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

May 30, 2023 updated by: Christos Kollatos, Uppsala University Hospital

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

52863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preferred operation for acute colonic diverticular disease
Time Frame: Up to 78 months
Laparoscopic peritoneal lavage or sigmoid resection
Up to 78 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crossover surgery
Time Frame: 1 day
Crossover from laparoscopy to resection surgery
1 day
Reoperation
Time Frame: 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
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
Time Frame: 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
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
Time Frame: From date of inclusion until the date of discharge, assessed up to 78 months
From date of inclusion until the date of discharge, assessed up to 78 months
Colorectal cancer diagnosis
Time Frame: 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
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
Time Frame: Up 30 days
Up 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Collaborators

Uppsala University

Investigators

  • Principal Investigator: Christos Kollatos, MD, Uppsala University Hospital, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 20, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01441

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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