- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03527706
PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease (PREDIC-DIV)
September 7, 2023 updated by: Dr. Maximilian Sohn, Städtisches Klinikum München GmbH
PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study
To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Observational
Enrollment (Estimated)
165
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maximilian Sohn, Dr. med.
- Phone Number: +49-89-9270702756
- Email: maximilian.sohn@klinikum-muenchen.de
Study Contact Backup
- Name: Francesca Di Cerbo, Dr. med.
- Phone Number: +49-89-92702017
- Email: francesca.cerbo@klinikum-muenchen.de
Study Locations
-
-
Bavaria
-
Munich, Bavaria, Germany, 81925
- Recruiting
- Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH
-
Contact:
- Maximilian Sohn, Dr. med.
- Phone Number: +49-89-9270702756
- Email: maximilian.sohn@klinikum-muenchen.de
-
Contact:
- Francesca Di Cerbo, Dr. med.
- Phone Number: +49-89-92702017
- Email: francesca.cerbo@klinikum-muenchen.de
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients > 18 years, matching to inclusion and exclusion criteria, who are scheduled for elective sigmoidectomy for diverticular disease
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
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
Time Frame: six month
|
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
Time Frame: six month
|
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)
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.
|
six month
|
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
|
24 month
|
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
|
24 month
|
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.
|
24 month
|
Peri- und postoperative morbidity
Time Frame: 30 days, 6 and 24 month
|
Assessement by use of Clavien-Dindo-Classification
|
30 days, 6 and 24 month
|
Mortality
Time Frame: 30 days, 6 and 24 month
|
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)
Time Frame: 0, 6 and 24 month
|
IBS-scoring will be performed pre- and postoperatively by use of ROME IV criteria
|
0, 6 and 24 month
|
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).
|
0, 6 and 24 month
|
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
|
1 day before surgery
|
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
|
1 day before surgery
|
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
|
1 day before surgery
|
Diverticulitis severity according to preoperative CT-scan
Time Frame: 1 day before surgery
|
Evaluation for evidence of pericolic gas
|
1 day before surgery
|
Diverticulitis severity according to preoperative CT-scan
Time Frame: 1 day before surgery
|
Evaluation for evidence of pericolic or pelvic abscess
|
1 day before surgery
|
Diverticulitis severity
Time Frame: 2 days after surgery
|
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
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
|
6 and 24 month
|
Postoperative changes in fecal continence
Time Frame: 0, 6 and 24 month
|
Pre- and postoperative results of Wexner-score
|
0, 6 and 24 month
|
Postoperative changes in urinary continence
Time Frame: 0, 6 and 24 month
|
Pre- and postoperative results of urinary distress inventory (UDI6)
|
0, 6 and 24 month
|
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)
|
0, 6 and 24 month
|
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)
|
0, 6 and 24 month
|
Preoperative fecal calprotectin
Time Frame: 1 day preoperative
|
Measurement of fecal calprotectin preoperatively
|
1 day preoperative
|
Postoperative fecal calprotectin
Time Frame: 6 and 24 month
|
Measurement of fecal calprotectin postoperatively
|
6 and 24 month
|
Morphological changes of the bowel wall
Time Frame: 1 day after surgery
|
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
Time Frame: 1 day after surgery
|
Analysis at the the rectosigmoidal junction: thickness of the muscular layer
|
1 day after surgery
|
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
|
1 day after surgery
|
Morphological changes of the bowel wall: Fibrosis
Time Frame: 1 day after surgery
|
Analysis within the inflamed segment: Grade of fibrosis (1-4)
|
1 day after surgery
|
Cost analysis
Time Frame: baseline and 6 and 24 month
|
Review of disease specific health cost by request at health insurance companies
|
baseline and 6 and 24 month
|
Productivity analysis
Time Frame: baseline and 6 and 24 month
|
Assessment of labour productivity by use of the Productivity Cost Questionnaire (iPCQ)
|
baseline and 6 and 24 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Maximilian Sohn, Dr. med., Städtisches Klinikum München GmbH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2017
Primary Completion (Estimated)
October 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
April 19, 2018
First Submitted That Met QC Criteria
May 16, 2018
First Posted (Actual)
May 17, 2018
Study Record Updates
Last Update Posted (Actual)
September 8, 2023
Last Update Submitted That Met QC Criteria
September 7, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREDIC-DIV 1.0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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