Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).

NCT02488707 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-07-02

No results posted yet for this study

Summary

A prospective study is planned for management of low rectal cancer with the aim of sphincter preservation and improving the oncological outcome of the patients, through comparing of both approaches minimally invasive techniques including transanal total mesorectal excision and laparoscopic intersphincteric resection.

Conditions

Interventions

PROCEDURE

laparoscopic intersphincteric resection (LISR group)

the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum

PROCEDURE

Transanal minimally invasive Total mesorectal excision (TAMIS group)

Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Osama eldamshety, PhD · Assistant Lecturer of surgical oncology

  • Sherif Kotb, PhD, MD · Professor of surgical oncology

  • Adel Fathi, PhD, MD · Lecturer of surgical oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-02-29
Completion
2016-04-30

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02488707 on ClinicalTrials.gov