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the Value of Transanal Endoscopic ISR

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05933785
Enrollment
260
Registered
2023-07-06
Start date
2018-01-02
Completion date
2023-05-30
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Brief summary

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.

Interventions

PROCEDUREtransanal endoscopic ISR

perform ISR using laparoscopy through transanal port

Sponsors

Shanghai Minimally Invasive Surgery Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
anal preservation rate1 year after sugeryNo conversion to APR and closure was closed within 1 year after surgery

Secondary

MeasureTime frameDescription
incidence of Defecation disorders6 months after surgeryA Wexner score \>10 indicated the existence of defecation dysfunction
incidence of positive distal resection margin30 days after surgeryA positive distal resection margin (DRM) was diagnosed with the presence of tumor cells within 1mm from the DRM

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026