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

Sponsor

Osama Mohammad Ali ElDamshety (Other)

Overall Status

Unknown status

CT.gov ID

NCT02488577

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Low Rectal Cancer	Procedure: Transanal minimally invasive total mesorectal excision Procedure: transanal minimally invasive locoregional resection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TAMIS TME T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.	Procedure: Transanal minimally invasive total mesorectal excision
Active Comparator: TAMIS-Local T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.	Procedure: transanal minimally invasive locoregional resection

Arm

Intervention/Treatment

Active Comparator: TAMIS TME

T2 N0 Cases which undergo transanal minimally invasive total mesorectal excision.

Procedure: Transanal minimally invasive total mesorectal excision

Active Comparator: TAMIS-Local

T2 N0 Cases which will undergo transanal minimally invasive locoregional resection.

Procedure: transanal minimally invasive locoregional resection

Outcome Measures

Primary Outcome Measures

Overall percent of postoperative complications. [30 days]
the over all percentage of Postoperative complications concerning Pelvis abscess, anastomosis disruption, bleeding, Fistula and continence function.

Secondary Outcome Measures

Hospital stay [30 days]
Number of Days starting from the admission till discharge
Recurrence. [2 years]
number of local and distant recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

T2 N0 low rectal cancer

Exclusion Criteria:

patients unfit for laparoscopic resection
Unwilling to share in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Osama Mohammad Ali ElDamshety

Investigators

Study Director: Sherif Kotb, M.D., PhD., Professor of surgical oncology Mansoura university
Principal Investigator: Osama Eldamshety, PhD, surgical oncology Mansoura university
Principal Investigator: Adel Fathi, M.D., surgical oncology Mansoura university

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Osama Mohammad Ali ElDamshety, Assistant lecturer of surgical oncology., Mansoura University

ClinicalTrials.gov Identifier:

NCT02488577

Other Study ID Numbers:

MISS-TRICKR2

First Posted:

Jul 2, 2015

Last Update Posted:

Sep 12, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Rectal Neoplasms

Study Results

No Results Posted as of Sep 12, 2018