Diverticular Disease of ColonPREDIC-DIVNCT03527706
PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease
An observational study of Diverticular Disease of Colon and Quality of Life, run by Städtisches Klinikum München GmbH at 1 site in Germany.
Trial summary
To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease of Colon, Quality of Life
- How many people
- 165 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2017to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients > 18 years, matching to inclusion and exclusion criteria, who are scheduled for elective sigmoidectomy for diverticular disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH
Munich, Bavaria, 81925
Maximilian Sohn, Dr. med., +49-89-9270702756, maximilian.sohn@klinikum-muenchen.de
Francesca Di Cerbo, Dr. med., +49-89-92702017, francesca.cerbo@klinikum-muenchen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Diverticular Disease of Colon, Quality of Life
- Medical subject headings
- Diverticulosis, Colonic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six month
Secondary outcomes (28)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 24 month
Peri- und postoperative morbidity
Assessement by use of Clavien-Dindo-Classification
Measured: 30 days, 6 and 24 month
Mortality
Mortality is defined as 30-days postoperative mortality and mortality in association to diverticulitis recurrency
Measured: 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
Measured: 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).
Measured: 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
Measured: 1 day before surgery
Diverticulitis severity: Ambrossetti Classification
CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Ambrossetti Classification
Measured: 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
Measured: 1 day before surgery
Diverticulitis severity according to preoperative CT-scan
Evaluation for evidence of pericolic gas
Measured: 1 day before surgery
Diverticulitis severity according to preoperative CT-scan
Evaluation for evidence of pericolic or pelvic abscess
Measured: 1 day before surgery
Diverticulitis severity
histological grading of inflammation in the resected bowel (Grade 1-4)
Measured: 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
Measured: 6 and 24 month
Postoperative changes in fecal continence
Pre- and postoperative results of Wexner-score
Measured: 0, 6 and 24 month
Postoperative changes in urinary continence
Pre- and postoperative results of urinary distress inventory (UDI6)
Measured: 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)
Measured: 0, 6 and 24 month
Postoperative changes in female sexual function
Assessment of female sexual function by use of Female Sexual Function Index (FSFI)
Measured: 0, 6 and 24 month
Preoperative fecal calprotectin
Measurement of fecal calprotectin preoperatively
Measured: 1 day preoperative
Postoperative fecal calprotectin
Measurement of fecal calprotectin postoperatively
Measured: 6 and 24 month
Morphological changes of the bowel wall
Analysis at the rectosigmoidal junction: overall thickness of the bowel wall
Measured: 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
Measured: 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
Measured: 1 day after surgery
Morphological changes of the bowel wall: Fibrosis
Analysis within the inflamed segment: Grade of fibrosis (1-4)
Measured: 1 day after surgery
Cost analysis
Review of disease specific health cost by request at health insurance companies
Measured: baseline and 6 and 24 month
Productivity analysis
Assessment of labour productivity by use of the Productivity Cost Questionnaire (iPCQ)
Measured: baseline and 6 and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start28 Nov 2017
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diverticular Disease of ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Städtisches Klinikum München GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Maximilian Sohn, Städtisches Klinikum München GmbH
- Investigators
- Maximilian Sohn, Dr. med., Study director, Städtisches Klinikum München GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527706
- Sponsor's protocol ID
- PREDIC-DIV 1.0
- Acronym
- PREDIC-DIV
- Status last verified
- Sep 2023
- First submitted
- 19 Apr 2018
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32209628
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study
- ClinicalTrials.gov ID
- NCT03527706
- Acronym / sponsor ID
- PREDIC-DIV / PREDIC-DIV 1.0
- Conditions
- Diverticular Disease of Colon, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Städtisches Klinikum München GmbHUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients > 18 years, matching to inclusion and exclusion criteria, who are scheduled for elective sigmoidectomy for diverticular disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Age <18 years
- ASA 4
- acute diverticulitis with free perforation
- acute or forgoing diverticular bleeding
- colorectal malignancies (current or foregoing)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
28 secondary outcomes
Postoperative quality of life (QoL) after a follow up of six month: SF36
Time frame: 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 after a follow up of 24 month: SF-36
Time frame: 24 month
Quality of life after a follow up of 24 month: GI-Quality of Life Index
Time frame: 24 month
Quality of life after a follow up of 24 month: Visual analogue scale (VAS)
Time frame: 24 month
Peri- und postoperative morbidity
Time frame: 30 days, 6 and 24 month
Mortality
Time frame: 30 days, 6 and 24 month
Coexisting characteristics of irritable bowel syndrome (IBS)
Time frame: 0, 6 and 24 month
Subjective assessment of Diverticulitis severity
Time frame: 0, 6 and 24 month
Diverticulitis severity: Classification of Diverticular Disease
Time frame: 1 day before surgery
Diverticulitis severity: Ambrossetti Classification
Time frame: 1 day before surgery
Diverticulitis severity: Modified Hinchey Classification
Time frame: 1 day before surgery
Diverticulitis severity according to preoperative CT-scan
Time frame: 1 day before surgery
Diverticulitis severity according to preoperative CT-scan
Time frame: 1 day before surgery
Diverticulitis severity
Time frame: 2 days after surgery
Influence of guideline specific treatment on postoperative quality of life
Time frame: 6 and 24 month
Postoperative changes in fecal continence
Time frame: 0, 6 and 24 month
Postoperative changes in urinary continence
Time frame: 0, 6 and 24 month
Postoperative changes in male sexual function
Time frame: 0, 6 and 24 month
Postoperative changes in female sexual function
Time frame: 0, 6 and 24 month
Preoperative fecal calprotectin
Time frame: 1 day preoperative
Postoperative fecal calprotectin
Time frame: 6 and 24 month
Morphological changes of the bowel wall
Time frame: 1 day after surgery
Morphological changes of the bowel wall: thickness of bowel wall
Time frame: 1 day after surgery
Morphological changes of the bowel wall: Cells of Cajal
Time frame: 1 day after surgery
Morphological changes of the bowel wall: Fibrosis
Time frame: 1 day after surgery
Cost analysis
Time frame: baseline and 6 and 24 month
Productivity analysis
Time frame: baseline and 6 and 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 32209628Sohn 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maximilian Sohn, Dr. med. study director
Städtisches Klinikum München GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease of Colon and Quality of Life, run by Städtisches Klinikum München GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maximilian Sohn, Dr. med. (+49-89-9270702756, maximilian.sohn@klinikum-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative quality of life (QoL) after a follow up of six month: GI-Quality of Life Index (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03527706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.