Quality of Life (QOL) After Elective Sigmoidectomy for Diverticular Diseases (DIVERTI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-09-30

Brief Summary

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Acute diverticulitis of the left colon is among the most common abdominal disorders. To date, both conservative therapy in uncomplicated stages and emergency surgery in perforated disease with peritonitis are consensual. The best treatment strategy for other situations (i.e., smoldering, healed abscesses, recurrences) is still under debate. On the other hand, the best treatment strategy for complicated disease as well as for recurrent stages is still under debate. In these cases, elective surgery can be proposed on a case-by-case basis. Current French guideline recommendations have been updated in 2017. In theory, the objective of elective surgical treatment is to prevent the recurrence and/or complication of the diverticulitis, that might lead to the creation of a stoma. In France, nearly 12,000 prophylactic colectomies for diverticulitis are performed per year. Importantly, elective surgical treatment is associated with the relevant intrinsic morbidity (9.6% major complications within the Sigma Trial), the potential need for unplanned stoma formation of 1%-14% and a significant risk of persisting postoperative complaints. Up to 25% of patients who have undergone a scheduled sigmoid colectomy suffer from ongoing abdominal symptoms. Levack et al found the risk of faecal incontinence to be 24.8% after a sigmoidectomy. Moreover, faecal urgency occurred in 19.6% of patients, and incompleteness of emptying occurred in 20.8%., altering their quality of life (QOL).

To out knowledge, few data are available in the literature concerning the evaluation of QOL after elective sigmoid colectomy. Although QOL was significantly improved after surgery compared to conservative medical treatment, these results were questionable due to the heterogeneity of the studies and the lack of direct comparison of the two therapeutic approaches. Only one recent randomized study reported similar results but this one was prematurely stopped due to inclusion difficulties. The evaluation of digestive and genitourinary functional sequelae is based only on short series, most often retrospective. In summary, evidence on disease-specific characteristics influencing postoperative quality of life is lacking.

The aim of this prospective multicenter study is : (i) to evaluate the QOL and functional sequelae at 6 and 12 months in patients operated on for elective left colectomy and, (ii) to compare them to a population of non-operating diverticulitis patients.

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Detailed Description

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Design The DIVERTI-QOL study is a prospective, multicentre, and observational study. The study will start in February 2021. Recruitment will be completed in July 2021. Overall, the inclusion of 110 patients in each arm is planned. 37 french hospitals agreed to participate in this study.

Allocation for surgery

The allocation to conservative or surgical therapy will be performed at the inclusion in the study. Possible indications for surgery are listed below :

* Persisting abdominal complaints (smouldering diverticular disease) after uncomplicated diverticulitis (Classification of Diverticular Disease (CDD) Stage 1, modified Hinchey 0+Ia).
* Persisting abdominal complaints after covered perforation and/or pericolic 'microabscesses' (1cm) (CDD Stage 2b).
* Chronic or recurrent diverticulitis with persisting abdominal complaints
* diverticulitis complicated by an abscess \>1 cm
* divericulitisin a patient requiring long-term immunosuppressive therapy (with the exception of a neoplastic disease undergoing treatment)

Conditions

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Diverticular Disease of Left Side of Colon

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical Experimental Group

Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis

left elective colectomy (Surgical Experimental Group)

Intervention Type PROCEDURE

Conventional laparoscopic resection of the sigmoid colon is performed using four ports. The left colon is mobilised from the lateral side along Gerota's fascia. The splenic flexure is mobilised at the discretion of surgeons. The mesentery of the sigmoid colon is then medially fenestrated at the promontory level. The superior rectal artery as well as the inferior mesenteric artery and vein are identified and are cut using tissue-sealing devices. A linear stapler device is applied for division of the large intestine. The sigmoid is retracted through a Pfannenstiel incision or enlargement of the left lower abdominal incision. Colorectal anastomosis is performed using a double stapling technique following open resection of the affected colon.

Medical Control Group

Patient not operated and medically treated

antibiotic therapy (medical Control Group)

Intervention Type DRUG

Antibiotic treatement for 10 days by oral or intravenous administration

Interventions

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left elective colectomy (Surgical Experimental Group)

Conventional laparoscopic resection of the sigmoid colon is performed using four ports. The left colon is mobilised from the lateral side along Gerota's fascia. The splenic flexure is mobilised at the discretion of surgeons. The mesentery of the sigmoid colon is then medially fenestrated at the promontory level. The superior rectal artery as well as the inferior mesenteric artery and vein are identified and are cut using tissue-sealing devices. A linear stapler device is applied for division of the large intestine. The sigmoid is retracted through a Pfannenstiel incision or enlargement of the left lower abdominal incision. Colorectal anastomosis is performed using a double stapling technique following open resection of the affected colon.

Intervention Type PROCEDURE

antibiotic therapy (medical Control Group)

Antibiotic treatement for 10 days by oral or intravenous administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient who has received informed information and has not expressed opposition to participation
* Francophone patient
* Patient affiliated to a social security or equivalent system
* Patient taken in charge for :

* smoldering DS after DS Hinchey I
* persistence of symptoms after DS complicated by a peri-sigmoid abscess \<1cm with resolution of inflammation
* DS complicated with an abscess \>1cm (Hinchey II)
* Recurrent episodes of DS
* DS in a patient requiring long-term immunosuppressive therapy (except for neoplastic disease undergoing treatment)
* Patient operated between 01/02/2021 and 30/07/2021, in elective situation of sigmoid diverticulitis (surgical experimental group) or patient not operated and medically treated (medical control group)

* Patient who is a minor or over 70 years of age
* Patient undergoing emergency surgery for sigmoid diverticulitis due to a complication (peritonitis, hemorrhage, failure of drainage diverticular abscess)
* diverticulitis complicated by fistula and/or symptomatic stenosis
* Colorectal resection protected by an ostomy or Hartmann's intervention
* Discovery of colorectal cancer on the operating room
* Patient operated on for diverticulitis of the right colon
* Neoplastic disease under treatment and/or evolving

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No