RecruitingNot ApplicableNCT02649647

Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

240 participants

Start Date

Feb 1, 2016

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether extending a surgical procedure further up the colon (a more extensive resection) in patients with rectal cancer who have received pre-surgery chemotherapy and radiation leads to better outcomes, particularly for patients whose cancer sits close to the junction of the colon and rectum. **You may be eligible if...** - You have been diagnosed with rectal cancer - You have completed pre-surgery (neoadjuvant) chemotherapy and radiation therapy - Your tumor is located in the upper part of the rectum near where it meets the colon - You are scheduled for surgical removal of the tumor - You are healthy enough to undergo surgery **You may NOT be eligible if...** - Your cancer has spread to distant organs (stage 4 / metastatic disease) - You have had previous surgery in the same area of the bowel - You have serious conditions that make major surgery unsafe - Your tumor is located in the lower rectum far from the colon junction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREConventional 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.

PROCEDUREProximally 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

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NCT02649647


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