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

Terminated

• Conditions: Rectal Cancer
• Interventions: Behavioral: Quality of Life Questionnaire for gastrointestinal tract; Behavioral: Quality of Life Questionnaire; Behavioral: Faecal Incontinence Score

• Registration Number: NCT03487484
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 Timeline

• Study Start: 2018-03-22
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-04-03
• Study First Posted: 2018-04-04
• Primary Completion: 2020-03-22
• Study Completion: 2020-03-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-08
• Last Update Posted: 2020-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With protective stoma	Faecal Incontinence Score	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.
No stoma	Quality of Life Questionnaire for gastrointestinal tract	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.
No stoma	Quality of Life Questionnaire	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.
With protective stoma	Quality of Life Questionnaire for gastrointestinal tract	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.
No stoma	Faecal Incontinence Score	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.
With protective stoma	Quality of Life Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Change in quality of life specific for the gastrointestinal tract	at Baseline and up to 12 months after surgery	GIQLI Score

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	at Baseline and up to 12 months after surgery	Short Form (SF) 36
Change in faecal Incontinence	at Baseline and up to 12 months after surgery	Vaizey Wexner Score

Trial Locations

Locations (1)

St Claraspital; 🇨🇭 Basel, Switzerland