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Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

Primary Purpose

Rectal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
conventional laparoscopic total mesentery excision
transanal hybrid-laparoscopic total mesentery excision
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring rectal cancer, laparoscopic, taTME, TME

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy-proven adenocarcinoma of the rectum
  • Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma
  • Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI
  • Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI
  • Rectal cancer located 3-10 cm from the anal verge

Exclusion Criteria:

  • Metastasis
  • Obstructing rectal cancer
  • Synchronous colon cancer
  • T4 rectal cancer not treated preoperatively with full-course chemoradiation
  • Pregnant or breast-feeding
  • Receiving any other study agents
  • Fecal incontinence
  • History of prior colorectal cancer
  • History of inflammatory bowel disease
  • History of pelvic radiation
  • BMI > 40
  • Large uterine fibroids
  • Uncontrolled intercurrent illness

Sites / Locations

  • Daping hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional laparoscopic

Transanal hybrid-laparoscopic

Arm Description

conventional laparoscopic total mesentery excision surgery for rectal cancer.

Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.

Outcomes

Primary Outcome Measures

Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
Lymph nodes number; rate of positive circumferential resection margin(CRM);

Secondary Outcome Measures

Incidence of 30-day perioperative complications including intraoperative, and postoperative complications
bleeding, injury of adjacent organs, ileus, leakage, infection
Incidence of long-term complications
incision hernia,
Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.
overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate

Full Information

First Posted
September 23, 2014
Last Updated
April 24, 2022
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02252250
Brief Title
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
Official Title
A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Detailed Description
Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
rectal cancer, laparoscopic, taTME, TME

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional laparoscopic
Arm Type
Active Comparator
Arm Description
conventional laparoscopic total mesentery excision surgery for rectal cancer.
Arm Title
Transanal hybrid-laparoscopic
Arm Type
Experimental
Arm Description
Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.
Intervention Type
Procedure
Intervention Name(s)
conventional laparoscopic total mesentery excision
Other Intervention Name(s)
LTME
Intervention Description
conventional laparoscopic total mesentery excision
Intervention Type
Procedure
Intervention Name(s)
transanal hybrid-laparoscopic total mesentery excision
Other Intervention Name(s)
TLTME
Intervention Description
transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.
Primary Outcome Measure Information:
Title
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
Description
Lymph nodes number; rate of positive circumferential resection margin(CRM);
Time Frame
1-6 years
Secondary Outcome Measure Information:
Title
Incidence of 30-day perioperative complications including intraoperative, and postoperative complications
Description
bleeding, injury of adjacent organs, ileus, leakage, infection
Time Frame
0-30 days
Title
Incidence of long-term complications
Description
incision hernia,
Time Frame
1-6 years
Title
Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.
Description
overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate
Time Frame
1-6 years
Other Pre-specified Outcome Measures:
Title
defecating functional outcomes
Description
constipation score and incontinence score
Time Frame
1-6 years
Title
sexual functional outcomes
Description
We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF)
Time Frame
1-6 years
Title
Quality of life outcomes evaluation
Description
We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) .
Time Frame
1-6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-proven adenocarcinoma of the rectum Eligible to undergo conventional laparoscopic low anterior resection or transanal hybrid-laparoscopic low anterior resection with or without a temporary diverting stoma Node negative (N0), T1 (high risk features), T2 and T3 rectal cancer on pelvic MRI Closest distance between tumor edge and mesorectal fascia 5mm or more based on pelvic MRI Rectal cancer located 3-10 cm from the anal verge Exclusion Criteria: Metastasis Obstructing rectal cancer Synchronous colon cancer T4 rectal cancer not treated preoperatively with full-course chemoradiation Pregnant or breast-feeding Receiving any other study agents Fecal incontinence History of prior colorectal cancer History of inflammatory bowel disease History of pelvic radiation BMI > 40 Large uterine fibroids Uncontrolled intercurrent illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Tong, Prof
Phone
86-023-68757956
Email
tongweidong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Weidong Tong, Prof
Phone
86-13500321218
Email
vdtong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weidong Tong, Prof
Organizational Affiliation
Daping Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Tong, Prof
Phone
86-023-68757956
Email
tongweidong@gmail.com
First Name & Middle Initial & Last Name & Degree
Weidong Tong, Prof
Phone
86-13500321218
Email
vdtong@163.com

12. IPD Sharing Statement

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Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

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