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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 : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Maximilian Sohn, Städtisches Klinikum München GmbH

Tracking Information
First Submitted Date April 19, 2018
First Posted Date May 17, 2018
Last Update Posted Date November 13, 2019
Actual Study Start Date November 28, 2017
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
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
Original Primary Outcome Measures
 (submitted: May 16, 2018)
Postoperative quality of life (QoL) after a follow up of six month: SF-36 [ Time Frame: six month ]
Quality of life will be assessed by use of the SF36- questionnaire
Change History Complete list of historical versions of study NCT03527706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 5, 2019)
  • 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)
Original Secondary Outcome Measures
 (submitted: May 16, 2018)
  • 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 GI-Quality of Life Index-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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease
Official Title PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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)
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
Condition
  • Diverticular Disease of Colon
  • Quality of Life
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 11, 2019)
165
Original Estimated Enrollment
 (submitted: May 16, 2018)
100
Estimated Study Completion Date October 31, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03527706
Other Study ID Numbers PREDIC-DIV 1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Dr. Maximilian Sohn, Städtisches Klinikum München GmbH
Study Sponsor Städtisches Klinikum München GmbH
Collaborators Not Provided
Investigators
Study Director: Maximilian Sohn, Dr. med. Städtisches Klinikum München GmbH
PRS Account Städtisches Klinikum München GmbH
Verification Date November 2019