NCT03487484

Brief Summary

The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

March 22, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

March 26, 2018

Last Update Submit

April 8, 2020

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life specific for the gastrointestinal tract

    GIQLI Score

    at Baseline and up to 12 months after surgery

Secondary Outcomes (2)

  • Change in quality of life

    at Baseline and up to 12 months after surgery

  • Change in faecal Incontinence

    at Baseline and up to 12 months after surgery

Study Arms (2)

With protective stoma

Patients in which intraoperatively the decision was made to add a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the Gastrointestinal Quality of Life Index (GIQLI) questionnaire, Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied.

Behavioral: Quality of Life Questionnaire for gastrointestinal tractBehavioral: Quality of Life QuestionnaireBehavioral: Faecal Incontinence Score

No stoma

Patients in which intraoperatively the decision was made to refrain from adding a protective stoma (following a risk algorithm) to total mesorectal excision. In patients quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index), Quality of Life Questionnaire for gastrointestinal tract and Faecal Incontinence Score will be applied.

Behavioral: Quality of Life Questionnaire for gastrointestinal tractBehavioral: Quality of Life QuestionnaireBehavioral: Faecal Incontinence Score

Interventions

Quality of Life Questionnaire for gastrointestinal tractBEHAVIORAL

To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied

Also known as: GIQLI questionnaire
No stomaWith protective stoma
Quality of Life QuestionnaireBEHAVIORAL

To assess quality of life, the SF-36 questionnaire will be applied

Also known as: SF-36 questionnaire
No stomaWith protective stoma
Faecal Incontinence ScoreBEHAVIORAL

To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied

Also known as: Vaizey Wexner questionnaire
No stomaWith protective stoma

Eligibility Criteria

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

Patients with newly diagnosed rectal cancer

You may qualify if:

  • age older than 18,
  • low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
  • German speaking patient who is capable to fill in the questionnaire,
  • signed informed consent

You may not qualify if:

  • age younger than 18,
  • preoperative stoma,
  • not German speaking
  • inability to fill in the questionnaire,
  • no standardized chemo- and radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Claraspital

Basel, 4058, Switzerland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Susanne Drews, MD

    Claraspital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 4, 2018

Study Start

March 22, 2018

Primary Completion

March 22, 2020

Study Completion

March 22, 2020

Last Updated

April 10, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)