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RecruitingNCT05201885Updated Feb 3, 2022

Oncological Differences Between Transanal and Laparoscopic Total Mesorectal Excision for Rectal Cancer.

An observational study in Rectum Cancer, sponsored by Yanhong Deng. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by Yanhong Deng · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2023, 3 years 8 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
192
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to compare the differences of oncological in rectal cancer patients undergoing laparoscopic or transanal endoscopy radical resection. The secondary purpose is to compare the effect of two different surgical methods on prognosis.

Read the detailed description

Transanal total mesorectal excision (taTME) is a new surgical procedure for total mesorectal excision (TME) by dissociating the mesorectum from the bottom through transanal endoscopic. The characteristics of TaTME are mainly summarized as transanal reverse operation, no auxiliary abdominal incision, complete mesorectal excision and specimen removal through the anus. So taTME is a natural orifice specimen extraction procedure (NOSES). However, similar to NOSES, the specific surgical approach to taTME surgery may raise oncological safety concerns. Due to the premature contact with the tumor, the squeezing of the tumor cannot be avoided during the operation. The tumor may also be squeezed when the specimen is removed through the anus, putting the tumor cells at risk of shedding into the abdominal and pelvic cavity.

Whether TaTME is safe and feasible still needs strong evidence-based medical evidence. However, there have been prospective studies related to oncological in NOSES surgery, but there is a lack of prospective clinical studies on the issue of oncological diffusion during taTME surgery. Therefore, the investigators conducted a randomized controlled study to collect the abdominal and pelvic irrigation fluids in the transanal and laparoscopic TME surgery for oncological examination, to clarify the influence of the two different surgical methods on the intraoperative oncological diffusion. The purpose of this study was to clarify the effect of two different surgical methods on intraoperative tumor cell proliferation, and to compare the long-term oncological outcomes of the two surgical methods, so as to provide more evidence-based medical evidence for the safety of taTME surgery.

02

Conditions studied

  • Rectum Cancer

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03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 192 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Yanhong Deng is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

192 rectal cancer patients will be enrolled. Patients must be older than 18 years.

Inclusion criteria

  • Primary rectal carcinoma
  • Single lesion
  • No metastasis

Exclusion criteria

Exclusion Criteria:

  • History of malignant tumors
  • Acute bowel obstruction, bleeding or perforation
  • Tumor over 6cm in diameter or in severe adhesion with surrounded tissues
  • Severe other contradictions of surgery
  • Pregnant women will be excluded
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
192 participants (estimated)
Patient registry
No

Groups and cohorts

  • laparoscopic surgery

    Different surgical methods for rectal cancer resection

  • Transanal endoscopic surgery

    Different surgical methods for rectal cancer resection

06

What researchers measure

Primary outcomes

  1. The positive rate of oncological contamination of peritoneal washings

    Determination of tumor cell positive rate by tumor cell examination of peritoneal washings

    Time frame: 1 years

Secondary outcomes

  1. Disease free survival

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong 510655, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05201885
Lead sponsor
Yanhong Deng
Responsible party
Yanhong Deng (Director, Sun Yat-sen University) — Sponsor-investigator
First posted
Jan 21, 2022
Start date
Jan 15, 2022
Primary completion
Feb 2023 (estimated)
Completion
Feb 2026 (estimated)
Last update
Feb 3, 2022

Study contacts

Liang Huang
Contact
huangl75@mail.sysu.edu.cn
15989101216
Mian Chen
Contact
chenmian1997@163.com
13711370070

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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