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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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.
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.
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGIncidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. Number of participants with major LARS will be calculated for the incidence of major bowel dysfunction.
Time frame: at the time of 12 months after the restoration of defunctioning stoma
Incidence of anastomotic leakage
Time frame: up to 6 months postoperatively
Incidence of anastomotic stenosis
Time frame: 12 months postoperatively
Incidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
Time frame: at the time of 36 months after the restoration of defunctioning stoma
Incidence of major bowel dysfunction
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
Time frame: at the time of 60 months after the restoration of defunctioning stoma
3-year disease free survival
Time frame: 3 years
5-year overall survival
Time frame: 5 years
Incidence of anastomotic haemorrhage
Time frame: up to 1 month postoperatively
Incidence of intraoperative complication
Time frame: at the time of surgery
Postoperative morbidity
Time frame: up to 30 days postoperatively
Postoperative mortality
Time frame: up to 30 days postoperatively
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Time frame: at the time of 12 months after the restoration of defunctioning stoma
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Time frame: at the time of 36 months after the restoration of defunctioning stoma
Quality of life impairment
Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Time frame: at the time of 60 months after the restoration of defunctioning stoma
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