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Completed

NCT Number: NCT05933785

the Value of Transanal Endoscopic ISR

The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.

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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

Primary location

Ruijin Hospital, Shanghai, 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
  • preoperative stage as (y) cT1-3N0-2M0
  • lower margin of the tumor less than 5cm from the anus
  • tumor diameter ≤5cm

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

transanal endoscopic ISR

Procedure

perform ISR using laparoscopy through transanal port

Primary outcomes

  1. anal preservation rate

    Time frame: 1 year after sugery

    No conversion to APR and closure was closed within 1 year after surgery

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

Sponsors and collaborators

Lead sponsor

Shanghai Minimally Invasive Surgery Center

Other

Registry information

Official study title

The Value of Transanal Endoscopic Intersphincteric Resection (taE-ISR) in Extreme Anal Preservation in Ultra-low Rectal Cancer

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Mar 7, 2024

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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