Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Neoadjuvant chemoradiotherapy has been recommended as the standard preoperative treatment for locally advanced rectal cancer. However, preoperative radiotherapy increases the risk of bowel dysfunction after sphincter-preserving surgery, for which patients suffer from incontinence, urgency, and unpredictability defecation problems. Furthermore, preoperative chemoradiotherapy is a potential risk factor of anastomotic leakage and stenosis after rectal cancer surgery. Unhealthy anastomosis, with both ends of injured bowel segments after pelvic radiation, is a major concern. When conventional surgical procedures would retain part of sigmoid colon that has been included in the radiation target, sphincter-preserving surgery with proximally extended resection margin could provide an intact proximal colon limb for the anastomosis. It is not known yet whether proximally extended resection improves postoperative bowel function or anastomotic integrity for patients with rectal cancer after neoadjuvant chemoradiotherapy. The proposed study will compare sphincter-preserving surgery with and without proximally extended resection margin, to observe the postoperative bowel function, as well as the incidence of anastomotic complication. This study will examine a new surgical strategy, which potentially benefits the patients undergoing neoadjuvant chemoradiotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age: 18-75 years old

• ECOG performance status: 0-2

• Histologically confirmed adenocarcinoma of the rectum

• Distal border of the tumor located ≤ 12 cm from the anal verge

• Primary stage T3-4 or any node-positive disease

• Undergoing long-course 5-fluorouracil based neoadjuvant chemoradiotherapy

• Conventional fractionated radiotherapy of at least 45 Gy

• Resectable disease after neoadjuvant chemoradiotherapy

• No evidence of distant metastasis

• Amenable to sphincter-preserving surgery

• Tolerable to general anesthesia

• Provision of written informed consent

Locations
Other Locations
China
Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Contact Information
Primary
Qiyuan Qin, M.D.
qinqy3@mail.sysu.edu.cn
86-20-38254052
Time Frame
Start Date: 2016-02
Estimated Completion Date: 2028-12
Participants
Target number of participants: 240
Treatments
Active_comparator: Conventional Resection
Patients receive conventional resection with standard proximal excision margin. The sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
Experimental: Proximally Extended Resection
Patients receive proximally extended resection. The whole sigmoid colon and rectum proximal to the tumor is removed, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
Related Therapeutic Areas
Sponsors
Leads: Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators: Peking Union Medical College Hospital, Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov