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

Caen University Hospital

Status

Unknown

Conditions

Diverticular Disease of Left Side of Colon

Treatments

Drug: antibiotic therapy (medical Control Group)

Procedure: left elective colectomy (Surgical Experimental Group)

Study type

Observational

Funder types

Other

Identifiers

NCT04730765

2020-A02802-37 (Other Identifier)

20-181

Details and patient eligibility

About

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.

Full 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)

Enrollment

220 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)

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