Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer. (ISR-TME)

Mansoura University

Status and phase: Unknown; Phase 2

Conditions: Low Rectal Cancer

Treatments: Procedure: open intersphincteric resection; Procedure: laparoscopic intersphincteric resection

Study type: Interventional

Funder types: Other

Identifiers

NCT02468362

ISR-TME

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Laparoscopic group

Active Comparator group

Treatment:

Procedure: laparoscopic intersphincteric resection

Open group

Active Comparator group

Treatment:

Procedure: open intersphincteric resection