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

Sponsor

Uppsala University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05893095

Collaborator

Uppsala University (Other)

52,863

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticular Disease of Colon Diverticulitis, Colonic Peritonitis Gastrointestinal Diseases Digestive System Disease

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 Design

Study Type:

Observational

Actual Enrollment :

52863 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

Preferred operation for acute colonic diverticular disease [Up to 78 months]
Laparoscopic peritoneal lavage or sigmoid resection

Secondary Outcome Measures

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
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]
Postoperative length of hospital stay [From date of inclusion until the date of discharge, 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]
Thirty-day postoperative mortality [Up 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.