PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease
- Conditions
- Quality of LifeDiverticular Disease of Colon
- Registration Number
- NCT03527706
- Lead Sponsor
- Städtisches Klinikum München GmbH
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 165
- 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
- ASA 1-3
- informed consent
- Age <18 years
- ASA 4
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative quality of life (QoL) after a follow up of six month: GI-Quality of Life Index six month Quality of life will be assessed by use of the GI-Quality of Life Index
- Secondary Outcome Measures
Name Time Method Postoperative quality of life (QoL) after a follow up of six month: SF36 six month Quality of life will be assessed by use of the SF36-questionnaire
Preoperative fecal calprotectin 1 day preoperative Measurement of fecal calprotectin preoperatively
Cost analysis baseline and 6 and 24 month Review of disease specific health cost by request at health insurance companies
Postoperative quality of life (QoL) after a follow up of six month: Visual analogue scale (VAS) six month Quality of life will be assessed by use of a visual analogue scale (VAS). The scale ranges from 0 to 100 mm. 0 is the least desirable condition. 100 is the most desirable condition.
Quality of life after a follow up of 24 month: SF-36 24 month Quality of life will be assessed by use of SF36-questionnaire
Peri- und postoperative morbidity 30 days, 6 and 24 month Assessement by use of Clavien-Dindo-Classification
Diverticulitis severity: Modified Hinchey Classification 1 day before surgery CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Modified Hinchey Classification
Postoperative changes in urinary continence 0, 6 and 24 month Pre- and postoperative results of urinary distress inventory (UDI6)
Postoperative changes in female sexual function 0, 6 and 24 month Assessment of female sexual function by use of Female Sexual Function Index (FSFI)
Morphological changes of the bowel wall 1 day after surgery Analysis at the rectosigmoidal junction: overall thickness of the bowel wall
Diverticulitis severity according to preoperative CT-scan 1 day before surgery Evaluation for evidence of pericolic or pelvic abscess
Subjective assessment of Diverticulitis severity 0, 6 and 24 month Evaluation of the patients subjective estimate on disease severity by use of a visual analogue scale (VAS). The scale ranges from 0 to 100 mm. 0 is the least desirable condition (=most severe imaginable diverticulitis). 100 is the most desirable condition (=no diverticulitis).
Coexisting characteristics of irritable bowel syndrome (IBS) 0, 6 and 24 month IBS-scoring will be performed pre- and postoperatively by use of ROME IV criteria
Diverticulitis severity: Classification of Diverticular Disease 1 day before surgery CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Classification of Diverticular Disease
Diverticulitis severity 2 days after surgery histological grading of inflammation in the resected bowel (Grade 1-4)
Postoperative changes in male sexual function 0, 6 and 24 month Assessment of male sexual function by use of International index of erectile function (IIEF)
Postoperative fecal calprotectin 6 and 24 month Measurement of fecal calprotectin postoperatively
Morphological changes of the bowel wall: Cells of Cajal 1 day after surgery Analysis within the inflamed segment: amount of Cajal-cells in the bowel wall
Morphological changes of the bowel wall: Fibrosis 1 day after surgery Analysis within the inflamed segment: Grade of fibrosis (1-4)
Quality of life after a follow up of 24 month: GI-Quality of Life Index 24 month Quality of life will be assessed by use GI-Quality of Life index-questionnaire
Quality of life after a follow up of 24 month: Visual analogue scale (VAS) 24 month Quality of life will be assessed by use of a visual analogue scale (VAS). The scale ranges from 0 to 100 mm. 0 is the least desirable condition. 100 is the most desirable condition.
Mortality 30 days, 6 and 24 month Mortality is defined as 30-days postoperative mortality and mortality in association to diverticulitis recurrency
Diverticulitis severity: Ambrossetti Classification 1 day before surgery CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Ambrossetti Classification
Productivity analysis baseline and 6 and 24 month Assessment of labour productivity by use of the Productivity Cost Questionnaire (iPCQ)
Influence of guideline specific treatment on postoperative quality of life 6 and 24 month Postoperative comparison of indication for surgery with given indications in relevant international Guidelines (German, US, Danish, GB, Italian, Dutch). Review of the association between a guideline-matching treatment and postoperative quality of life. Identification of the guideline, which potentially leads to the best achieved quality of life
Postoperative changes in fecal continence 0, 6 and 24 month Pre- and postoperative results of Wexner-score
Morphological changes of the bowel wall: thickness of bowel wall 1 day after surgery Analysis at the the rectosigmoidal junction: thickness of the muscular layer
Trial Locations
- Locations (1)
Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH
🇩🇪Munich, Bavaria, Germany