PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease

Study Overview
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Brief Summary
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To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.

Detailed Description
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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.

Official Title
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PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study

Conditions
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Diverticular Disease of Colon, Quality of Life

Participation Criteria
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Eligibility Criteria
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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 ASA 1-3 informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative quality of life (QoL) after a follow up of six month: GI-Quality of Life Index | Quality of life will be assessed by use of the GI-Quality of Life Index | six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative quality of life (QoL) after a follow up of six month: SF36 | Quality of life will be assessed by use of the SF36-questionnaire | six month | 
| Postoperative quality of life (QoL) after a follow up of six month: Visual analogue scale (VAS) | 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. | six month | 
| Quality of life after a follow up of 24 month: SF-36 | Quality of life will be assessed by use of SF36-questionnaire | 24 month | 
| Quality of life after a follow up of 24 month: GI-Quality of Life Index | Quality of life will be assessed by use GI-Quality of Life index-questionnaire | 24 month | 
| Quality of life after a follow up of 24 month: Visual analogue scale (VAS) | 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. | 24 month | 
| Peri- und postoperative morbidity | Assessement by use of Clavien-Dindo-Classification | 30 days, 6 and 24 month | 
| Mortality | Mortality is defined as 30-days postoperative mortality and mortality in association to diverticulitis recurrency | 30 days, 6 and 24 month | 
| Coexisting characteristics of irritable bowel syndrome (IBS) | IBS-scoring will be performed pre- and postoperatively by use of ROME IV criteria | 0, 6 and 24 month | 
| Subjective assessment of Diverticulitis severity | 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). | 0, 6 and 24 month | 
| Diverticulitis severity: Classification of Diverticular Disease | CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Classification of Diverticular Disease | 1 day before surgery | 
| Diverticulitis severity: Ambrossetti Classification | CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Ambrossetti Classification | 1 day before surgery | 
| Diverticulitis severity: Modified Hinchey Classification | CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Modified Hinchey Classification | 1 day before surgery | 
| Diverticulitis severity according to preoperative CT-scan | Evaluation for evidence of pericolic gas | 1 day before surgery | 
| Diverticulitis severity according to preoperative CT-scan | Evaluation for evidence of pericolic or pelvic abscess | 1 day before surgery | 
| Diverticulitis severity | histological grading of inflammation in the resected bowel (Grade 1-4) | 2 days after surgery | 
| Influence of guideline specific treatment on postoperative quality of life | 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 | 6 and 24 month | 
| Postoperative changes in fecal continence | Pre- and postoperative results of Wexner-score | 0, 6 and 24 month | 
| Postoperative changes in urinary continence | Pre- and postoperative results of urinary distress inventory (UDI6) | 0, 6 and 24 month | 
| Postoperative changes in male sexual function | Assessment of male sexual function by use of International index of erectile function (IIEF) | 0, 6 and 24 month | 
| Postoperative changes in female sexual function | Assessment of female sexual function by use of Female Sexual Function Index (FSFI) | 0, 6 and 24 month | 
| Preoperative fecal calprotectin | Measurement of fecal calprotectin preoperatively | 1 day preoperative | 
| Postoperative fecal calprotectin | Measurement of fecal calprotectin postoperatively | 6 and 24 month | 
| Morphological changes of the bowel wall | Analysis at the rectosigmoidal junction: overall thickness of the bowel wall | 1 day after surgery | 
| Morphological changes of the bowel wall: thickness of bowel wall | Analysis at the the rectosigmoidal junction: thickness of the muscular layer | 1 day after surgery | 
| Morphological changes of the bowel wall: Cells of Cajal | Analysis within the inflamed segment: amount of Cajal-cells in the bowel wall | 1 day after surgery | 
| Morphological changes of the bowel wall: Fibrosis | Analysis within the inflamed segment: Grade of fibrosis (1-4) | 1 day after surgery | 
| Cost analysis | Review of disease specific health cost by request at health insurance companies | baseline and 6 and 24 month | 
| Productivity analysis | Assessment of labour productivity by use of the Productivity Cost Questionnaire (iPCQ) | baseline and 6 and 24 month |