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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uppsala University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Gastrointestinal Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings