Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma

April 8, 2020 updated by: University Hospital, Basel, Switzerland

Quality of Life in Patients With Rectal Cancer Receiving Neoadjuvant Chemotherapy, Total Mesorectal Excision With or Without Stoma and Adjuvant Chemotherapy: a Prospective, Single-centre Pilot-study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with newly diagnosed rectal cancer

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 tract
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
Other Names:
  • GIQLI questionnaire
Behavioral: Quality of Life Questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
Other Names:
  • SF-36 questionnaire
Behavioral: Faecal Incontinence Score
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
Other Names:
  • Vaizey Wexner questionnaire
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 tract
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
Other Names:
  • GIQLI questionnaire
Behavioral: Quality of Life Questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
Other Names:
  • SF-36 questionnaire
Behavioral: Faecal Incontinence Score
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
Other Names:
  • Vaizey Wexner questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life specific for the gastrointestinal tract
Time Frame: at Baseline and up to 12 months after surgery
GIQLI Score
at Baseline and up to 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: at Baseline and up to 12 months after surgery
Short Form (SF) 36
at Baseline and up to 12 months after surgery
Change in faecal Incontinence
Time Frame: at Baseline and up to 12 months after surgery
Vaizey Wexner Score
at Baseline and up to 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Susanne Drews, MD, Claraspital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2018

Primary Completion (Actual)

March 22, 2020

Study Completion (Actual)

March 22, 2020

Study Registration Dates

First Submitted

March 26, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QoL Rectal Cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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