LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial

NCT ID: NCT02174926

Last Updated: 2020-08-24

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diverticulum Colon, Sigmoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative treatment

Written lifestyle guidance and fiber supplements

Group Type ACTIVE_COMPARATOR

Conservative treatment

Intervention Type DIETARY_SUPPLEMENT

Written lifestyle guidance and fiber supplements

Elective laparoscopic sigmoid resection

Group Type EXPERIMENTAL

Elective laparoscopic sigmoid resection

Intervention Type PROCEDURE

Interventions

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Elective laparoscopic sigmoid resection

Intervention Type PROCEDURE

Conservative treatment

Written lifestyle guidance and fiber supplements

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Recurrent left colon diverticulitis (minimum 3 within 2 years, at least 1 confirmed with CT)

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

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ville Sallinen

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Kanta-Häme Central Hospital

Hämeenlinna, , Finland

Site Status

Helsinki University Central Hospital

Helsinki, , Finland

Site Status

North Carelia Central Hospital

Joensuu, , Finland

Site Status

Keski-Suomi Central Hospital

Jyväskylä, , Finland

Site Status

Kuopio University Central Hospital

Kuopio, , Finland

Site Status

Päijät-Häme Central Hospital

Lahti, , Finland

Site Status

Oulu University Hospital

Oulu, , Finland

Site Status

Etelä-Pohjanmaa Central Hospital

Seinäjoki, , Finland

Site Status

Turku University Central Hospital

Turku, , Finland

Site Status

Vaasa Central Hospital

Vaasa, , Finland

Site Status

Countries

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Finland

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.

Reference Type DERIVED
PMID: 40202724 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37074706 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33206182 (View on PubMed)

Other Identifiers

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LASERtrial

Identifier Type: -

Identifier Source: org_study_id

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