Clinical trial NCT03332550: A National Study of Clinical Results After Emergency Operation for Perforated Diverticulitis
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perforated Diverticulitis
Keywords: laparoscopic lavage
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 669
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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) .

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Need for further surgical interventions within 12 months of index surgery
timeFrame: 12 months
Secondary outcomes:
measure: Need for further surgical interventions within 24 months of index surgery
timeFrame: 24 months
measure: Colon cancer diagnosis
timeFrame: 12 months
measure: Health economics with regard to the two different treatment modalities.
timeFrame: 2 years
measure: Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.
timeFrame: 36 months
measure: Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.
timeFrame: 90 days
measure: Mortality (90 days and 12 months respectively).
timeFrame: 12 months
measure: Patient reported outcome after treatment for perforated diverticulitis, function
timeFrame: 3 years
measure: Patient reported outcome after treatment for perforated diverticulitis, quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västa Götaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Eva Haglind
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.