Clinical trial NCT05682794: Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort
Official title: Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal cancer
taTME
Local recurrence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 2502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low-mid rectal cancer within Stage III.

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.

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

Primary outcomes:
measure: Overall survival rate
timeFrame: 5 years after the surgery
measure: disease-free survival ratev
timeFrame: 5 years after the surgery
Secondary outcomes:
measure: Local recurrence rate
timeFrame: 3 years after the surgery
measure: Cancer special survival rate
timeFrame: 5 years after the surgery
measure: Quality of the mesorectum specimen
timeFrame: 30 days after the surgery
measure: CRM status
timeFrame: 30 days after the surgery
measure: DRM status
timeFrame: 30 days after the surgery
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Liang Kang
role: PRINCIPAL_INVESTIGATOR
References: