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

Helsinki University Central Hospital (HUCH)

Status: Active, not recruiting

Conditions: Colon, Sigmoid; Diverticulum

Treatments: Dietary Supplement: Conservative treatment; Procedure: Elective laparoscopic sigmoid resection

Study type: Interventional

Funder types: Other

Identifiers

NCT02174926

LASERtrial

Details and patient eligibility

About

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.

Enrollment: 133 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Conservative treatment

Active Comparator group

Description:

Written lifestyle guidance and fiber supplements

Treatment:

Dietary Supplement: Conservative treatment

Elective laparoscopic sigmoid resection

Experimental group

Treatment:

Procedure: Elective laparoscopic sigmoid resection