A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery

Study Overview
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Brief Summary
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This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.

Official Title
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A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation

Conditions
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Bowel Dysfunction, Rectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Adenocarcinoma confirmed by pathology Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope. The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT). The operation is estimated to be sphincter-preserving. The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is ≤ 2. The estimated life time is not less than one year. The patient agree to sign the informed consent. Exclusion Criteria: The patient refuse to follow research plan. Emergency case Pregnant and lactating female patient The patient did not accept radical resection. The patient did not accept first stage resection and anastomosis. The patient has experienced anal-rectal surgery. The patient has experienced left colon surgery. The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis. The patient was diagnosed with cognitive or communicative obstacles. The patient was diagnosed with serious repeated infection or other concomitance diseases. The patient has participated other medical research which may affect his/her bowel function.

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 |
| --- | --- |
| sphincter-preserving surgery<br>Patients meet the inclusion criteria will be enrolled into this observing group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bowel dysfunction after sphincter-preserving surgery |  | one year | 
| Risk factors of bowel dysfunction after sphincter-preserving surgery |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of each symptoms of bowel dysfunction |  | one year | 
| Prognosis of bowel dysfunction after sphincter-preserving surgery |  | one year | 
| Incidence of bowel dysfunction after sphincter-preserving surgery | comparing incidences between high and low anastomsis site | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, anterior resection syndrome, sphincter-preserving surgery