NCT02252250

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

September 23, 2014

Last Update Submit

November 23, 2023

Conditions

Rectal Neoplasms

Keywords

rectal cancerlaparoscopictaTMETME

Outcome Measures

Primary Outcomes (1)

  • 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);

    1-6 years

Secondary Outcomes (3)

  • Incidence of 30-day perioperative complications including intraoperative, and postoperative complications

    0-30 days

  • Incidence of long-term complications

    1-6 years

  • Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision.

    1-6 years

Other Outcomes (3)

  • defecating functional outcomes

    1-6 years

  • sexual functional outcomes

    1-6 years

  • Quality of life outcomes evaluation

    1-6 years

Study Arms (2)

conventional laparoscopic

ACTIVE COMPARATOR

conventional laparoscopic total mesentery excision surgery for rectal cancer.

Procedure: conventional laparoscopic total mesentery excision

Transanal hybrid-laparoscopic

EXPERIMENTAL

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

Procedure: transanal hybrid-laparoscopic total mesentery excision

Interventions

conventional laparoscopic total mesentery excisionPROCEDURE

conventional laparoscopic total mesentery excision

Also known as: LTME
conventional laparoscopic
transanal hybrid-laparoscopic total mesentery excisionPROCEDURE

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.

Also known as: TLTME
Transanal hybrid-laparoscopic

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping hospital

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Weidong Tong, Prof

    Daping Hospital, Third Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 23, 2014

First Posted

September 30, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2019

Study Completion

November 1, 2020

Last Updated

November 27, 2023

Record last verified: 2023-11

Locations

CN(1)