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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 : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Maximilian Sohn, Städtisches Klinikum München GmbH

Study Description
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Brief Summary:
To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.

Condition or disease
Diverticular Disease of Colon Quality of Life

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
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Study Type : Observational
Estimated Enrollment : 150 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, 2021
Estimated Study Completion Date : October 31, 2022

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. Peri- und postoperative morbidity [ Time Frame: 30 days, 6 and 24 month ]
    Assessement by use of Clavien-Dindo-Classification

  7. Mortality [ Time Frame: 30 days, 6 and 24 month ]
    Mortality is defined as 30-days postoperative mortality and mortality in association to diverticulitis recurrency

  8. 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

  9. 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).

  10. 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

  11. 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

  12. 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

  13. Diverticulitis severity according to preoperative CT-scan [ Time Frame: 1 day before surgery ]
    Evaluation for evidence of pericolic gas

  14. Diverticulitis severity according to preoperative CT-scan [ Time Frame: 1 day before surgery ]
    Evaluation for evidence of pericolic or pelvic abscess

  15. Diverticulitis severity [ Time Frame: 2 days after surgery ]
    histological grading of inflammation in the resected bowel (Grade 1-4)

  16. 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

  17. Postoperative changes in fecal continence [ Time Frame: 0, 6 and 24 month ]
    Pre- and postoperative results of Wexner-score

  18. Postoperative changes in urinary continence [ Time Frame: 0, 6 and 24 month ]
    Pre- and postoperative results of urinary distress inventory (UDI6)

  19. 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)

  20. 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)

  21. Preoperative fecal calprotectin [ Time Frame: 1 day preoperative ]
    Measurement of fecal calprotectin preoperatively

  22. Postoperative fecal calprotectin [ Time Frame: 6 and 24 month ]
    Measurement of fecal calprotectin postoperatively

  23. Morphological changes of the bowel wall [ Time Frame: 1 day after surgery ]
    Analysis at the rectosigmoidal junction: overall thickness of the bowel wall

  24. 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

  25. 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

  26. Morphological changes of the bowel wall: Fibrosis [ Time Frame: 1 day after surgery ]
    Analysis within the inflamed segment: Grade of fibrosis (1-4)

  27. Cost analysis [ Time Frame: baseline and 6 and 24 month ]
    Review of disease specific health cost by request at health insurance companies

  28. 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
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)

Eligibility Criteria
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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
Study Population
All patients > 18 years, matching to inclusion and exclusion criteria, who are scheduled for elective sigmoidectomy for diverticular disease
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Städtisches Klinikum München GmbH
Investigators
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Study Director: Maximilian Sohn, Dr. med. Städtisches Klinikum München GmbH
More Information
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Responsible Party: Dr. Maximilian Sohn, Dr. med., Attending, Städtisches Klinikum München GmbH
ClinicalTrials.gov Identifier: NCT03527706     History of Changes
Other Study ID Numbers: PREDIC-DIV 1.0
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum
Diverticulosis, Colonic
Intraabdominal Infections
Infection
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases