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

NCT ID: NCT05201872

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 216 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-04-30

Brief 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.

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). 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.

Conditions

Rectum Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

laparoscopic surgery

Different surgical methods for rectal cancer resection

No interventions assigned to this group

Transanal endoscopic surgery

Different surgical methods for rectal cancer resection

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanhong Deng

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Deng

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Huang

Role: CONTACT

huangl75@mail.sysu.edu.cn

15989101216

Mian Chen

Role: CONTACT

chenmian1997@163.com

13711370070

Facility Contacts

Liang Huang, MD, PhD

Role: primary

huangl75@mail.sysu.edu.cn

15989101216

Other Identifiers

GIHSYSU-21

Identifier Type: -

Identifier Source: org_study_id