- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02252250
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
November 23, 2023 updated by: Weidong Tong, Third Military Medical University
A Prospective Cohort Study of Transanal Laparoscopic Total Mesentery Excision Versus Conventional Laparoscopic Surgery for Rectal Cancer
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
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Chongqing, Chongqing, China, 400042
- Daping Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: conventional laparoscopic
conventional laparoscopic total mesentery excision surgery for rectal cancer.
|
conventional laparoscopic total mesentery excision
Other Names:
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Experimental: Transanal hybrid-laparoscopic
Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens.
Time Frame: 1-6 years
|
Lymph nodes number; rate of positive circumferential resection margin(CRM);
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1-6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of 30-day perioperative complications including intraoperative, and postoperative complications
Time Frame: 0-30 days
|
bleeding, injury of adjacent organs, ileus, leakage, infection
|
0-30 days
|
Incidence of long-term complications
Time Frame: 1-6 years
|
incision hernia,
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1-6 years
|
Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.
Time Frame: 1-6 years
|
overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate
|
1-6 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
defecating functional outcomes
Time Frame: 1-6 years
|
constipation score and incontinence score
|
1-6 years
|
sexual functional outcomes
Time Frame: 1-6 years
|
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)
|
1-6 years
|
Quality of life outcomes evaluation
Time Frame: 1-6 years
|
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)) .
|
1-6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Weidong Tong, Prof, Daping Hospital, Third Military Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2014
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 29, 2014
First Posted (Estimated)
September 30, 2014
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20141056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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