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To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.
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.
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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All patients > 18 years, matching to inclusion and exclusion criteria, who are scheduled for elective sigmoidectomy for diverticular disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maximilian Sohn, Dr. med. | Contact | +49-89-9270702756 | maximilian.sohn@klinikum-muenchen.de | |
| Francesca Di Cerbo, Dr. med. | Contact | +49-89-92702017 | francesca.cerbo@klinikum-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Maximilian Sohn, Dr. med. | Städtisches Klinikum München GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH | Recruiting | Munich | Bavaria | 81925 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32209628 | Derived | Sohn M, Agha A, Iesalnieks I, Bremer S, Trum S, Di Cerbo F, Nerlich A, Lotz N, Klieser E, Hochrein A, Schredl P, Kalcheva D, Emmanuel K, Presl J. PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study. BMJ Open. 2020 Mar 24;10(3):e034385. doi: 10.1136/bmjopen-2019-034385. |
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| ID | Term |
|---|---|
| D043963 | Diverticulosis, Colonic |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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The resected part of the bowel is histopathologically examinated and stored routinely for all patients (participants of the study as well as not participating patients)
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 |
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