NCT04730765

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Diverticular Disease of Left Side of Colon

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	antibiotic therapy (medical Control Group)	Antibiotic treatement for 10 days by oral or intravenous administration

Timeline

• Start date: 2021-09-15
• Primary completion: 2021-10-30
• Completion: 2022-09-30
• First posted: 2021-01-29
• Last updated: 2021-08-31