Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.

Phase 2

• Conditions: Low Rectal Cancer
• Interventions: Procedure: open intersphincteric resection; Procedure: laparoscopic intersphincteric resection

• Registration Number: NCT02468362
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Status Verified: 2015-06
• Study First Submitted: 2015-06-07
• Study First Submitted QC: 2015-06-09
• Last Update Submitted: 2015-06-09
• Study First Posted: 2015-06-10
• Last Update Posted: 2015-06-10
• Primary Completion: 2019-04
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open group	open intersphincteric resection	-
Laparoscopic group	laparoscopic intersphincteric resection	-

Primary Outcome Measures

Name	Time	Method
Disease Free survival	5 years

Secondary Outcome Measures

Name	Time	Method
5 year survival	5 years
Distant metstasis	5 years
Local recurrence	5 years