An observational study in Diverticular Disease of Colon and Quality of Life, sponsored by Städtisches Klinikum München GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by Städtisches Klinikum München GmbH · Observational
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.
23 studies on the registry are indexed under Diverticulosis, Colonic; 4 are open to participants now.
This study's planned enrollment of 165 is below the median of 225 across 10 observational studies indexed under Diverticulosis, Colonic.
Browse Diverticulosis, Colonic studies →Städtisches Klinikum München GmbH is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients > 18 years, matching to inclusion and exclusion criteria, who are scheduled for elective sigmoidectomy for diverticular disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: six month
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 24 month
Peri- und postoperative morbidity
Assessement by use of Clavien-Dindo-Classification
Time frame: 30 days, 6 and 24 month
Mortality
Mortality is defined as 30-days postoperative mortality and mortality in association to diverticulitis recurrency
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 1 day before surgery
Diverticulitis severity: Ambrossetti Classification
CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Ambrossetti Classification
Time frame: 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
Time frame: 1 day before surgery
Diverticulitis severity according to preoperative CT-scan
Evaluation for evidence of pericolic gas
Time frame: 1 day before surgery
Diverticulitis severity according to preoperative CT-scan
Evaluation for evidence of pericolic or pelvic abscess
Time frame: 1 day before surgery
Diverticulitis severity
histological grading of inflammation in the resected bowel (Grade 1-4)
Time frame: 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
Time frame: 6 and 24 month
Postoperative changes in fecal continence
Pre- and postoperative results of Wexner-score
Time frame: 0, 6 and 24 month
Postoperative changes in urinary continence
Pre- and postoperative results of urinary distress inventory (UDI6)
Time frame: 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)
Time frame: 0, 6 and 24 month
Postoperative changes in female sexual function
Assessment of female sexual function by use of Female Sexual Function Index (FSFI)
Time frame: 0, 6 and 24 month
Preoperative fecal calprotectin
Measurement of fecal calprotectin preoperatively
Time frame: 1 day preoperative
Postoperative fecal calprotectin
Measurement of fecal calprotectin postoperatively
Time frame: 6 and 24 month
Morphological changes of the bowel wall
Analysis at the rectosigmoidal junction: overall thickness of the bowel wall
Time frame: 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
Time frame: 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
Time frame: 1 day after surgery
Morphological changes of the bowel wall: Fibrosis
Analysis within the inflamed segment: Grade of fibrosis (1-4)
Time frame: 1 day after surgery
Cost analysis
Review of disease specific health cost by request at health insurance companies
Time frame: baseline and 6 and 24 month
Productivity analysis
Assessment of labour productivity by use of the Productivity Cost Questionnaire (iPCQ)
Time frame: baseline and 6 and 24 month
Started Nov 2017 (actual). Primary completion is estimated for Oct 2024, 83 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Städtisches Klinikum München GmbH