NCT03332550

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
669

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

October 10, 2017

Last Update Submit

April 19, 2023

Conditions

Perforated Diverticulitis

Keywords

laparoscopic lavage

Outcome Measures

Primary Outcomes (1)

  • Need for further surgical interventions within 12 months of index surgery

    Number of patients in need of further surgical interventions within 12 months after index surgery.

    12 months

Secondary Outcomes (8)

  • Need for further surgical interventions within 24 months of index surgery

    24 months

  • Colon cancer diagnosis

    12 months

  • Health economics with regard to the two different treatment modalities.

    2 years

  • Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.

    36 months

  • Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.

    90 days

  • +3 more secondary outcomes

Study Arms (2)

purulent peritonitis

Hinchey 3

Procedure: Laparoscopic lavageProcedure: Colon resection

faecal peritonitis

Hinchey 4

Procedure: Colon resection

Interventions

Laparoscopic lavagePROCEDURE

Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3

purulent peritonitis
Colon resectionPROCEDURE

Operation with colon resection for perforated diverticulitis Hinchey 4

faecal peritonitispurulent peritonitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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) .

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västa Götaland, 413 45, Sweden

Location

Related Publications (7)

  • Angenete E, Bock D, Rosenberg J, Haglind E. Laparoscopic lavage is superior to colon resection for perforated purulent diverticulitis-a meta-analysis. Int J Colorectal Dis. 2017 Feb;32(2):163-169. doi: 10.1007/s00384-016-2636-0. Epub 2016 Aug 27.

    PMID: 27567926BACKGROUND

  • Angenete E, Thornell A, Burcharth J, Pommergaard HC, Skullman S, Bisgaard T, Jess P, Lackberg Z, Matthiessen P, Heath J, Rosenberg J, Haglind E. Laparoscopic Lavage Is Feasible and Safe for the Treatment of Perforated Diverticulitis With Purulent Peritonitis: The First Results From the Randomized Controlled Trial DILALA. Ann Surg. 2016 Jan;263(1):117-22. doi: 10.1097/SLA.0000000000001061.

    PMID: 25489672BACKGROUND

  • Gehrman J, Angenete E, Bjorholt I, Bock D, Rosenberg J, Haglind E. Health economic analysis of laparoscopic lavage versus Hartmann's procedure for diverticulitis in the randomized DILALA trial. Br J Surg. 2016 Oct;103(11):1539-47. doi: 10.1002/bjs.10230. Epub 2016 Aug 22.

    PMID: 27548306BACKGROUND

  • Schultz JK, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland T, Yaqub S; SCANDIV Study Group. One-year results of the SCANDIV randomized clinical trial of laparoscopic lavage versus primary resection for acute perforated diverticulitis. Br J Surg. 2017 Sep;104(10):1382-1392. doi: 10.1002/bjs.10567. Epub 2017 Jun 20.

    PMID: 28631827BACKGROUND

  • Vennix S, Musters GD, Mulder IM, Swank HA, Consten EC, Belgers EH, van Geloven AA, Gerhards MF, Govaert MJ, van Grevenstein WM, Hoofwijk AG, Kruyt PM, Nienhuijs SW, Boermeester MA, Vermeulen J, van Dieren S, Lange JF, Bemelman WA; Ladies trial colloborators. Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial. Lancet. 2015 Sep 26;386(10000):1269-1277. doi: 10.1016/S0140-6736(15)61168-0. Epub 2015 Jul 22.

    PMID: 26209030BACKGROUND

  • Thornell A, Angenete E, Bisgaard T, Bock D, Burcharth J, Heath J, Pommergaard HC, Rosenberg J, Stilling N, Skullman S, Haglind E. Laparoscopic Lavage for Perforated Diverticulitis With Purulent Peritonitis: A Randomized Trial. Ann Intern Med. 2016 Feb 2;164(3):137-45. doi: 10.7326/M15-1210. Epub 2016 Jan 19.

    PMID: 26784672BACKGROUND

  • Samuelsson A, Bock D, Prytz M, Block M, Ehrencrona C, Wedin A, Angenete E, Haglind E. Functional Outcomes of Emergency Surgery for Perforated Diverticulitis, Hinchey Grade III. World J Surg. 2023 Jun;47(6):1570-1582. doi: 10.1007/s00268-023-06961-2. Epub 2023 Mar 1.

    PMID: 36856835DERIVED

Study Officials

  • Eva Haglind

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, professor

Study Record Dates

First Submitted

October 10, 2017

First Posted

November 6, 2017

Study Start

April 18, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2022

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)