotic endometriosis of the rectum and digestive symptoms as well as the impact of surgical treatment on digestive complaints appears increasingly complex. With the ...exception of cases in which the disease leads to rectal stenosis, it seems likely that certain digestive symptoms are a result of cyclic inflammatory phenomena leading to irritation of the digestive tract and not necessarily the result of actual involvement of the rectum by the disease itself because they frequently occur in women free of rectal nodules. Functional or inflammatory bowel diseases and rectal hypersensitivity may be associated with pelvic endometriosis and consequently joepardize the hypothetical causal relationship between the presence of a rectal nodule and digestive complaints. Women treated surgically for rectal endometriosis may continue to experience postoperative digestive complaints, such as constipation. Despite successful surgery free of intra- and postoperative complications and significant improvement in well-being and pelvic pain, several unpleasant digestive symptoms may be incompletely cured by the surgery. Furthermore, de novo postoperative digestive complaints may occur after rectal surgery. Retrospective data suggest that performing colorectal resection is related to less favorable digestive functional outcomes than the use of conservative procedures such as shaving or full-thickness disc excision. These hypotheses need to be confirmed by prospective randomized trials comparing rectal radical and conservative approaches. Bearing in mind the complex relationship between rectal nodules, digestive symptoms and rectal surgery, particular care must be taken in the preoperative assessment of digestive function and in choosing the most suitable surgical procedure.
•Benefit of colostomy on perineal Necrotizing Soft Tissue Infection survival remains uncertain.•Colostomy is associated with a high morbidity and risk of definitive stoma.•If mandatory, a damage ...control strategy using coelioscopic delayed loop left colostomy is advised.•Alternative minimally invasive fecal diversion should also be considered.
Colostomy is usually proposed during the acute phase of Fournier Gangrene, nevertheless its impact on disease outcome remains still debated. We conducted a retrospective study in an academic center to determine the impact of fecal diversion on disease morbidity and specific survival.
All medical charts of Fournier Gangrene cases in the past 30-years were reviewed. Mortality rate, hospitalization duration, time to complete healing and number of excision surgeries were compared between the stoma and the non-stoma groups. Time between initial diagnosis and stoma creation, type of fecal diversion, as well as specific morbidity were analyzed.
Of 89 patients included, 59 had stoma creation. Stoma group had significant higher catecholamine drugs use. Mortality, time to complete healing and number of excision surgeries did not significantly differ between both groups. Hospitalization duration was significantly higher in the stoma group. Mortality and hospitalization duration were higher when loop transverse colostomy was performed, and when colostomy was done in the first 3-days. Morbidity occurred in 41 % of patients with colostomy, with 25 % life-threatening complications. 31 % of colostomies remained definitive, while median time to intestinal recovery was 159-days.
Consistently with current literature, disease survival was not improved by colostomy creation although skewed. Colostomy creation was associated with a higher hospitalization duration and a significant morbidity including risk of definitive stoma. To limit over-indicated stoma and improve early results, a damage control strategy using colostomy creation is advised.
The benefit of colostomy during the acute phase of Fournier Gangrene was uncertain, with no clear impact on mortality. In fact, colostomy was associated with increased hospitalization duration and specific morbidity. Finally, when fecal diversion is deemed necessary, we advocate for coelioscopic delayed loop left colostomy. Alternative minimally invasive treatment as bowel catheters should also be discussed.
An increase in intestinal gas production due to small intestinal bowel overgrowth (SIBO) is a contributing factor for flatus incontinence. The aims of our study were to assess the efficacy of ...metronidazole in a select population of patients with flatus incontinence associated with SIBO and to compare its efficacy with that of a combination of simethicone and activated charcoal (SC; Carbosylane) in randomized experimental arms.
Adult patients suffering from flatus incontinence associated with SIBO diagnosed by a glucose breath test were enrolled in the study. They were given metronidazole or Carbosylane (SC) for 10 days. The reduction in the mean daily number of gas leakages reported in a 3-day diary before and at the end of the treatment was used as the primary endpoint.
Of 52 consecutive subjects with flatus incontinence, 23 (44%) had SIBO, 16 (33%) of whom were included in and completed the study. The relative reduction in flatus incontinence episodes was significantly higher in the metronidazole than in the SC group (66.8±34.8% vs. 25±50%, P = 0.03), decreasing by more than 50% in 7 (87.5%) of the subjects in the metronidazole group compared with only 1 (12.5%) in the SC group (odds ratio 1.9, 95% confidence interval 0.9-56.9, P = 0.06).
Our results show a promising trend indicating that metronidazole might significantly improve flatus incontinence associated with SIBO and might be more successful in treating flatus incontinence than gas absorbents.
AIM: To investigate recurrence rates, patterns and complications after nonoperatively managed complicated diverticulitis(CD).METHODS: A retrospective study of patients treated for CD was performed. ...CD was defined on computed tomography by the presence of a localized abscess, pelvic abscess or extraluminal air. For follow-up, patients were contacted by telephone. Numbers of elective surgeries, recurrences and abdominal pain were analyzed.RESULTS: A total of 114 patients(median age 57 years(range 29-97)), were admitted for CD. Nine patients required surgical intervention for failure of conservative therapy(Hartmann’s procedure: n = 6; resection and colorectal anastomosis: n = 3). Of the 105 remaining patients, 24(22.9%) underwent elective sigmoid resection. The 81(71%) non-operated patients were all contacted after a median follow-up of 32 mo(4-63). Among them, six had developed a recurrent episodeof diverticulitis at a median follow-up of 12 mo(6-36); however, no patient required hospitalization. Sixtyeight patients(84%) were asymptomatic and 13(16%) had recurrent abdominal pain.CONCLUSION: Conservative policy is feasible and safe in 71% of cases, with a low medium-term recurrence risk.
