PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease (PREDIC-DIV)
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ClinicalTrials.gov Identifier: NCT03527706 |
Recruitment Status :
Recruiting
First Posted : May 17, 2018
Last Update Posted : June 15, 2022
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Condition or disease |
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Diverticular Disease of Colon Quality of Life |
Study Type : | Observational |
Estimated Enrollment : | 165 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study |
Actual Study Start Date : | November 28, 2017 |
Estimated Primary Completion Date : | October 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

- 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
- Postoperative quality of life (QoL) after a follow up of six month: SF36 [ Time Frame: six month ]Quality of life will be assessed by use of the SF36-questionnaire
- Postoperative quality of life (QoL) after a follow up of six month: Visual analogue scale (VAS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 30 days, 6 and 24 month ]Assessement by use of Clavien-Dindo-Classification
- Mortality [ Time Frame: 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) [ Time Frame: 0, 6 and 24 month ]IBS-scoring will be performed pre- and postoperatively by use of ROME IV criteria
- Subjective assessment of Diverticulitis severity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 day before surgery ]CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Ambrossetti Classification
- Diverticulitis severity: Modified Hinchey Classification [ Time Frame: 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 [ Time Frame: 1 day before surgery ]Evaluation for evidence of pericolic gas
- Diverticulitis severity according to preoperative CT-scan [ Time Frame: 1 day before surgery ]Evaluation for evidence of pericolic or pelvic abscess
- Diverticulitis severity [ Time Frame: 2 days after surgery ]histological grading of inflammation in the resected bowel (Grade 1-4)
- Influence of guideline specific treatment on postoperative quality of life [ Time Frame: 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 [ Time Frame: 0, 6 and 24 month ]Pre- and postoperative results of Wexner-score
- Postoperative changes in urinary continence [ Time Frame: 0, 6 and 24 month ]Pre- and postoperative results of urinary distress inventory (UDI6)
- Postoperative changes in male sexual function [ Time Frame: 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 [ Time Frame: 0, 6 and 24 month ]Assessment of female sexual function by use of Female Sexual Function Index (FSFI)
- Preoperative fecal calprotectin [ Time Frame: 1 day preoperative ]Measurement of fecal calprotectin preoperatively
- Postoperative fecal calprotectin [ Time Frame: 6 and 24 month ]Measurement of fecal calprotectin postoperatively
- Morphological changes of the bowel wall [ Time Frame: 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 [ Time Frame: 1 day after surgery ]Analysis at the the rectosigmoidal junction: thickness of the muscular layer
- Morphological changes of the bowel wall: Cells of Cajal [ Time Frame: 1 day after surgery ]Analysis within the inflamed segment: amount of Cajal-cells in the bowel wall
- Morphological changes of the bowel wall: Fibrosis [ Time Frame: 1 day after surgery ]Analysis within the inflamed segment: Grade of fibrosis (1-4)
- Cost analysis [ Time Frame: baseline and 6 and 24 month ]Review of disease specific health cost by request at health insurance companies
- Productivity analysis [ Time Frame: baseline and 6 and 24 month ]Assessment of labour productivity by use of the Productivity Cost Questionnaire (iPCQ)
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527706
Contact: Maximilian Sohn, Dr. med. | +49-89-9270702756 | maximilian.sohn@klinikum-muenchen.de | |
Contact: Francesca Di Cerbo, Dr. med. | +49-89-92702017 | francesca.cerbo@klinikum-muenchen.de |
Germany | |
Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH | Recruiting |
Munich, Bavaria, Germany, 81925 | |
Contact: Maximilian Sohn, Dr. med. +49-89-9270702756 maximilian.sohn@klinikum-muenchen.de | |
Contact: Francesca Di Cerbo, Dr. med. +49-89-92702017 francesca.cerbo@klinikum-muenchen.de |
Study Director: | Maximilian Sohn, Dr. med. | Städtisches Klinikum München GmbH |
Responsible Party: | Dr. Maximilian Sohn, Dr. med., Attending, Städtisches Klinikum München GmbH |
ClinicalTrials.gov Identifier: | NCT03527706 |
Other Study ID Numbers: |
PREDIC-DIV 1.0 |
First Posted: | May 17, 2018 Key Record Dates |
Last Update Posted: | June 15, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diverticular Diseases Diverticulum Diverticulosis, Colonic Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Pathological Conditions, Anatomical Colonic Diseases Intestinal Diseases |