LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial
- Conditions
- DiverticulumColon, Sigmoid
- Interventions
- Procedure: Elective laparoscopic sigmoid resectionDietary Supplement: Conservative treatment
- Registration Number
- NCT02174926
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 133
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elective laparoscopic sigmoid resection Elective laparoscopic sigmoid resection - Conservative treatment Conservative treatment Written lifestyle guidance and fiber supplements
- Primary Outcome Measures
Name Time Method Gastrointestinal quality of life-index change at 6 months 6 months from randomization Difference in gastrointestinal quality of life-index (GIQLI) at randomization and 6 months from randomization.
- Secondary Outcome Measures
Name Time Method 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 0 - 96 months from randomization 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) 0 - 96 months from randomization 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 0 - 96 months from randomization Mortality 0 - 96 months Complications of diverticular disease 0 - 96 months Stoma rate 0 - 96 months from randomization
Trial Locations
- Locations (11)
Keski-Suomi Central Hospital
🇫🇮Jyväskylä, Finland
Vaasa Central Hospital
🇫🇮Vaasa, Finland
North Carelia Central Hospital
🇫🇮Joensuu, Finland
Päijät-Häme Central Hospital
🇫🇮Lahti, Finland
Helsinki University Central Hospital, Jorvi Hospital
🇫🇮Espoo, Finland
Kanta-Häme Central Hospital
🇫🇮Hämeenlinna, Finland
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Kuopio University Central Hospital
🇫🇮Kuopio, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Etelä-Pohjanmaa Central Hospital
🇫🇮Seinäjoki, Finland
Turku University Central Hospital
🇫🇮Turku, Finland