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Completed

NCT Number: NCT05682794

Transanal Versus Laparoscopic Total Mesorectal Excision: a Cohort

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years old
  • Confirmed rectal adenocarcinoma cancer pathologically
  • Tumor location ≦ 12 cm from the anal margin
  • Willing and able to provide written informed consent for participation in this study

Exclusion criteria

  • Distant metastasis before surgery
  • More than one colorectal tumor at diagnosis
  • Familial adenomatous polyposis
  • Recurrent rectal cancer
  • Undergo transanal minimally invasive surgery
  • Undergo palliative treatment
  • Undergo emergency surgery

Treatment and study plan

transanal total mesorectal excision

Procedure

transanal TME

Other names: laparoscopic total mesorectal excision

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

    Time frame: 3 years after the surgery

    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

  2. Cancer special survival rate

    Time frame: 5 years after the surgery

    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.

  3. Quality of the mesorectum specimen

    Time frame: 30 days after the surgery

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

  4. CRM status

    Time frame: 30 days after the surgery

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

  5. DRM status

    Time frame: 30 days after the surgery

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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Transanal Versus Laparoscopic Total Mesorectal Excision: a Prospective Observational Cohort

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2023
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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