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CompletedNCT05682794Updated Jan 12, 2023

Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

An observational study in Rectal Cancer, sponsored by Sun Yat-sen University. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-12.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,502
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Rectal Cancer

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Keywords

  • Rectal cancer
  • taTME
  • Local recurrence
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In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's enrollment of 2,502 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Low-mid rectal cancer within Stage III.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,502 participants (actual)
Patient registry
No

Groups and cohorts

  • taTME

    patients who underwent transanal total mesorectal excision

    Procedure: transanal total mesorectal excision

  • laTME

    patients who underwent laparoscopic total mesorectal excision

Interventions

  • Proceduretransanal total mesorectal excision

    transanal TME

    Also known as: laparoscopic total mesorectal excision

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What researchers measure

Primary outcomes

  1. Overall survival rate

    Time frame: 5 years after the surgery

  2. disease-free survival ratev

    Time frame: 5 years after the surgery

Secondary outcomes

  1. 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

    Time frame: 3 years after the surgery

  2. 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.

    Time frame: 5 years after the surgery

  3. Quality of the mesorectum specimen

    The quality of the resected mesorectum was classified into three grades: (a) incomplete, (b) nearly complete, and (c) complete

    Time frame: 30 days after the surgery

  4. CRM status

    The CRM was regarded as positive if the tumor distance or malignant lymph node to CRM was ≦1 mm.

    Time frame: 30 days after the surgery

  5. DRM status

    The DRM was regarded as positive if it was microscopically involved by or ≦1 mm from the tumor margins.

    Time frame: 30 days after the surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided — The data can be obtained with a proper request.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05682794
Lead sponsor
Sun Yat-sen University
Responsible party
Yanhong Deng (Professor, Sun Yat-sen University) — Principal investigator
First posted
Jan 12, 2023
Start date
Jan 2014
Primary completion
Oct 2022
Completion
Oct 2022
Last update
Jan 12, 2023

Study contacts

Liang Kang
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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