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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Behavioral: Quality of Life Questionnaire for gastrointestinal tract
* Behavioral: Quality of Life Questionnaire
* Behavioral: Faecal Incontinence Score


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With protective stoma<br>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<br>* To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied<br>* Other names: GIQLI questionnaire;Behavioral: Quality of Life Questionnaire<br>* To assess quality of life, the SF-36 questionnaire will be applied<br>* Other names: SF-36 questionnaire;Behavioral: Faecal Incontinence Score<br>* To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied<br>* Other names: Vaizey Wexner questionnaire;|
| No stoma<br>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<br>* To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied<br>* Other names: GIQLI questionnaire;Behavioral: Quality of Life Questionnaire<br>* To assess quality of life, the SF-36 questionnaire will be applied<br>* Other names: SF-36 questionnaire;Behavioral: Faecal Incontinence Score<br>* To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied<br>* Other names: Vaizey Wexner questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | at Baseline and up to 12 months after surgery |