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

• Sponsor: Mansoura University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02468362
• Collaborator: (none)
• Enrollment: 112
• Arms: 2
• Duration (Months): 66

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Rectal Cancer	Procedure: laparoscopic intersphincteric resection; Procedure: open intersphincteric resection	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 112 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial
• Study Start Date: Apr 1, 2014
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laparoscopic group	Procedure: laparoscopic intersphincteric resection; laparoscopic intersphincteric resection for low rectal cancer
Active Comparator: Open group	Procedure: open intersphincteric resection

Outcome Measures

Primary Outcome Measures

1. Disease Free survival [5 years]

Secondary Outcome Measures

1. Local recurrence [5 years]

2. Distant metstasis [5 years]

3. 5 year survival [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: Osama Eldamshety, PhD, MD, Oncology centre of mansoura university
• Principal Investigator: Sherif Kotb, PhD, MD, Oncology centre of mansoura university
• Principal Investigator: Nazem Shams, PhD, MD, Oncology centre of mansoura university
• Principal Investigator: Ashraf Khater, Phd, MD, Oncology centre of mansoura university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Osama Mohammad Ali ElDamshety, surgical oncology, Mansoura University
• ClinicalTrials.gov Identifier: NCT02468362
• Other Study ID Numbers: ISR-TME
• First Posted: Jun 10, 2015
• Last Update Posted: Jun 10, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Osama Mohammad Ali ElDamshety, surgical oncology, Mansoura University: Intersphincteric resection; laparoscopic rectal rescetion; total mesorectal excsison
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jun 10, 2015