Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study

Completed

• Conditions: Diverticulitis, Colonic; Diverticular Disease of Colon; Gastrointestinal Diseases; Peritonitis; Digestive System Disease

• Registration Number: NCT05893095
• Lead Sponsor: Uppsala University Hospital

Brief Summary

The goal of this observational study is to study the emergency surgical treatment of diverticular disease in Sweden outside clinical trials. The main questions it aims to answer are:

* Which is the preferred surgical method of acute diverticular disease in Sweden?

* Which are the short and long-term outcomes of the different surgical methods?

Researchers will compare the different methods to see if there is a surgical operation that is superior for the treatment of acute diverticulitis.

Detailed Description

A retrospective study of patients who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9) will be included. Patients who underwent procedures relevant to diverticulitis will be identified and therefore will be included. Procedures will be grouped into two categories: Laparoscopic peritoneal lavage (Group I), and sigmoid resection with or without stoma (Group II).

The cohort will be studied from 1st January 1997 until the index date aiming to assess comorbidities, previous abdominal surgeries, and admissions for diverticular disease. A Charlson Comorbidity Index (CCI) system adjusted for Swedish ICD-10 version will be used to calculate a composite score to reflect comorbidity.

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2023-04-20
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-30
• Last Update Submitted: 2023-05-30
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52863

Inclusion Criteria

• All patients aged 18 years or older who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9).
• Emergency admissions.
• Patients who underwent procedures relevant to diverticulitis.

Exclusion Criteria

• Patients who were diagnosed with colorectal cancer before the index date.
• Patients with synchronous operations that are supposed to be irrelevant to acute diverticulitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preferred operation for acute colonic diverticular disease	Up to 78 months	Laparoscopic peritoneal lavage or sigmoid resection

Secondary Outcome Measures

Name	Time	Method
Thirty-day postoperative mortality	Up 30 days
Crossover surgery	1 day	Crossover from laparoscopy to resection surgery
Reoperation	From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months	Disease- associated reoperations involving the bowel or abdominal wall
Postoperative length of hospital stay	From date of inclusion until the date of discharge, assessed up to 78 months
Overall survival	From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months
Colorectal cancer diagnosis	From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months