Abstract 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.
Abstract
STUDY QUESTION
Is there a difference in functional outcome between conservative versus radical rectal surgery in patients with large deep endometriosis infiltrating the rectum 2 years ...postoperatively?
SUMMARY ANSWER
No evidence was found that functional outcomes differed when conservative surgery was compared to radical rectal surgery for deeply invasive endometriosis involving the bowel.
WHAT IS KNOWN ALREADY
Adopting a conservative approach to the surgical management of deep endometriosis infiltrating the rectum, by employing shaving or disc excision, appears to yield improved digestive functional outcomes. However, previous comparative studies were not randomized, introducing a possible bias regarding the presumed superiority of conservative techniques due to the inclusion of patients with more severe deep endometriosis who underwent colorectal resection.
STUDY DESIGN SIZE, DURATION
From March 2011 to August 2013, we performed a 2-arm randomized trial, enroling 60 patients with deep endometriosis infiltrating the rectum up to 15 cm from the anus, measuring more than 20 mm in length, involving at least the muscular layer in depth and up to 50% of rectal circumference. No women were lost to follow-up.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Patients were enroled in three French university hospitals and had either conservative surgery, by shaving or disc excision, or radical rectal surgery, by segmental resection. Randomization was performed preoperatively using sequentially numbered, opaque, sealed envelopes, and patients were informed of the results of randomization. The primary endpoint was the proportion of patients experiencing one of the following symptoms: constipation (1 stool/>5 consecutive days), frequent bowel movements (≥3 stools/day), defecation pain, anal incontinence, dysuria or bladder atony requiring self-catheterization 24 months postoperatively. Secondary endpoints were the values of the Visual Analog Scale (VAS), Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), the Gastrointestinal Quality of Life Index (GIQLI), the Wexner scale, the Urinary Symptom Profile (USP) and the Short Form 36 Health Survey (SF36).
MAIN RESULTS AND THE ROLE OF CHANCE
A total of 60 patients were enroled. Among the 27 patients in the conservative surgery arm, two were converted to segmental resection (7.4%). In each group, 13 presented with at least one functional problem at 24 months after surgery (48.1 versus 39.4%, OR = 0.70, 95% CI 0.22-2.21). The intention-to-treat comparison of the overall scores on KESS, GIQLI, Wexner, USP and SF36 did not reveal significant differences between the two arms. Segmental resection was associated with a significant risk of bowel stenosis.
LIMITATIONS REASONS FOR CAUTION
The inclusion of only large infiltrations of the rectum does not allow the extrapolation of conclusions to small nodules of <20 mm in length. The presumption of a 40% difference favourable to conservative surgery in terms of postoperative functional outcomes resulted in a lack of power to demonstrate a difference for the primary endpoint.
WIDER IMPLICATIONS OF THE FINDINGS
Conservative surgery is feasible in patients managed for large deep rectal endometriosis. The trial does not show a statistically significant superiority of conservative surgery for mid-term functional digestive and urinary outcomes in this specific population of women with large involvement of the rectum. There is a higher risk of rectal stenosis after segmental resection, requiring additional endoscopic or surgical procedures.
STUDY FUNDING/COMPETING INTEREST(S)
This work was supported by a grant from the clinical research programme for hospitals (PHRC) in France. The authors declare no competing interests related to this study.
TRIAL REGISTRATION NUMBER
This study is registered with ClinicalTrials.gov, number NCT 01291576.
TRIAL REGISTRATION DATE
31 January 2011.
DATE OF FIRST PATIENT'S ENROLMENT
7 March 2011.
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.
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).
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.
ClinicalTrial.gov: NCT04604730 date of registration October 27, 2020. https://clinicaltrials.gov/ct2/show/NCT04604730?recrs=a&cond=Diverticulitis&draw=2&rank=12 .
To assess the postoperative complications related to three surgical procedures used in colorectal endometriosis: rectal shaving, disc excision, and segmental resection.
Retrospective comparative ...study using data prospectively recorded in the North-West Inter Regional Female Cohort for Patients with Endometriosis (CIRENDO) database.
University tertiary referral center.
A total of 364 consecutive patients with deep endometriosis infiltrating the rectosigmoid, were stratified into three arms according to the technique used.
All patients had a laparoscopic surgical procedure to treat bowel endometriosis: rectal shaving (145 patients), disc excision (80 patients), or segmental colorectal resection (139 patients).
Postoperative complication rate was assessed using Clavien-Dindo classification.
Clavien 3b postoperative complications were recorded in 43 patients (11.8%), two thirds of whom were managed by segmental colorectal resection (P<.001). Fourteen cases of rectovaginal fistula (3.8%) were reported: three in the shaving arm (2.1%), three in the disc excision arm (3.7%), and eight in the segmental colorectal resection arm (5.8%) (P=.13). Twenty-four cases (6.6%) of pelvic abscess were recorded in patients free of fistula or leakage. One year after the surgery pregnancy rate (PRs) and delivery rate were comparable between patients with or without severe complications who intended to get pregnant. Three years postoperatively, the PR in infertile patients was 66.7%, with spontaneous conception in 50% of cases.
Our data suggest that using a strategy prioritizing shaving, whenever it is possible, could be related to a reduction in severe complication rates. However, prudence is required before concluding that extensive disease should not be treated by segmental resection because of the risk of complications.
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