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.
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
5
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
To assess quality of life, the SF-36 questionnaire will be applied
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
St Claraspital
Basel, Switzerland
Change in quality of life specific for the gastrointestinal tract
GIQLI Score
Time frame: at Baseline and up to 12 months after surgery
Change in quality of life
Short Form (SF) 36
Time frame: at Baseline and up to 12 months after surgery
Change in faecal Incontinence
Vaizey Wexner Score
Time frame: at Baseline and up to 12 months after surgery
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