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insufficient recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With protective stoma | 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. |
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| No stoma | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of Life Questionnaire for gastrointestinal tract | Behavioral | To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life specific for the gastrointestinal tract | GIQLI Score | at Baseline and up to 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Short Form (SF) 36 | at Baseline and up to 12 months after surgery |
| Change in faecal Incontinence | Vaizey Wexner Score |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with newly diagnosed rectal cancer
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Drews, MD | Claraspital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Claraspital | Basel | 4058 | Switzerland |
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| Quality of Life Questionnaire | Behavioral | To assess quality of life, the SF-36 questionnaire will be applied |
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| Faecal Incontinence Score | Behavioral | To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied |
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| at Baseline and up to 12 months after surgery |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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