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

Gastrointestinal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05893095
• Other study ID #: 2021-01441
• Status: Completed
• Start date: July 1, 2014
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2023
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52863
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Diverticular Disease of Colon
• Diverticulitis
• Diverticulitis, Colonic
• Diverticulosis, Colonic
• Diverticulum
• Gastrointestinal Diseases
• Peritonitis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University Hospital	Uppsala University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferred operation for acute colonic diverticular disease	Laparoscopic peritoneal lavage or sigmoid resection	Up to 78 months
Secondary	Crossover surgery	Crossover from laparoscopy to resection surgery	1 day
Secondary	Reoperation	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
Secondary	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
Secondary	Postoperative length of hospital stay		From date of inclusion until the date of discharge, assessed up to 78 months
Secondary	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
Secondary	Thirty-day postoperative mortality		Up 30 days