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Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer (MansTaTME)

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Trans-anal total mesorectal excision(TaTME)
Lap. TME
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Minimally invasive surgery, trans-anal total mesorectal excision, Laparoscopic total mesoretal excision

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Anesthetically fit patient.
  2. Non metastatic pathologically proven rectal cancer (Mid-Low).
  3. Patients who received neoadjuvant chemo-radiotherapy will be included

Exclusion Criteria:

  1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5.
  2. Patients with cardiac or chest problems that cannot withstand CO2 insufflation.
  3. 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).
  4. Obstructed or perforated cancer.
  5. Patients with unresectable metastatic rectal cancer.

Sites / Locations

  • Oncology Center, Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trans-anal TME (TaTME)

Lap. TME

Arm Description

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

Outcomes

Primary Outcome Measures

Circumferential radial margin (CRM)
Percentage of participants with involved circumferential margin(pathological assessment)
Distal safety margin
Distance of free distal margin in mm (pathological assessment)
Number of lymph nodes retrieved
Number of infiltrated/ Number of harvested lymph nodes(pathological assessment)

Secondary Outcome Measures

Morbidity rate
Number of intra-operative and post-operative encountered complications
Rate of conversion
Percentage of conversion to open technique or to laparoscopy in TaTME cases or open in lap. cases
Disease free survival
Time till development of local or distant recurrence in months
Functional outcome
Assessment of functional outcome via questionnaires

Full Information

First Posted
August 1, 2017
Last Updated
August 3, 2017
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03242187
Brief Title
Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer
Acronym
MansTaTME
Official Title
(MansTaTME) Trans-anal Versus Laparoscopic Total Mesorectal Excision for Mid and Low Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
January 25, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Colorectal cancer (CRC) is considered the third most common type of cancer all over the world and the fourth common cause of cancer-specific mortality.Surgical management for rectal cancer is challenging due to the narrow pelvis and extreme proximity to contiguous organs hence, recurrence rates are commonly reported. The advent of total mesorectal excision (TME) together with minimally invasive techniques such as laparoscopic colorectal surgery have not only improved surgical results but have also improved surgical technique, operative ability and surgical visibility. Lap TME has been shown to give similar results to the classical open approach with regard to peri-operative morbidity, surgical margins, quality of the surgical specimen, and number of resected lymph nodes, local recurrence and overall survival. However, laparoscopic resection of mid and low rectal cancer is technically difficult due to tapering of the mesorectum in the pelvis and the forward angle of the distal rectum rendering this part of the rectum less accessible from the abdominal cavity. This may lead to incomplete mesorectal excision and involved circumferential resection margins (CRMs), with consequent local recurrences.Previous pelvic radiation can make laparoscopic pelvic dissection more difficult, and tumors located on the anterior rectal wall have an increased risk of inadequate oncological clearance. The use of laparoscopic staplers in a narrow pelvis is difficult and the multiple firings of staples across the low rectum is of concern. Trans-anal Total Mesorectal Excision (TaTME) was recently developed to overcome technical difficulties associated with Lap TME and open TME. It may address some of the difficult aspects of laparoscopic or open TME, such as exposure, rectal dissection, and distal cross-stapling of the rectum and sphincter preservation. It does not only facilitate dissection of the difficult distal part of the TME dissection in the narrow pelvis but it also allows clear definition of safe, tumor-free, radial and longitudinal margins. Moreover, the specimen could be extracted through the anus excluding the need for minilaparotmy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Minimally invasive surgery, trans-anal total mesorectal excision, Laparoscopic total mesoretal excision

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trans-anal TME (TaTME)
Arm Type
Experimental
Arm Description
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)
Arm Title
Lap. TME
Arm Type
Active Comparator
Arm Description
Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
Intervention Type
Procedure
Intervention Name(s)
Trans-anal total mesorectal excision(TaTME)
Other Intervention Name(s)
Bottom to up approach
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Lap. TME
Intervention Description
Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
Primary Outcome Measure Information:
Title
Circumferential radial margin (CRM)
Description
Percentage of participants with involved circumferential margin(pathological assessment)
Time Frame
2 years
Title
Distal safety margin
Description
Distance of free distal margin in mm (pathological assessment)
Time Frame
2 years
Title
Number of lymph nodes retrieved
Description
Number of infiltrated/ Number of harvested lymph nodes(pathological assessment)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Morbidity rate
Description
Number of intra-operative and post-operative encountered complications
Time Frame
2 years
Title
Rate of conversion
Description
Percentage of conversion to open technique or to laparoscopy in TaTME cases or open in lap. cases
Time Frame
2 years
Title
Disease free survival
Description
Time till development of local or distant recurrence in months
Time Frame
30 months
Title
Functional outcome
Description
Assessment of functional outcome via questionnaires
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anesthetically fit patient. Non metastatic pathologically proven rectal cancer (Mid-Low). Patients who received neoadjuvant chemo-radiotherapy will be included Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Z Metwally, Ass.Lecturer
Phone
00201068683363
Email
mohammadzuhdy@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh R Abdelazeez, Professor
Email
samehroshdy20@gmail.com
Facility Information:
Facility Name
Oncology Center, Mansoura University
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Z Metwally, Ass.Lecturer
Phone
00201068683363
Email
mohammadzuhdy@gmail.com
First Name & Middle Initial & Last Name & Degree
Sameh R Abdelaziz, Professor
Email
samehroshdy20@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24225001
Citation
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.
Results Reference
background
PubMed Identifier
24737031
Citation
Vennix 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;(4):CD005200. doi: 10.1002/14651858.CD005200.pub3.
Results Reference
background
PubMed Identifier
23980046
Citation
Qu 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.
Results Reference
background
PubMed Identifier
26537907
Citation
Deijen 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.
Results Reference
background
PubMed Identifier
24272607
Citation
Atallah 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.
Results Reference
background
PubMed Identifier
26466751
Citation
Simillis 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.
Results Reference
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Trans-anal Versus Laparoscopic TME for Mid and Low Rectal Cancer

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