Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer.

Long Term Outcomes After Laparoscopic Intersphincteric Resection With Total Mesorectal Excision for Low Rectal Cancer: a Double Blind Randomized Clinical Trial

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02468362

Acronym

ISR-TME

Enrollment

112

Registered

2015-06-10

Start date

2014-04-30

Completion date

2019-10-31

Last updated

2015-06-10

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

Conditions

Low Rectal Cancer

Keywords

Intersphincteric resection, laparoscopic rectal rescetion, total mesorectal excsison

Brief summary

Through a double blinded study, patients with low rectal cancer will be randomized into two equal groups to compare between the 5 year disease free survival as a primary outcome measure.

Interventions

PROCEDURElaparoscopic intersphincteric resection

laparoscopic intersphincteric resection for low rectal cancer

PROCEDUREopen intersphincteric resection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Low rectal cancer below 5 cm from the anal verge * Fit for laparoscopic total mesorectal excsion * T2, T3 rectal cancer * No distant metstasis

Exclusion criteria

* T1, AND T4 * Distant metastasis * Tumor infiltrating the dentate line * unwilling to participate

Design outcomes

Primary

Measure	Time frame
Disease Free survival	5 years

Secondary

Measure	Time frame
Local recurrence	5 years
Distant metstasis	5 years
5 year survival	5 years

Outcome results

None listed

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