A National Study of Clinical Results After Emergency Operation for Perforated Diverticulitis (LapLav)

April 19, 2023 updated by: Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital, Sweden

A National, Registry Based Study of Clinical Results After Emergency Operation for Perforated Diverticulitis to Compare Laparoscopic Lavage and Resection Surgery in Routine Use.

The aim of this study is to evaluate clinical results and effect on health and well-being in patients operated for perforated diverticulitis with purulent peritonitis by laparoscopic lavage in Sweden when used outside of prospective studies/trials and in comparison with the traditional treatment, i.e. colon resection with or without stoma formation.

A secondary aim is to evaluate the outcome after fecal peritonitis.

The hypothesis is that laparoscopic lavage as treatment for perforated diverticulitis with purulent peritonitis is safe, efficient and cost saving, when used in routine health care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

669

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västa Götaland
      • Gothenburg, Västa Götaland, Sweden, 413 45
        • Sahlgrenska University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All swedish patients registrered within the Swedish Patient Registry with ICD 10 codes K57 classified as emergency admissions and with a NOMESCO code JAH01, JFB46 , JFB60, JFB61, JFB63, JAK04, JAW97.

The cohort will be divided into two groups when analysing and presenting results, perforated diverticulitis with purulent peritonitis (Hinchey grade III) and perforated diverticulitis with faecal peritonitis (Hinchey grade IV) .

Description

Inclusion Criteria:

  • All patients registered in the Patient registry with ICD 10 codes K57 classified as emergency admissions and with the Nordic Medico-Statistical Committee (NOMESCO) code JAH01(diagnostic laparoscopy), JFB46 (resection of sigmoid colon), JFB60 (resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB61 (laparoscopic resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB63 (other colon resection, colostomy and closure of the distal stump), JAK04 (laparoscopy and peritoneal lavage), JAW97 (other laparoscopic operation involving abdominal wall, mesentery, peritoneum or the omentum)

Exclusion Criteria:

  • Patients where hospital records reveal that the index admission was misclassified (not perforated diverticulitis) will be excluded.
  • Patients classified as Hinchey 1-2.
  • No informed consent received or withdrawal of consent (questionnaire)

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
purulent peritonitis
Hinchey 3
Procedure: Laparoscopic lavage
Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3
Procedure: Colon resection
Operation with colon resection for perforated diverticulitis Hinchey 4
faecal peritonitis
Hinchey 4
Procedure: Colon resection
Operation with colon resection for perforated diverticulitis Hinchey 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for further surgical interventions within 12 months of index surgery
Time Frame: 12 months
Number of patients in need of further surgical interventions within 12 months after index surgery.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for further surgical interventions within 24 months of index surgery
Time Frame: 24 months
Number of patients in need of further surgical interventions within 24 months after index surgery.
24 months
Colon cancer diagnosis
Time Frame: 12 months
Number of colon cancer diagnosis within 12 months
12 months
Health economics with regard to the two different treatment modalities.
Time Frame: 2 years
In the analysis data from the study will be combined with prices from the cost-per-patient system at Sveriges Kommuner och Landsting, or where appropriate, from Sahlgrenska University Hospital, in combination with sensitivity testing of results.
2 years
Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.
Time Frame: 36 months
Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively in a national Swedish cohort and in routine health care.
36 months
Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.
Time Frame: 90 days
Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.
90 days
Mortality (90 days and 12 months respectively).
Time Frame: 12 months
Mortality (90 days and 12 months respectively).
12 months
Patient reported outcome after treatment for perforated diverticulitis, function
Time Frame: 3 years
Patient reported outcome as measured using a disease specific questionnaire 2-3 years after index surgery. The questionnaire is developed specifically for this study and will address prevalence, severity and associated distress of symptoms using Likert-type scales regarding function after surgery for perforated diverticulitis.
3 years
Patient reported outcome after treatment for perforated diverticulitis, quality of life
Time Frame: 3 years
Patient reported outcome using a questionnaire sent out 2-3 years after index surgery for perforated diverticulitis, using EQ-5D for quality of life.
3 years

Collaborators and Investigators

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

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Eva Haglind, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 18, 2018

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LapLav

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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