LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
NCT ID: NCT02174926
Last Updated: 2020-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
133 participants
INTERVENTIONAL
2014-09-30
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conservative treatment
Written lifestyle guidance and fiber supplements
Conservative treatment
Written lifestyle guidance and fiber supplements
Elective laparoscopic sigmoid resection
Elective laparoscopic sigmoid resection
Interventions
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Elective laparoscopic sigmoid resection
Conservative treatment
Written lifestyle guidance and fiber supplements
Eligibility Criteria
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Inclusion Criteria
OR
* Earlier complicated left colon diverticulitis
OR
* Prolonged (over 3 months) pain or disturbance in bowel habits after a CT-confirmed left colon diverticulitis
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Ville Sallinen
M.D., Ph.D.
Principal Investigators
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Ville Sallinen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
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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
Countries
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References
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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.
Santos 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.
Santos 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.
Other Identifiers
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LASERtrial
Identifier Type: -
Identifier Source: org_study_id
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