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

NCT ID: NCT03332550

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

669 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-18

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perforated Diverticulitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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purulent peritonitis

Hinchey 3

Laparoscopic lavage

Intervention Type PROCEDURE

Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3

Colon resection

Intervention Type PROCEDURE

Operation with colon resection for perforated diverticulitis Hinchey 4

faecal peritonitis

Hinchey 4

Colon resection

Intervention Type PROCEDURE

Operation with colon resection for perforated diverticulitis Hinchey 4

Interventions

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Laparoscopic lavage

Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3

Intervention Type PROCEDURE

Colon resection

Operation with colon resection for perforated diverticulitis Hinchey 4

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eva Haglind, MD, PhD, professor

MD, PhD, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Haglind

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Sahlgrenska University Hospital

Gothenburg, Västa Götaland, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 27567926 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25489672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27548306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28631827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26209030 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26784672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36856835 (View on PubMed)

Other Identifiers

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LapLav

Identifier Type: -

Identifier Source: org_study_id

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