Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

Rectal Cancer Clinical Trial

Official title:

Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05682794
• Other study ID #: GIHSYSU-32
• Status: Completed
• Start date: January 2014
• Est. completion date: October 2022

Study information

• Verified date: December 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2502
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• transanal total mesorectal excision
transanal TME

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		5 years after the surgery
Primary	disease-free survival ratev		5 years after the surgery
Secondary	Local recurrence rate	Local recurrence was defined as radiologic or histopathologic evidence of any recurrent disease deposit located in the pelvis in the prior area of dissection following a primary rectal cancer resection, with or without distal metastasis	3 years after the surgery
Secondary	Cancer special survival rate	Cancer special survival was defined as the time from the date of primary rectal cancer resection to the date of death caused by rectal cancer.	5 years after the surgery
Secondary	Quality of the mesorectum specimen	The quality of the resected mesorectum was classified into three grades: (a) incomplete, (b) nearly complete, and (c) complete	30 days after the surgery
Secondary	CRM status	The CRM was regarded as positive if the tumor distance or malignant lymph node to CRM was ?1 mm.	30 days after the surgery
Secondary	DRM status	The DRM was regarded as positive if it was microscopically involved by or ?1 mm from the tumor margins.	30 days after the surgery