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Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05682794
Enrollment
2502
Registered
2023-01-12
Start date
2014-01-31
Completion date
2022-10-31
Last updated
2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Rectal cancer, taTME, Local recurrence

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.

Interventions

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall survival rate5 years after the surgery
disease-free survival ratev5 years after the surgery

Secondary

MeasureTime frameDescription
Quality of the mesorectum specimen30 days after the surgeryThe quality of the resected mesorectum was classified into three grades: (a) incomplete, (b) nearly complete, and (c) complete
Local recurrence rate3 years after the surgeryLocal 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
DRM status30 days after the surgeryThe DRM was regarded as positive if it was microscopically involved by or ≦1 mm from the tumor margins.
CRM status30 days after the surgeryThe CRM was regarded as positive if the tumor distance or malignant lymph node to CRM was ≦1 mm.
Cancer special survival rate5 years after the surgeryCancer special survival was defined as the time from the date of primary rectal cancer resection to the date of death caused by rectal cancer.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026