Clinical trial NCT05893095: Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study
Official title: Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diverticular Disease of Colon
Diverticulitis, Colonic
Peritonitis
Gastrointestinal Diseases
Digestive System Disease
Keywords: Perforated diverticulitis
Purulent peritonitis
Laparoscopic peritoneal lavage
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2023-06-07
Enrollment: 52863
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be based on a national cohort gathered from National Patient Register, the National Cancer Register and the Cause of Death Register, obtained by the Swedish National Board of Health and Welfare.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Preferred operation for acute colonic diverticular disease
timeFrame: Up to 78 months
Secondary outcomes:
measure: Crossover surgery
timeFrame: 1 day
measure: Reoperation
timeFrame: 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
measure: Overall survival
timeFrame: 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
measure: Postoperative length of hospital stay
timeFrame: From date of inclusion until the date of discharge, assessed up to 78 months
measure: Colorectal cancer diagnosis
timeFrame: 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
measure: Thirty-day postoperative mortality
timeFrame: Up 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University Hospital, Sweden
name: Christos Kollatos, MD
role: PRINCIPAL_INVESTIGATOR
References: