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Completed

NCT Number: NCT05108753

Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China

Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.

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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–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) score I to III
  • A biopsy proven histological diagnosis of rectal carcinoma
  • Undergoing transanal total mesorectal excision

Exclusion criteria

  • Pregnant or lactating women
  • Synchronous rectal carcinoma
  • History of colorectal cancer or other malignant tumors
  • Clinical evidence of metastasis
  • Emergency procedure

Treatment and study plan

Procedure/Surgery

Other

Transanal Total Mesorectal Excision

Primary outcomes

  1. incidence of anastomotic leakage

    Time frame: thirty days after surgery

    according to the International Rectal Cancer Study Group

Secondary outcomes

  1. incidence of Defecation disorders

    Time frame: 6 months after surgery

    A Wexner score >10 indicated the existence of defecation dysfunction

  2. incidence of positive distal resection margin

    Time frame: 30 days after surgery

    A positive distal resection margin (DRM) was diagnosed with the presence of tumor cells within 1mm from the DRM

  3. incidence of positivecircumferential resection margin

    Time frame: 30 days after surgery

    The positive circumferential resection margin (CRM) was defined as the presence of tumor cells within 1 mm from the CRM

Sponsors and collaborators

Lead sponsor

Shanghai Minimally Invasive Surgery Center

Other

Registry information

Official study title

Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China: Retrospective Study of the First Twenty-five Cases in Seven High-volume Centers

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

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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