Outcomes of TAMIS-Total Mesorectal Excision Versus Transanal Loco-regional Excision for T2 Low Rectal Cancer

Low Rectal Cancer Clinical Trial

— TAMIS  

Official title:

Outcomes Comparison of TAMIS-TME Versus Transanal Minimally Invasive Locoregional Resection for T2 Low Rectal Cancer: an Open Label Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02488577
• Other study ID #: MISS-TRICKR2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 2015
• Est. completion date: October 2019

Study information

• Verified date: September 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cases with stage T2 N0 low rectal cancer will undergo either Transanal minimally invasive total mesorectal excision or transanal minimally invasive locoregional resection.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: October 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• T2 N0 low rectal cancer

Exclusion Criteria:

• patients unfit for laparoscopic resection

• Unwilling to share in the study

Related Conditions & MeSH terms

• Low Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Transanal minimally invasive total mesorectal excision

• transanal minimally invasive locoregional resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Osama Mohammad Ali ElDamshety

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall percent of postoperative complications.	the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.	30 days
Secondary	Hospital stay	Number of Days starting from the admission till discharge	30 days
Secondary	Recurrence.	number of local and distant recurrence	2 years