Colon, Sigmoid, Diverticulum
Conditions
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.
Interventions
PROCEDUREElective laparoscopic sigmoid resection
DIETARY_SUPPLEMENTConservative treatment
Written lifestyle guidance and fiber supplements
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| GIQLI at 12, 24, 48, and 96 months | 12, 24, 48, and 96 months from randomization | — |
| Mortality | 0 - 96 months | — |
| Complications of diverticular disease | 0 - 96 months | — |
| Stoma rate | 0 - 96 months from randomization | — |
| Complications due to elective sigmoid resection | 0 - 96 months from randomization | — |
Countries
Finland
Outcome results
None listed