PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease

Städtisches Klinikum München GmbH165 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Diverticular Disease of Colon Quality of Life

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH

Munich, Bavaria, Germany

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Maximilian Sohn, Dr. med.

CONTACT

+49-89-9270702756 maximilian.sohn@klinikum-muenchen.de

Francesca Di Cerbo, Dr. med.

CONTACT

+49-89-92702017 francesca.cerbo@klinikum-muenchen.de

Data from ClinicalTrials.gov

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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