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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05201872
Other study ID # GIHSYSU-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 15, 2022
Est. completion date April 2023

Study information

Verified date January 2022
Source Sun Yat-sen University
Contact Liang Huang
Phone 15989101216
Email huangl75@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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). Compared with traditional laparoscopy, taTME has obvious oncological and technical advantages. However, similar to NOSES, the specific surgical approach to taTME may induces bacteriological safety concerns. Whether TaTME is safe and feasible still needs strong evidence-based medical evidence. However, there have been prospective studies related to bacteriology in NOSES surgery, but there is a lack of prospective clinical studies on the issue of bacteriological diffusion during taTME surgery. Bacterial contamination of the peritoneal cavity is common in laparoscopic surgery for colorectal cancer. Although the standard NOSES procedure avoids bacteriological problems through the use of antibiotics, surgical peritoneal irrigation, and the use of sterile specimen bags, its safety remains inconclusive. Therefore, compared with conventional laparoscopic colorectal cancer surgery, taTME not only takes specimens from the natural orifice, but also requires further prospective studies on whether the incision of the intestinal wall from the mucosa during the operation will violate the aseptic principle, the aseptic safety of taTME still needs further prospective studies to confirm. Therefore, the investigators conducted a randomized controlled study to collect the abdominal and pelvic irrigation fluids in the transanal and laparoscopic TME surgery for bacteriological examination, to clarify the influence of the two different surgical methods on the intraoperative bacterial diffusion. The purpose of this study was to clarify the influence of two different surgical methods on the intraoperative bacterial spread, and to provide more evidence-based medical evidence for the safety of taTME surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 216
Est. completion date April 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Yanhong Deng

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The positive rate of bacterial contamination of peritoneal washings Bacterial contamination positive rate determined by bacterial culture of intra-operative peritoneal washings 1 years
Secondary Postoperative complications Determine whether patients have postoperative complications after surgery a month
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