PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease

Quality of Life Clinical Trial

— PREDIC-DIV  

Official title:

PREDICtors for Health Related Quality of Life After Elective Sigmoidectomy for DIVerticular Disease: The PREDIC-DIV Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03527706
• Other study ID #: PREDIC-DIV 1.0
• Status: Recruiting
• Start date: November 28, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Städtisches Klinikum München GmbH
• Contact: Maximilian Sohn, Dr. med.
• Phone: +49-89-9270702756
• Email: maximilian.sohn[@]klinikum-muenchen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To identify predictors for postoperative health related quality of life after elective sigmoidectomy for diverticular disease.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diverticular Disease of Colon
• Diverticulosis, Colonic
• Diverticulum
• Quality of Life

Locations

Country	Name	City	State
Germany	Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Städtisches Klinikum München GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	six month
Secondary	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	six month
Secondary	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.	six month
Secondary	Quality of life after a follow up of 24 month: SF-36	Quality of life will be assessed by use of SF36-questionnaire	24 month
Secondary	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	24 month
Secondary	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.	24 month
Secondary	Peri- und postoperative morbidity	Assessement by use of Clavien-Dindo-Classification	30 days, 6 and 24 month
Secondary	Mortality	Mortality is defined as 30-days postoperative mortality and mortality in association to diverticulitis recurrency	30 days, 6 and 24 month
Secondary	Coexisting characteristics of irritable bowel syndrome (IBS)	IBS-scoring will be performed pre- and postoperatively by use of ROME IV criteria	0, 6 and 24 month
Secondary	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).	0, 6 and 24 month
Secondary	Diverticulitis severity: Classification of Diverticular Disease	CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Classification of Diverticular Disease	1 day before surgery
Secondary	Diverticulitis severity: Ambrossetti Classification	CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Ambrossetti Classification	1 day before surgery
Secondary	Diverticulitis severity: Modified Hinchey Classification	CT-scan based grading of diverticulitis in uncomplicated or complicated disease according to Modified Hinchey Classification	1 day before surgery
Secondary	Diverticulitis severity according to preoperative CT-scan	Evaluation for evidence of pericolic gas	1 day before surgery
Secondary	Diverticulitis severity according to preoperative CT-scan	Evaluation for evidence of pericolic or pelvic abscess	1 day before surgery
Secondary	Diverticulitis severity	histological grading of inflammation in the resected bowel (Grade 1-4)	2 days after surgery
Secondary	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	6 and 24 month
Secondary	Postoperative changes in fecal continence	Pre- and postoperative results of Wexner-score	0, 6 and 24 month
Secondary	Postoperative changes in urinary continence	Pre- and postoperative results of urinary distress inventory (UDI6)	0, 6 and 24 month
Secondary	Postoperative changes in male sexual function	Assessment of male sexual function by use of International index of erectile function (IIEF)	0, 6 and 24 month
Secondary	Postoperative changes in female sexual function	Assessment of female sexual function by use of Female Sexual Function Index (FSFI)	0, 6 and 24 month
Secondary	Preoperative fecal calprotectin	Measurement of fecal calprotectin preoperatively	1 day preoperative
Secondary	Postoperative fecal calprotectin	Measurement of fecal calprotectin postoperatively	6 and 24 month
Secondary	Morphological changes of the bowel wall	Analysis at the rectosigmoidal junction: overall thickness of the bowel wall	1 day after surgery
Secondary	Morphological changes of the bowel wall: thickness of bowel wall	Analysis at the the rectosigmoidal junction: thickness of the muscular layer	1 day after surgery
Secondary	Morphological changes of the bowel wall: Cells of Cajal	Analysis within the inflamed segment: amount of Cajal-cells in the bowel wall	1 day after surgery
Secondary	Morphological changes of the bowel wall: Fibrosis	Analysis within the inflamed segment: Grade of fibrosis (1-4)	1 day after surgery
Secondary	Cost analysis	Review of disease specific health cost by request at health insurance companies	baseline and 6 and 24 month
Secondary	Productivity analysis	Assessment of labour productivity by use of the Productivity Cost Questionnaire (iPCQ)	baseline and 6 and 24 month