- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05201885
Oncological Differences Between Transanal and Laparoscopic Total Mesorectal Excision for Rectal Cancer.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Liang Huang
- Phone Number: 15989101216
- Email: huangl75@mail.sysu.edu.cn
Study Contact Backup
- Name: Mian Chen
- Phone Number: 13711370070
- Email: chenmian1997@163.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510655
- Recruiting
- Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
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Contact:
- Liang Huang, MD, PhD
- Phone Number: 15989101216
- Email: huangl75@mail.sysu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primary rectal carcinoma
- Single lesion
- No metastasis
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
laparoscopic surgery
Different surgical methods for rectal cancer resection
|
Transanal endoscopic surgery
Different surgical methods for rectal cancer resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The positive rate of oncological contamination of peritoneal washings
Time Frame: 1 years
|
Determination of tumor cell positive rate by tumor cell examination of peritoneal washings
|
1 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease free survival
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIHSYSU-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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