Diverticular Disease of Colon, Quality of Life
Conditions
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.
Interventions
None listed
Sponsors
Städtisches Klinikum München GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Peri- und postoperative morbidity | 30 days, 6 and 24 month | Assessement by use of Clavien-Dindo-Classification |
| Mortality | 30 days, 6 and 24 month | Mortality is defined as 30-days postoperative mortality and mortality in association to diverticulitis recurrency |
| 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 |
| 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). |
| 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: Ambrossetti Classification | 1 day before surgery | CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Ambrossetti 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 |
| Diverticulitis severity according to preoperative CT-scan | 1 day before surgery | Evaluation for evidence of pericolic gas |
| Diverticulitis severity | 2 days after surgery | histological grading of inflammation in the resected bowel (Grade 1-4) |
| 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 |
| Postoperative changes in fecal continence | 0, 6 and 24 month | Pre- and postoperative results of Wexner-score |
| Postoperative changes in urinary continence | 0, 6 and 24 month | Pre- and postoperative results of urinary distress inventory (UDI6) |
| 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 changes in female sexual function | 0, 6 and 24 month | Assessment of female sexual function by use of Female Sexual Function Index (FSFI) |
| Preoperative fecal calprotectin | 1 day preoperative | Measurement of fecal calprotectin preoperatively |
| Postoperative fecal calprotectin | 6 and 24 month | Measurement of fecal calprotectin postoperatively |
| Morphological changes of the bowel wall | 1 day after surgery | Analysis at the rectosigmoidal junction: overall thickness of the bowel wall |
| 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 |
| 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) |
| Cost analysis | baseline and 6 and 24 month | Review of disease specific health cost by request at health insurance companies |
| 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 |
Countries
Germany
Contacts
Primary ContactMaximilian Sohn, Dr. med.
Backup ContactFrancesca Di Cerbo, Dr. med.
Outcome results
None listed