Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

NCT ID: NCT05682794

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2502 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2022-10-31

Brief Summary

The purpose of this study was to compare the long-term oncology outcomes and specimen quality of taTME and laTME in the treatment of middle and low rectal cancer by a large sample cohort. At the same time, the local recurrence following a primary rectal cancer resection was analyzed to respond to the concerns about the event of the national suspension for TaTME due to the high local recurrence rate in Norway.

Detailed Description

Laparoscopic surgery is considered to have better visualization for more accurate separation and further injury reduction than open surgery. However, the oncology outcomes are still controversial. Especially in the challenging patients who have narrow and deep pelvic, the disadvantage that it is difficult to obtain high-quality resected specimens during laparoscopic TME (laTME) surgery is considered to be magnified. It is considered transanal total mesorectal excision (taTME) is an alternative method to solve this "old problem". However, as a new technology that has been around for only 10 years, the applicability of taTME worldwide needs to be further proved in long-term oncology. This prospective cohort study aimed to compare taTME surgery to laTME surgery for mid and low-rectal cancer on long-term oncology outcomes from a single, experienced Chinese center that was an early adopter of taTME.

Conditions

Rectal Cancer

Study Design

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

Study Groups

taTME

patients who underwent transanal total mesorectal excision

transanal total mesorectal excision

Intervention Type: PROCEDURE

transanal TME

laTME

patients who underwent laparoscopic total mesorectal excision

No interventions assigned to this group

Interventions

transanal total mesorectal excision

transanal TME

Intervention Type: PROCEDURE

Other Intervention Names

laparoscopic total mesorectal excision

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 80 years old

2. Confirmed rectal adenocarcinoma cancer pathologically

3. Tumor location ≦ 12 cm from the anal margin

4. Willing and able to provide written informed consent for participation in this study

Exclusion Criteria

1. Distant metastasis before surgery

2. More than one colorectal tumor at diagnosis

3. Familial adenomatous polyposis

4. Recurrent rectal cancer

5. Undergo transanal minimally invasive surgery

6. Undergo palliative treatment

7. Undergo emergency surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Deng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang Kang

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

References

Li Z, Liu H, Luo S, Hou Y, Zhou Y, Zheng X, Zhang X, Huang L, Zeng Z, Kang L. Long-term oncological outcomes of transanal versus laparoscopic total mesorectal excision for mid-low rectal cancer: a retrospective analysis of 2502 patients. Int J Surg. 2024 Mar 1;110(3):1611-1619. doi: 10.1097/JS9.0000000000000992.

Reference Type: DERIVED

PMID: 38091943 (View on PubMed)

Other Identifiers

GIHSYSU-32

Identifier Type: -

Identifier Source: org_study_id