Randomized Trial of Sphincter-Preserving Surgery With Proximally Extended Resection Margin on Bowel Function and Anastomotic Complication for Rectal Cancer Patients After Neoadjuvant Chemoradiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Incidence of major bowel dysfunction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Incidence of major bowel dysfunction
Time Frame: 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 Outcomes
- Incidence of anastomotic leakage(up to 6 months postoperatively)
- 5-year overall survival(5 years)
- 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)
- Incidence of major bowel dysfunction(at the time of 60 months after the restoration of defunctioning stoma)
- 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)
- Incidence of anastomotic stenosis(12 months postoperatively)