PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease

NCT ID: NCT03527706

Last Updated: 2023-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-28

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diverticular Disease of Colon Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Städtisches Klinikum München GmbH

OTHER

Sponsor Role lead

Responsible Party

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Dr. Maximilian Sohn

Dr. med., Attending

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maximilian Sohn, Dr. med.

Role: STUDY_DIRECTOR

Städtisches Klinikum München GmbH

Locations

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

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Maximilian Sohn, Dr. med.

Role: CONTACT

+49-89-9270702756

Francesca Di Cerbo, Dr. med.

Role: CONTACT

+49-89-92702017

Facility Contacts

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Maximilian Sohn, Dr. med.

Role: primary

+49-89-9270702756

Francesca Di Cerbo, Dr. med.

Role: backup

+49-89-92702017

References

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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.

Reference Type DERIVED
PMID: 32209628 (View on PubMed)

Other Identifiers

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PREDIC-DIV 1.0

Identifier Type: -

Identifier Source: org_study_id

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