Skip to main content
Clinical Trials/NCT04730765
NCT04730765UnknownNot Applicable

Assesment of Quality of Life and Digestive and Genitourinary Functional Sequelae After Elective Left Colectomy for Sigmoid Diverticulitis. National Multicenter Prospective Observational Study

University Hospital, Caen0 sites220 target enrollmentStarted: September 15, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
220
Primary Endpoint
Postoperative HrQoL 6months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)

Study Overview

Brief Summary

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.

Detailed Description

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)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Subjects meeting only one of the following non-inclusion criteria may not be eligible to participate in the research:
  • 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

Arms & Interventions

Surgical Experimental Group

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

Intervention: left elective colectomy (Surgical Experimental Group) (Procedure)

Medical Control Group

Patient not operated and medically treated

Intervention: antibiotic therapy (medical Control Group) (Drug)

Outcomes

Primary Outcomes

Postoperative HrQoL 6months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)

Time Frame: 6 months

The score consists of 36 questions or items rated from 0 to 4 (0 being the worst and 4 the best). The sum of the scores constitutes the overall quality of life score; the ideal score is 144. The items cover 5 dimensions or sub-scales: symptoms (19 items), physical condition (7 items), emotions (5 items), social integration (4 items) and the effect of medical or surgical treatment (1 item). The questionnaire is considered usable if the missing data do not concern more than 2 questions. The QOL score (global and sub-scales) is calculated for all complete answers. 36 questions

Secondary Outcomes

  • Health-related QOL will also be assessed according to the 5 dimensions of the GIQLI but also using the EQ-5D-5L score. The EuroQdV 5-Dimensions 5-Level (EQ-5D-5L)(6 and 12 months)
  • Morbidity and mortality at 90 days will be assessed using the International Classification of Dindo-Clavian Disease and by follow-up(90 days)
  • Hostoperative HrQoL 12months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)(12 months)
  • Digestive sequelae will be assessed using the LARS score, the French version of which is currently being validated, genitourinary sequelae will be assessed using a simplified questionnaire.(6 and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Similar Trials