Clinical trial NCT03527706: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diverticular Disease of Colon
Quality of Life
Lead sponsor: Städtisches Klinikum München GmbH
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Postoperative quality of life (QoL) after a follow up of six month: GI-Quality of Life Index
timeFrame: six month
Secondary outcomes:
measure: Postoperative quality of life (QoL) after a follow up of six month: SF36
timeFrame: six month
measure: Postoperative quality of life (QoL) after a follow up of six month: Visual analogue scale (VAS)
timeFrame: six month
measure: Quality of life after a follow up of 24 month: SF-36
timeFrame: 24 month
measure: Quality of life after a follow up of 24 month: GI-Quality of Life Index
timeFrame: 24 month
measure: Quality of life after a follow up of 24 month: Visual analogue scale (VAS)
timeFrame: 24 month
measure: Peri- und postoperative morbidity
timeFrame: 30 days, 6 and 24 month
measure: Mortality
timeFrame: 30 days, 6 and 24 month
measure: Coexisting characteristics of irritable bowel syndrome (IBS)
timeFrame: 0, 6 and 24 month
measure: Subjective assessment of Diverticulitis severity
timeFrame: 0, 6 and 24 month
measure: Diverticulitis severity: Classification of Diverticular Disease
timeFrame: 1 day before surgery
measure: Diverticulitis severity: Ambrossetti Classification
timeFrame: 1 day before surgery
measure: Diverticulitis severity: Modified Hinchey Classification
timeFrame: 1 day before surgery
measure: Diverticulitis severity according to preoperative CT-scan
timeFrame: 1 day before surgery
measure: Diverticulitis severity according to preoperative CT-scan
timeFrame: 1 day before surgery
measure: Diverticulitis severity
timeFrame: 2 days after surgery
measure: Influence of guideline specific treatment on postoperative quality of life
timeFrame: 6 and 24 month
measure: Postoperative changes in fecal continence
timeFrame: 0, 6 and 24 month
measure: Postoperative changes in urinary continence
timeFrame: 0, 6 and 24 month
measure: Postoperative changes in male sexual function
timeFrame: 0, 6 and 24 month
measure: Postoperative changes in female sexual function
timeFrame: 0, 6 and 24 month
measure: Preoperative fecal calprotectin
timeFrame: 1 day preoperative
measure: Postoperative fecal calprotectin
timeFrame: 6 and 24 month
measure: Morphological changes of the bowel wall
timeFrame: 1 day after surgery
measure: Morphological changes of the bowel wall: thickness of bowel wall
timeFrame: 1 day after surgery
measure: Morphological changes of the bowel wall: Cells of Cajal
timeFrame: 1 day after surgery
measure: Morphological changes of the bowel wall: Fibrosis
timeFrame: 1 day after surgery
measure: Cost analysis
timeFrame: baseline and 6 and 24 month
measure: Productivity analysis
timeFrame: baseline and 6 and 24 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik für Allgemein- Viszeral-, Endokrine- und Minimalinvasive Chirurgie, Klinikum Bogenhausen, Städtisches Klinikum München GmbH
state: Bavaria
Study officials:
affiliation: Städtisches Klinikum München GmbH
name: Maximilian Sohn, Dr. med.
role: STUDY_DIRECTOR
References:
citation: Sohn M, Agha A, Iesalnieks I, Bremer S, Trum S, Di Cerbo F, Nerlich A, Lotz N, Klieser E, Hochrein A, Schredl P, Kalcheva D, Emmanuel K, Presl J. PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study. BMJ Open. 2020 Mar 24;10(3):e034385. doi: 10.1136/bmjopen-2019-034385.