Impact of Socioeconomic and Territorial Inequalities on Surgical Management of Sigmoid Diverticulitis

NCT06200857 | Completed

• 1 other identifier: 20-510
• Study Type: observational
• Target: 6,800
• Locations: 1 country
• Sites: 1

Brief Summary

Sigmoid diverticulitis (SD) is a common pathology characterized by inflammation/infection of a diverticulum in the sigmoid colon. Surgical treatment of DS is indicated urgently, either because of a serious complication or because of therapeutic failure. Prophylactic surgical treatment of \"cold\" DS is indicated in symptomatic forms (smoldering diverticulitis, frequent recurrences impacting quality of life, symptomatic fistula, and stenosis). It is also indicated for asymptomatic forms in selected patients, to avoid recurrence and/or the occurrence of a DS complication. In France, some 12,000 prophylactic colectomies for DS are performed every year. The mortality rate for this operation during the hospital stay (which does not account for 30-day mortality) is 7 per thousand in France. Morbidity is fairly high, at around 25%, with almost 10% of severe complications. At a distance, the definitive stoma rate is around 6% of patients, and recurrences have been described in up to 10% of cases. Numerous clinical determinants linked to the patient and the pathology have been identified as potential risk factors for morbidity and mortality (advanced age, undernutrition, emergency surgery, neurological history, minimally invasive approach, etc.). Among non-clinical determinants, socio-economic and territorial deprivation is thought to have an impact on postoperative morbidity and mortality for a very large number of pathologies, including cardiovascular disease, cancer, and obesity. Thus, patients from the most disadvantaged backgrounds would have a significantly higher risk of postoperative mortality and morbidity. To our knowledge, however, few data are available on the possible impact of socio-economic deprivation and geographical isolation on the operative outcome of colorectal surgery. This French multicenter study aims to assess the impact of socio-economic and territorial inequalities on the surgical management of sigmoid diverticulitis; with the primary objective being the prevalence of postoperative complications and the secondary objectives being the prevalence of recourse to emergency surgery, minimally invasive surgery, definitive stoma and post-operative recurrence.

Conditions

Sigmoid Diverticulosis; Colorectal Surgery

Keywords

sigmoid diverticulitis _ surgery _ socio-economic inequalities

Outcome Measures

Primary Outcomes (2)

• 90-day morbidity

  From enrollment to the end of treatment at 90 days

• 90-day mortality

  From enrollment to the end of treatment at 90 days

Secondary Outcomes (4)

• - Prevalence of emergency versus prophylactic surgery and type of surgical procedure.

  "From enrollment to the end of treatment at 90 days

• Prevalence of minimally invasive surgery (laparoscopy, robot) versus laparotomy surgery

  "From enrollment to the end of treatment at 90 days

• - Prevalence of definitive stoma

  "From enrollment to the end of treatment at 90 days

• Prevalence of postoperative recurrence

  "From enrollment to the end of treatment at 90 days

Study Arms (1)

association francaise de chirurgie AFC working group

cohort description included all patients aged over 18, undergoing emergency or elective surgery for sigmoid diverticulitis between 2010 and 2019 and with a follow-up of at least 3 months to determine morbi-mortality on the 90th postoperative day. minor patient, those with a final colorectal cancer and those operated on for right colonic diverticulitis were excluded with a follow-up of at least 3 months to determine morbi-mortality on the 90th postoperative day. Non-inclusion criteria for research subjects : * Minor patient * Surgical finding of colorectal cancer The patient operated on for diverticulitis of the right colon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients aged over 18, operated on between 2010 and 2019, for sigmoid diverticulitis * Patients aged 18 and over * Patients undergoing emergency or elective surgery for sigmoid diverticulitis The patient was operated on between January 1, 2010, and December 31, 2019, with a follow-up of at least 3 months to determine morbi-mortality on the 90th postoperative day.

You may qualify if:

• \- Patients aged over 18, operated on between 2010 and 2019, for sigmoid diverticulitis
• Patients aged 18 and over
• Patients undergoing emergency or elective surgery for sigmoid diverticulitis The patient was operated on between January 1, 2010, and December 31, 2019, with a follow-up of at least 3 months to determine morbi-mortality on the 90th postoperative day.

You may not qualify if:

• \- Minor patient
• Surgical finding of colorectal cancer The patient operated on for diverticulitis of the right colon
• Patients with a history of chronic inflammatory bowel disease (Crohn\'s disease, hemorrhagic rectocolitis) and/or hereditary diseases predisposing to colorectal cancer (Lynch syndrome, familial polyposis).

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CAEN University Hospital

Caen, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 11, 2024
• Study Start: January 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)