NCT02468362UnknownPhase 2
Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Mansoura University
- Enrollment
- 112
- Primary Endpoint
- Disease Free survival
Study Overview
Brief Summary
Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Low rectal cancer below 5 cm from the anal verge
- •Fit for laparoscopic total mesorectal excsion
- •T2, T3 rectal cancer
- •No distant metstasis
Exclusion Criteria
- •T1, AND T4
- •Distant metastasis
- •Tumor infiltrating the dentate line
- •unwilling to participate
Arms & Interventions
Laparoscopic group
Active Comparator
Intervention: laparoscopic intersphincteric resection (Procedure)
Open group
Active Comparator
Intervention: open intersphincteric resection (Procedure)
Outcomes
Primary Outcomes
Disease Free survival
Time Frame: 5 years
Secondary Outcomes
- Local recurrence(5 years)
- 5 year survival(5 years)
- Distant metstasis(5 years)
Investigators
Osama Mohammad Ali ElDamshety
surgical oncology
Mansoura University
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