NCT03527706

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

6.9 years

First QC Date

April 19, 2018

Last Update Submit

September 7, 2023

Conditions

Diverticular Disease of ColonQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (28)

  • Postoperative quality of life (QoL) after a follow up of six month: SF36

    six month

  • Postoperative quality of life (QoL) after a follow up of six month: Visual analogue scale (VAS)

    six month

  • Quality of life after a follow up of 24 month: SF-36

    24 month

  • Quality of life after a follow up of 24 month: GI-Quality of Life Index

    24 month

  • Quality of life after a follow up of 24 month: Visual analogue scale (VAS)

    24 month

  • +23 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients \> 18 years, matching to inclusion and exclusion criteria, who are scheduled for elective sigmoidectomy for diverticular disease

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 81925, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32209628DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The resected part of the bowel is histopathologically examinated and stored routinely for all patients (participants of the study as well as not participating patients)

MeSH Terms

Conditions

Diverticulosis, Colonic

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Maximilian Sohn, Dr. med.

    Städtisches Klinikum München GmbH

    STUDY DIRECTOR

Central Study Contacts

Maximilian Sohn, Dr. med.

CONTACT

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

Francesca Di Cerbo, Dr. med.

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med., Attending

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 17, 2018

Study Start

November 28, 2017

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

DE(1)