TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy.

NACompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
Rectal Cancer
Interventions
PROCEDURE

Open intersphincteric resection

"laparotomy arm: surgical Instruments for open approach operation: Abdominal anterior resection combined with peranal intersphincteric resection of the rectum~Abdominal step a high ligation of the inferior mesenteric artery is performed together with a full mobilization of the left colon. A circular incision of the anal canal is performed 1 cm below the tumour. Both the mucosa and the muscular layer are incised to transect the internal anal sphincter. A coloanal anastomosis, transverse coloplasty or colonic J-pouch and a diverting loop ileostomy are associated with the hand-sewn coloanal anastomosis.~laparoscopic approach group: instruments used: laparoscopic instruments mentioned at the arm description~intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach"

DEVICE

transanal minimally invasive intersphincteric resection

minimally invasive approach group: instruments used: laparoscopic instruments mentioned at the arm description instruments: laparoscopic instruments mentioned in the laparoscopic rectal resection arm intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach

Trial Locations (2)

Unknown

Mansoura oncology centre, Al Mansurah

Mansoura university oncology centre, Al Mansurah

All Listed Sponsors
collaborator

Mansoura University

OTHER

collaborator

Marche Polytechnic university, Ancona, Italy

UNKNOWN

lead

Osama Mohammad Ali ElDamshety

OTHER

NCT01836926 - TaTME Versus Open Intersphincteric Resection After Neoadjuvant Concurrent Chemoradiotherapy. | Biotech Hunter | Biotech Hunter