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

Study Overview
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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.

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

Conditions
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Diverticulum, Colon, Sigmoid

Intervention / Treatment
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* Procedure: Elective laparoscopic sigmoid resection
* Dietary Supplement: Conservative treatment


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative treatment<br>Written lifestyle guidance and fiber supplements | Dietary Supplement: Conservative treatment<br>* Written lifestyle guidance and fiber supplements<br>|
| Experimental: Elective laparoscopic sigmoid resection<br> | Procedure: Elective laparoscopic sigmoid resection<br> <br> |

What is the study measuring?
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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 |