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PREDICtors for Quality of Life After Sigmoidectomy for DIVerticular Disease (PREDIC-DIV)

S

Städtisches Klinikum München GmbH

Status

Enrolling

Conditions

Quality of Life
Diverticular Disease of Colon

Study type

Observational

Funder types

Other

Identifiers

NCT03527706
PREDIC-DIV 1.0

Details and patient eligibility

About

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

Full 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.

Enrollment

165 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Francesca Di Cerbo, Dr. med.; Maximilian Sohn, Dr. med.

Data sourced from clinicaltrials.gov

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