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Perforated DiverticulitisLapLavNCT03332550

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

An observational study of Perforated Diverticulitis, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Perforated Diverticulitis
What is being tested?
Laparoscopic lavage and Colon resection
Type of treatment
Surgery or procedure
How many people
669 participants
Where
1 siteSweden
Study dates
18 Apr 2018to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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) .

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, Västa Götaland, 413 45

Other trials in Sweden

About this study

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.

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.

Being tested
Laparoscopic lavage, Colon resection
Keywords
laparoscopic lavage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic lavageProcedure or surgery

    Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3

  • Colon resectionProcedure or surgery

    Operation with colon resection for perforated diverticulitis Hinchey 4

Study groups in NCT03332550
Study groupRoleWhat they receive
purulent peritonitisHinchey 3
Receives: Procedure: Laparoscopic lavage; Procedure: Colon resection
faecal peritonitisHinchey 4
Receives: Procedure: Colon resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (8)

  1. 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.

    Measured: 24 months

  2. Colon cancer diagnosis

    Number of colon cancer diagnosis within 12 months

    Measured: 12 months

  3. 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.

    Measured: 2 years

  4. 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.

    Measured: 36 months

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

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

    Measured: 90 days

  6. Mortality (90 days and 12 months respectively).

    Mortality (90 days and 12 months respectively).

    Measured: 12 months

  7. 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.

    Measured: 3 years

  8. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start18 Apr 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
669 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03332550
Sponsor's protocol ID
LapLav
Acronym
LapLav
Status last verified
Apr 2023
First submitted
10 Oct 2017
Last updated
20 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27567926

  • 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.

    PubMed 25489672

  • 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.

    PubMed 27548306

  • 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.

    PubMed 28631827

  • 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.

    PubMed 26209030

  • 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.

    PubMed 26784672

  • 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.

    PubMed 36856835

Questions about this trial

What is this clinical trial studying?

An observational study of Perforated Diverticulitis, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for further surgical interventions within 12 months of index surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03332550, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.

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