Clinical trial NCT04730765: Quality of Life (QOL) After Elective Sigmoidectomy for Diverticular Diseases (DIVERTI)
Official title: Assesment of Quality of Life and Digestive and Genitourinary Functional Sequelae After Elective Left Colectomy for Sigmoid Diverticulitis. National Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diverticular Disease of Left Side of Colon
Keywords: Quality Of Life
Elective colectomy
Diverticular diseases
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Association Francaise de Chirurgie
First posted: 2021-01-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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)

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)

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative HrQoL 6months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)
timeFrame: 6 months
Secondary outcomes:
measure: 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)
timeFrame: 6 and 12 months
measure: Hostoperative HrQoL 12months postoperatively; quality of life will be measured by the Gastrointestinal Quality of Life Index (GIQLI)
timeFrame: 12 months
measure: 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.
timeFrame: 6 and 12 months
measure: Morbidity and mortality at 90 days will be assessed using the International Classification of Dindo-Clavian Disease and by follow-up
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
citation: Bolkenstein HE, Consten ECJ, van der Palen J, van de Wall BJM, Broeders IAMJ, Bemelman WA, Lange JF, Boermeester MA, Draaisma WA; Dutch Diverticular Disease (3D) Collaborative Study Group. Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: 5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial). Ann Surg. 2019 Apr;269(4):612-620. doi: 10.1097/SLA.0000000000003033.
citation: Forgione A, Guraya SY. Elective colonic resection after acute diverticulitis improves quality of life, intestinal symptoms and functional outcome: experts' perspectives and review of literature. Updates Surg. 2016 Mar;68(1):53-8. doi: 10.1007/s13304-016-0349-0. Epub 2016 Mar 25.
citation: Schultz JK, Azhar N, Binda GA, Barbara G, Biondo S, Boermeester MA, Chabok A, Consten ECJ, van Dijk ST, Johanssen A, Kruis W, Lambrichts D, Post S, Ris F, Rockall TA, Samuelsson A, Di Saverio S, Tartaglia D, Thorisson A, Winter DC, Bemelman W, Angenete E. European Society of Coloproctology: guidelines for the management of diverticular disease of the colon. Colorectal Dis. 2020 Sep;22 Suppl 2:5-28. doi: 10.1111/codi.15140. Epub 2020 Jul 7.
citation: Sohn M, Agha A, Iesalnieks I, Bremer S, Trum S, Di Cerbo F, Nerlich A, Lotz N, Klieser E, Hochrein A, Schredl P, Kalcheva D, Emmanuel K, Presl J. PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study. BMJ Open. 2020 Mar 24;10(3):e034385. doi: 10.1136/bmjopen-2019-034385.