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
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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