Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer
MansTaTME
(MansTaTME) Trans-anal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is designed to assess the surgical, oncological and functional outcome of either the laparoscopic or trans-anal TME in management of mid and low rectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 25, 2017
CompletedFirst Submitted
Initial submission to the registry
August 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedAugust 8, 2017
August 1, 2017
1.7 years
August 1, 2017
August 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Circumferential radial margin (CRM)
Percentage of participants with involved circumferential margin(pathological assessment)
2 years
Distal safety margin
Distance of free distal margin in mm (pathological assessment)
2 years
Number of lymph nodes retrieved
Number of infiltrated/ Number of harvested lymph nodes(pathological assessment)
2 years
Secondary Outcomes (4)
Morbidity rate
2 years
Rate of conversion
2 years
Disease free survival
30 months
Functional outcome
18 months
Study Arms (2)
Trans-anal TME (TaTME)
EXPERIMENTALTrans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)
Lap. TME
ACTIVE COMPARATORLaparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
Interventions
Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)
Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
Eligibility Criteria
You may qualify if:
- Anesthetically fit patient.
- Non metastatic pathologically proven rectal cancer (Mid-Low).
- Patients who received neoadjuvant chemo-radiotherapy will be included
You may not qualify if:
- Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
- Patients with cardiac or chest problems that cannot withstand CO2 insufflation.
- Unresectable tumors (T4) (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).
- Obstructed or perforated cancer.
- Patients with unresectable metastatic rectal cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oncology Center, Mansoura University
Al Mansurah, Egypt
Related Publications (6)
Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.
PMID: 24225001BACKGROUNDVennix S, Pelzers L, Bouvy N, Beets GL, Pierie JP, Wiggers T, Breukink S. Laparoscopic versus open total mesorectal excision for rectal cancer. Cochrane Database Syst Rev. 2014 Apr 15;2014(4):CD005200. doi: 10.1002/14651858.CD005200.pub3.
PMID: 24737031BACKGROUNDQu C, Yuan RF, Huang J, Liu L, Jiang CH, Yang ZQ, Shao JH. [Meta-analysis of laparoscopic versus open total mesorectal excision for middle and low rectal cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2013 Aug;16(8):748-52. Chinese.
PMID: 23980046BACKGROUNDDeijen CL, Velthuis S, Tsai A, Mavroveli S, de Lange-de Klerk ES, Sietses C, Tuynman JB, Lacy AM, Hanna GB, Bonjer HJ. COLOR III: a multicentre randomised clinical trial comparing transanal TME versus laparoscopic TME for mid and low rectal cancer. Surg Endosc. 2016 Aug;30(8):3210-5. doi: 10.1007/s00464-015-4615-x. Epub 2015 Nov 4.
PMID: 26537907BACKGROUNDAtallah S, Martin-Perez B, Albert M, deBeche-Adams T, Nassif G, Hunter L, Larach S. Transanal minimally invasive surgery for total mesorectal excision (TAMIS-TME): results and experience with the first 20 patients undergoing curative-intent rectal cancer surgery at a single institution. Tech Coloproctol. 2014 May;18(5):473-80. doi: 10.1007/s10151-013-1095-7. Epub 2013 Nov 23.
PMID: 24272607BACKGROUNDSimillis C, Hompes R, Penna M, Rasheed S, Tekkis PP. A systematic review of transanal total mesorectal excision: is this the future of rectal cancer surgery? Colorectal Dis. 2016 Jan;18(1):19-36. doi: 10.1111/codi.13151.
PMID: 26466751BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
August 1, 2017
First Posted
August 8, 2017
Study Start
May 25, 2017
Primary Completion
January 25, 2019
Study Completion
December 30, 2019
Last Updated
August 8, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share