Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid Cancer

PHASE3RecruitingINTERVENTIONAL
Enrollment

366

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2025

Conditions
Colorectal Cancer
Interventions
PROCEDURE

transrectal specimen extraction

After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.

PROCEDURE

Conventional laparoscopic surgery

High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.

Trial Locations (1)

100021

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER