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

Perforated Diverticulitis Clinical Trial

— LapLav  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332550
• Other study ID #: LapLav
• Status: Completed
• Start date: April 18, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 669
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Diverticulitis
• Emergencies
• Perforated Diverticulitis

Intervention

Procedure:
• Laparoscopic lavage
Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3
• Colon resection
Operation with colon resection for perforated diverticulitis Hinchey 4

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Västa Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2019 Jun 1;393(10187):2200. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Need for further surgical interventions within 24 months of index surgery	Number of patients in need of further surgical interventions within 24 months after index surgery.	24 months
Secondary	Colon cancer diagnosis	Number of colon cancer diagnosis within 12 months	12 months
Secondary	Health economics with regard to the two different treatment modalities.	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
Secondary	Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.	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
Secondary	Complications (Clavien-Dindo = IIIa) within 90 days of index surgery.	Complications (Clavien-Dindo = IIIa) within 90 days of index surgery.	90 days
Secondary	Mortality (90 days and 12 months respectively).	Mortality (90 days and 12 months respectively).	12 months
Secondary	Patient reported outcome after treatment for perforated diverticulitis, function	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
Secondary	Patient reported outcome after treatment for perforated diverticulitis, quality of life	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