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

N/AActive Not RecruitingNCT02174926

Helsinki University Central Hospital133 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

Diverticulum Colon, Sigmoid

Interventions

Elective laparoscopic sigmoid resectionPROCEDURE

Conservative treatmentDIETARY_SUPPLEMENT

Written lifestyle guidance and fiber supplements

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (11)

Helsinki University Central Hospital, Jorvi Hospital

Espoo, Finland

Kanta-Häme Central Hospital

Hämeenlinna, Finland

Helsinki University Central Hospital

Helsinki, Finland

North Carelia Central Hospital

Outcomes

Primary Outcomes

Gastrointestinal quality of life-index change at 6 months

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

Time frame: 6 months from randomization

Secondary Outcomes

GIQLI at 12, 24, 48, and 96 months

Time frame: 12, 24, 48, and 96 months from randomization

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

Recurrence and severity of recurrent diverticulitis

Time frame: 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.

Time frame: 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.

Time frame: 0 - 96 months from randomization

Complications due to elective sigmoid resection

Time frame: 0 - 96 months from randomization

Mortality

Time frame: 0 - 96 months

Data from ClinicalTrials.gov

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