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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03487484
• Other study ID #: QoL Rectal Cancer
• Status: Terminated
• Start date: March 22, 2018
• Est. completion date: March 22, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 22, 2020
• Est. primary completion date: March 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Behavioral:
• Quality of Life Questionnaire for gastrointestinal tract
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
• Quality of Life Questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
• Faecal Incontinence Score
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied

Locations

Country	Name	City	State
Switzerland	St Claraspital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life specific for the gastrointestinal tract	GIQLI Score	at Baseline and up to 12 months after surgery
Secondary	Change in quality of life	Short Form (SF) 36	at Baseline and up to 12 months after surgery
Secondary	Change in faecal Incontinence	Vaizey Wexner Score	at Baseline and up to 12 months after surgery