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

University Hospital Basel

Status: Terminated

Conditions: Rectal Cancer

Treatments: Behavioral: Faecal Incontinence Score; Behavioral: Quality of Life Questionnaire for gastrointestinal tract; Behavioral: Quality of Life Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT03487484

QoL Rectal Cancer

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 2 patient groups

With protective stoma

Description:

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.

Treatment:

Behavioral: Quality of Life Questionnaire

Behavioral: Quality of Life Questionnaire for gastrointestinal tract

Behavioral: Faecal Incontinence Score

No stoma

Description:

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.

Treatment:

Behavioral: Quality of Life Questionnaire

Behavioral: Quality of Life Questionnaire for gastrointestinal tract

Behavioral: Faecal Incontinence Score