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Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer

NCT ID: NCT02252250

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-11-30

Brief Summary

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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

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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.

Conditions

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Rectal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional laparoscopic

conventional laparoscopic total mesentery excision surgery for rectal cancer.

Group Type ACTIVE_COMPARATOR

conventional laparoscopic total mesentery excision

Intervention Type PROCEDURE

conventional laparoscopic total mesentery excision

Transanal hybrid-laparoscopic

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

Group Type EXPERIMENTAL

transanal hybrid-laparoscopic total mesentery excision

Intervention Type PROCEDURE

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.

Interventions

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conventional laparoscopic total mesentery excision

conventional laparoscopic total mesentery excision

Intervention Type PROCEDURE

transanal hybrid-laparoscopic total mesentery excision

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.

Intervention Type PROCEDURE

Other Intervention Names

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LTME TLTME

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weidong Tong

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weidong Tong, Prof

Role: PRINCIPAL_INVESTIGATOR

Daping Hospital, Third Military Medical University

Locations

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Daping hospital

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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20141056

Identifier Type: -

Identifier Source: org_study_id