Proximally Extended Resection for Rectal Cancer After Neoadjuvant Chemoradiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional resection, Proximally extended resection.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Primary outcome measures
- Incidence of major bowel dysfunction [Time frame: at the time of 12 months after the restoration of defunctioning stoma]
Secondary outcome measures (12)
- 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 [Time frame: at the time of 36 months after the restoration of defunctioning stoma]
- Incidence of major bowel dysfunction [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 [Time frame: at the time of 12 months after the restoration of defunctioning stoma]
- Quality of life impairment [Time frame: at the time of 36 months after the restoration of defunctioning stoma]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT02649647 · PERN2015019