LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
LASER
1 other identifier
interventional
133
1 country
11
Brief Summary
The purpose of this study is to find out whether elective sigmoid resection will improve quality of life compared to conservative treatment with lifestyle guidance and fiber supplement in patients with a recurrent or complicated diverticulitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
11 active sites
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
First Submitted
Initial submission to the registry
June 22, 2014
CompletedFirst Posted
Study publicly available on registry
June 26, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
ExpectedAugust 24, 2020
August 1, 2020
4.6 years
June 22, 2014
August 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Gastrointestinal quality of life-index change at 6 months
Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.
6 months from randomization
Secondary Outcomes (9)
GIQLI at 12, 24, 48, and 96 months
12, 24, 48, and 96 months from randomization
Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months
6, 12, 24, 48, and 96 months from randomization
Recurrence and severity of recurrent diverticulitis
0 - 96 months from randomization
Need of emergency surgery due to diverticulitis
0 - 96 months from randomization
Need of elective sigmoid resection due to diverticulitis (conservative arm)
0 - 96 months from randomization
- +4 more secondary outcomes
Study Arms (2)
Conservative treatment
ACTIVE COMPARATORWritten lifestyle guidance and fiber supplements
Elective laparoscopic sigmoid resection
EXPERIMENTALInterventions
Written lifestyle guidance and fiber supplements
Eligibility Criteria
You may qualify if:
- Recurrent left colon diverticulitis (minimum 3 within 2 years, at least 1 confirmed with CT)
- Earlier complicated left colon diverticulitis
- Prolonged (over 3 months) pain or disturbance in bowel habits after a CT-confirmed left colon diverticulitis
You may not qualify if:
- Multimorbidity that prevents elective surgery
- Contraindication to laparoscopy
- Colonic stricture
- Fistula (e.g. colocutaneous, colovaginal, colovesical)
- Active malignancy
- Earlier resection of sigmoid colon or rectum
- Acute diverticulitis that has not settled
- Colonoscopy/sigmoidoscopy/virtual colonoscopy not performed within 2 years
- Age \< 18 or \> 75 years
- Pregnancy
- Inability to answer health surveys (e.g. dementia, psychiatric condition)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Helsinki University Central Hospital, Jorvi Hospital
Espoo, Finland
Kanta-Häme Central Hospital
Hämeenlinna, Finland
Helsinki University Central Hospital
Helsinki, Finland
North Carelia Central Hospital
Joensuu, Finland
Keski-Suomi Central Hospital
Jyväskylä, Finland
Kuopio University Central Hospital
Kuopio, Finland
Päijät-Häme Central Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Etelä-Pohjanmaa Central Hospital
Seinäjoki, Finland
Turku University Central Hospital
Turku, Finland
Vaasa Central Hospital
Vaasa, Finland
Related Publications (3)
Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lahdesmaki A, Scheinin T, Sallinen V. Sigmoid Resection vs Conservative Treatment After Diverticulitis: Prespecified 4-Year Analysis of the LASER Randomized Clinical Trial. JAMA Surg. 2025 Jun 1;160(6):615-622. doi: 10.1001/jamasurg.2025.0572.
PMID: 40202724DERIVEDSantos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lahdesmaki A, Scheinin T, Sallinen V. Quality-of-Life and Recurrence Outcomes Following Laparoscopic Elective Sigmoid Resection vs Conservative Treatment Following Diverticulitis: Prespecified 2-Year Analysis of the LASER Randomized Clinical Trial. JAMA Surg. 2023 Jun 1;158(6):593-601. doi: 10.1001/jamasurg.2023.0466.
PMID: 37074706DERIVEDSantos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lahdesmaki A, Scheinin T, Sallinen V. Comparing Laparoscopic Elective Sigmoid Resection With Conservative Treatment in Improving Quality of Life of Patients With Diverticulitis: The Laparoscopic Elective Sigmoid Resection Following Diverticulitis (LASER) Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):129-136. doi: 10.1001/jamasurg.2020.5151.
PMID: 33206182DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ville Sallinen, M.D., Ph.D.
Helsinki University Central Hospital
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
- M.D., Ph.D.
Study Record Dates
First Submitted
June 22, 2014
First Posted
June 26, 2014
Study Start
September 1, 2014
Primary Completion
April 1, 2019
Study Completion (Estimated)
December 1, 2027
Last Updated
August 24, 2020
Record last verified: 2020-08