Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Proximally extended resectionProcedure: Conventional resection
- Registration Number
- NCT02649647
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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
- Prior or concurrent malignancies within the past 5 years except for effectively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
- Synchronous colon cancer
- History of colorectal resection except appendectomy
- Acute intestinal obstruction or perforation
- Multiple visceral resection
- Abdominoperineal resection
- American Society of Anesthesiologists (ASA) class Ⅳ or Ⅴ
- Pregnant or nursing, fertile patients do not use effective contraception
- Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Proximally Extended Resection 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. Conventional Resection 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.
- Primary Outcome Measures
Name Time Method Incidence of major bowel dysfunction at the time of 12 months after the restoration of defunctioning stoma 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.
- Secondary Outcome Measures
Name Time Method Incidence of anastomotic stenosis 12 months postoperatively 5-year overall survival 5 years Incidence of anastomotic leakage up to 6 months postoperatively Postoperative mortality up to 30 days postoperatively Postoperative morbidity up to 30 days postoperatively Quality of life impairment at the time of 60 months after the restoration of defunctioning stoma Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29.
Incidence of major bowel dysfunction at the time of 60 months after the restoration of defunctioning stoma Low anterior resection syndrome score (LARS score) will be used to assess the bowel function.
3-year disease free survival 3 years Incidence of anastomotic haemorrhage up to 1 month postoperatively Incidence of intraoperative complication at the time of surgery
Trial Locations
- Locations (1)
Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China