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OpenTrials
Completed

NCT Number: NCT05893095

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

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.

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Key information

Conditions

Diverticular Disease of Colon Colonic Diseases Digestive System Disease Digestive System Diseases Diverticular Diseases Diverticulitis Diverticulitis, Colonic Diverticulosis, Colonic Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Peritoneal Diseases Peritonitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Preferred operation for acute colonic diverticular disease

    Time frame: Up to 78 months

    Laparoscopic peritoneal lavage or sigmoid resection

Secondary outcomes

  1. Crossover surgery

    Time frame: 1 day

    Crossover from laparoscopy to resection surgery

  2. 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

  3. 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

  4. Postoperative length of hospital stay

    Time frame: From date of inclusion until the date of discharge, assessed up to 78 months

  5. 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

  6. Thirty-day postoperative mortality

    Time frame: Up 30 days

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Collaborators

  • Uppsala University

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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