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RECRUITING
NCT02649647
NA

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2016-02

Completion Date

2028-12

Last Updated

2023-12-06

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Conventional resection

The conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

PROCEDURE

Proximally extended resection

The modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China