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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diverticulum; Colon, Sigmoid
• Intervention / Treatment: Dietary supplement: Conservative treatment; Procedure: Elective laparoscopic sigmoid resection

• Study Type: Interventional
• Enrollment (Anticipated): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland
    • Helsinki University Central Hospital, Jorvi Hospital
  • Helsinki, Finland
    • Helsinki University Central Hospital
  • Hämeenlinna, Finland
    • Kanta-Häme Central Hospital
  • Joensuu, Finland
    • North Carelia Central Hospital
  • Jyväskylä, Finland
    • Keski-Suomi Central Hospital
  • Kuopio, Finland
    • Kuopio University Central Hospital
  • Lahti, Finland
    • Päijät-Häme Central hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Seinäjoki, Finland
    • Etelä-Pohjanmaa Central Hospital
  • Turku, Finland
    • Turku University Central Hospital
  • Vaasa, Finland
    • Vaasa Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conservative treatment; Written lifestyle guidance and fiber supplements	Dietary supplement: Conservative treatment; Written lifestyle guidance and fiber supplements
Experimental: Elective laparoscopic sigmoid resection	Procedure: Elective laparoscopic sigmoid resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	0 - 96 months from randomization
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.	0 - 96 months from randomization
Complications due to elective sigmoid resection		0 - 96 months from randomization
Mortality		0 - 96 months
Complications of diverticular disease		0 - 96 months
Stoma rate		0 - 96 months from randomization

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Ville Sallinen, M.D., Ph.D., Helsinki University Central Hospital

Publications and helpful links

General Publications

• Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R, Lähdesmäki 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): April 1, 2019
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: June 22, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Actual): August 24, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticular Diseases; Diverticulitis; Diverticulum
• Other Study ID Numbers: LASERtrial