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

NCT05893095 | Completed

• 1 other identifier: 2021-01441
• Study Type: observational
• Target: 52,863
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Perforated diverticulitis; Purulent peritonitis; Laparoscopic peritoneal lavage

Outcome Measures

Primary Outcomes (1)

• Preferred operation for acute colonic diverticular disease

  Laparoscopic peritoneal lavage or sigmoid resection

  Up to 78 months

Secondary Outcomes (6)

• Crossover surgery

  1 day

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University Hospital: lead
• Uppsala University: collaborator

MeSH Terms

Conditions

Diverticulosis, Colonic; Diverticulitis, Colonic; Peritonitis; Gastrointestinal Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Diverticulitis; Diverticular Diseases; Gastroenteritis; Intraabdominal Infections; Infections; Peritoneal Diseases

Study Officials

• Christos Kollatos, MD

  Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: June 7, 2023
• Study Start: July 1, 2014
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share