An observational study in Rectal Cancer, sponsored by University Hospital, Basel, Switzerland. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-10.
Sponsored by University Hospital, Basel, Switzerland · Observational
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.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's enrollment of 5 is below the median of 156 across 421 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →University Hospital, Basel, Switzerland is the lead sponsor of 989 studies on the registry; 191 are open to participants now.
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Patients with newly diagnosed rectal cancer
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Exclusion Criteria:
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 · Behavioral: Quality of Life Questionnaire · Behavioral: 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.
Behavioral: Quality of Life Questionnaire for gastrointestinal tract · Behavioral: Quality of Life Questionnaire · Behavioral: Faecal Incontinence Score
To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
Also known as: GIQLI questionnaire
To assess quality of life, the SF-36 questionnaire will be applied
Also known as: SF-36 questionnaire
To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
Also known as: Vaizey Wexner questionnaire
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
Plan to share: No
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Ran from Mar 2018 to primary completion in Mar 2020, 24 months.
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This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →