NCT01047462

Brief Summary

The purpose of this study is to determine whether laparoscopic lavage changes the rate of severe complications in patients with acute perforated diverticulitis who traditionally are treated with primary resection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

4.8 years

First QC Date

January 12, 2010

Last Update Submit

January 23, 2017

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

  • 90 days complication rate

    90 days

Secondary Outcomes (1)

  • Quality of life

    1 year

Study Arms (2)

Laparoscopic lavage

ACTIVE COMPARATOR
Procedure: Surgery for acute perforated diverticulitis

Primary resection

ACTIVE COMPARATOR
Procedure: Surgery for acute perforated diverticulitis

Interventions

Surgery for acute perforated diverticulitisPROCEDURE

Primary resection vs laparoscopic lavage

Also known as: Hartmann's procedure, Acute diverticulitis, Laparoscopic lavage, Primary resection
Laparoscopic lavagePrimary resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age over 18
  • clinical suspicion of perforated diverticulitis with indication for urgent surgery
  • CT scan with free air and findings suggesting diverticulitis
  • patient tolerates general anaesthesia
  • patients written consent

You may not qualify if:

  • pregnancy
  • bowel obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lorenskog, 1478, Norway

Location

Related Publications (3)

  • Azhar N, Johanssen A, Sundstrom T, Folkesson J, Wallon C, Korner H, Blecic L, Forsmo HM, Oresland T, Yaqub S, Buchwald P, Schultz JK; SCANDIV Study Group. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: Long-term Outcomes From the Scandinavian Diverticulitis (SCANDIV) Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):121-127. doi: 10.1001/jamasurg.2020.5618.

    PMID: 33355658DERIVED

  • 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.

    PMID: 28631827DERIVED

  • Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland T; SCANDIV Study Group. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1364-75. doi: 10.1001/jama.2015.12076.

    PMID: 26441181DERIVED

MeSH Terms

Conditions

Diverticulitis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Tom Oresland, M.D., Ph.D.

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2014

Study Completion

December 1, 2016

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

NO(1)