NCT03527706RecruitingNot Applicable
PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study
Städtisches Klinikum München GmbH1 site in 1 country165 target enrollmentStarted: November 28, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Postoperative quality of life (QoL) after a follow up of six month: GI-Quality of Life Index
Study Overview
Brief Summary
To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.
Detailed Description
According to current international guidelines, indications for surgical treatment of diverticular disease are inhomogeneous. To date, the measurement of pre- and postoperative quality of life (QoL) is underrepresented. To ensure an individually tailored therapeutical approach, and to avoid unnecessary surgery as well as the risk of a hazardous chronification of the disease, QoL importantly needs to be focused within the decisional process for the best treatment option. The aim of the PREDIC DIV-Study is, to identify predictors for a better postoperative quality of life in patients who undergo elective sigmoidectomy for diverticular disease. PREDIC DIV is a prospective observational study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients, scheduled for elective sigmoidectomy for diverticular disease (Indication: foregoing acute diverticulitis with pericolic or pelvic abscess >1cm, ongoing complaints after acute uncomplicated diverticulitis, recurrent uncomplicated disease (three or more diverticulitis episodes in combination with the patients wish for surgery), recurrent complicated disease (three or more diverticulitis episodes+complications: stenosis, fistula, chronic pain), urgent wish of patients for surgery after uncomplicated disease.
- •Age >18 years
- •informed consent
Exclusion Criteria
- •Age <18 years
- •acute diverticulitis with free perforation
- •acute or forgoing diverticular bleeding
- •colorectal malignancies (current or foregoing)
- •immunosuppression (corticoids > 20 mg prednisolon/d, status post transplant)
- •advanced malignancy with systemic metastases
Outcomes
Primary Outcomes
Postoperative quality of life (QoL) after a follow up of six month: GI-Quality of Life Index
Time Frame: six month
Quality of life will be assessed by use of the GI-Quality of Life Index
Secondary Outcomes
- Postoperative quality of life (QoL) after a follow up of six month: Visual analogue scale (VAS)(six month)
- Quality of life after a follow up of 24 month: SF-36(24 month)
- Peri- und postoperative morbidity(30 days, 6 and 24 month)
- Diverticulitis severity: Modified Hinchey Classification(1 day before surgery)
- Postoperative changes in urinary continence(0, 6 and 24 month)
- Postoperative changes in female sexual function(0, 6 and 24 month)
- Morphological changes of the bowel wall(1 day after surgery)
- Postoperative quality of life (QoL) after a follow up of six month: SF36(six month)
- Preoperative fecal calprotectin(1 day preoperative)
- Cost analysis(baseline and 6 and 24 month)
- Subjective assessment of Diverticulitis severity(0, 6 and 24 month)
- Diverticulitis severity according to preoperative CT-scan(1 day before surgery)
- Postoperative fecal calprotectin(6 and 24 month)
- Morphological changes of the bowel wall: Cells of Cajal(1 day after surgery)
- Coexisting characteristics of irritable bowel syndrome (IBS)(0, 6 and 24 month)
- Diverticulitis severity: Classification of Diverticular Disease(1 day before surgery)
- Diverticulitis severity(2 days after surgery)
- Postoperative changes in male sexual function(0, 6 and 24 month)
- Morphological changes of the bowel wall: Fibrosis(1 day after surgery)
- Quality of life after a follow up of 24 month: GI-Quality of Life Index(24 month)
- Quality of life after a follow up of 24 month: Visual analogue scale (VAS)(24 month)
- Mortality(30 days, 6 and 24 month)
- Diverticulitis severity: Ambrossetti Classification(1 day before surgery)
- Productivity analysis(baseline and 6 and 24 month)
- Influence of guideline specific treatment on postoperative quality of life(6 and 24 month)
- Postoperative changes in fecal continence(0, 6 and 24 month)
- Morphological changes of the bowel wall: thickness of bowel wall(1 day after surgery)
Investigators
Dr. Maximilian Sohn
Dr. med., Attending
Städtisches Klinikum München GmbH
Study Sites (1)
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