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

Low Rectal Cancer Clinical Trial

— ISR-TME  

Official title:

Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02468362
• Other study ID #: ISR-TME
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: June 7, 2015
• Last updated: June 9, 2015
• Start date: April 2014
• Est. completion date: October 2019

Study information

• Verified date: June 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Surgical department board , Mansoura university
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 112
• Est. completion date: October 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• laparoscopic intersphincteric resection
laparoscopic intersphincteric resection for low rectal cancer
• open intersphincteric resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free survival		5 years	No
Secondary	Local recurrence		5 years	Yes
Secondary	Distant metstasis		5 years	Yes
Secondary	5 year survival		5 years	Yes