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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| purulent peritonitis | Hinchey 3 |
| |
| faecal peritonitis | Hinchey 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic lavage | Procedure | Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Colon cancer diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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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) .
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| Name | Affiliation | Role |
|---|---|---|
| Eva Haglind | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Västa Götaland | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27567926 | Background | 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. | |
| 25489672 | Background | 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. |
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| Colon resection | Procedure | Operation with colon resection for perforated diverticulitis Hinchey 4 |
|
Number of colon cancer diagnosis within 12 months
| 12 months |
| 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 |
| 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 |
| Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery. | Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery. | 90 days |
| Mortality (90 days and 12 months respectively). | Mortality (90 days and 12 months respectively). | 12 months |
| 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 |
| 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 |
| 27548306 | Background | 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. |
| 28631827 | Background | 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. |
| 26209030 | Background | 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. |
| 26784672 | Background | 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. |
| 36856835 | Derived | 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. |