NCT03009747UnknownNot Applicable
A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 460
- Primary Endpoint
- Incidence of bowel dysfunction after sphincter-preserving surgery
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≤
- •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.
Outcomes
Primary Outcomes
Incidence of bowel dysfunction after sphincter-preserving surgery
Time Frame: one year
Risk factors of bowel dysfunction after sphincter-preserving surgery
Time Frame: one year
Secondary Outcomes
- 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(one year)
Investigators
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