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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectum Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 216

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

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Liang Huang, MD, PhD; Phone Number: 15989101216; Email: huangl75@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

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?

Number of groups / cohorts

2

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 bacterial contamination of peritoneal washings	Bacterial contamination positive rate determined by bacterial culture of intra-operative peritoneal washings	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Determine whether patients have postoperative complications after surgery	a month

Collaborators and Investigators

• Sponsor: Yanhong Deng

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: GIHSYSU-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No