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

Primary Purpose

Diverticulum, Colon, Sigmoid

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Elective laparoscopic sigmoid resection
Conservative treatment
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticulum

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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)

Sites / Locations

  • Helsinki University Central Hospital, Jorvi Hospital
  • Helsinki University Central Hospital
  • Kanta-Häme Central Hospital
  • North Carelia Central Hospital
  • Keski-Suomi Central Hospital
  • Kuopio University Central Hospital
  • Päijät-Häme Central Hospital
  • Oulu University Hospital
  • Etelä-Pohjanmaa Central Hospital
  • Turku University Central Hospital
  • Vaasa Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conservative treatment

Elective laparoscopic sigmoid resection

Arm Description

Written lifestyle guidance and fiber supplements

Outcomes

Primary Outcome Measures

Gastrointestinal quality of life-index change at 6 months
Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.

Secondary Outcome Measures

GIQLI at 12, 24, 48, and 96 months
Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months
Recurrence and severity of recurrent diverticulitis
Need of emergency surgery due to diverticulitis
Whether or not patient has undergone emergency surgery due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.
Need of elective sigmoid resection due to diverticulitis (conservative arm)
Whether or not patient has undergone elective sigmoid resection due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.
Complications due to elective sigmoid resection
Mortality
Complications of diverticular disease
Stoma rate

Full Information

First Posted
June 22, 2014
Last Updated
August 21, 2020
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02174926
Brief Title
LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
Acronym
LASER
Official Title
LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2014 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulum, Colon, Sigmoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
Written lifestyle guidance and fiber supplements
Arm Title
Elective laparoscopic sigmoid resection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Elective laparoscopic sigmoid resection
Intervention Type
Dietary Supplement
Intervention Name(s)
Conservative treatment
Intervention Description
Written lifestyle guidance and fiber supplements
Primary Outcome Measure Information:
Title
Gastrointestinal quality of life-index change at 6 months
Description
Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.
Time Frame
6 months from randomization
Secondary Outcome Measure Information:
Title
GIQLI at 12, 24, 48, and 96 months
Time Frame
12, 24, 48, and 96 months from randomization
Title
Short form (SF) 36 Health survey score at 6, 12, 24, 48, and 96 months
Time Frame
6, 12, 24, 48, and 96 months from randomization
Title
Recurrence and severity of recurrent diverticulitis
Time Frame
0 - 96 months from randomization
Title
Need of emergency surgery due to diverticulitis
Description
Whether or not patient has undergone emergency surgery due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.
Time Frame
0 - 96 months from randomization
Title
Need of elective sigmoid resection due to diverticulitis (conservative arm)
Description
Whether or not patient has undergone elective sigmoid resection due to diverticulitis during follow-up period. Assessment will be carried out by patient questionnaire and search for patient records.
Time Frame
0 - 96 months from randomization
Title
Complications due to elective sigmoid resection
Time Frame
0 - 96 months from randomization
Title
Mortality
Time Frame
0 - 96 months
Title
Complications of diverticular disease
Time Frame
0 - 96 months
Title
Stoma rate
Time Frame
0 - 96 months from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Sallinen, M.D., Ph.D.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital, Jorvi Hospital
City
Espoo
Country
Finland
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Kanta-Häme Central Hospital
City
Hämeenlinna
Country
Finland
Facility Name
North Carelia Central Hospital
City
Joensuu
Country
Finland
Facility Name
Keski-Suomi Central Hospital
City
Jyväskylä
Country
Finland
Facility Name
Kuopio University Central Hospital
City
Kuopio
Country
Finland
Facility Name
Päijät-Häme Central Hospital
City
Lahti
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Etelä-Pohjanmaa Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Turku University Central Hospital
City
Turku
Country
Finland
Facility Name
Vaasa Central Hospital
City
Vaasa
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33206182
Citation
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.
Results Reference
derived

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

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