Rectal Cancer
Conditions
Keywords
Rectal cancer, Neoadjuvant therapy, Chemoradiotherapy, Resection margin, Bowel function, Anastomosis
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.
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.
Sponsors
Shanghai Changzheng Hospital
Peking Union Medical College Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major bowel dysfunction | at the time of 36 months after the restoration of defunctioning stoma | Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. |
| 5-year overall survival | 5 years | — |
| Incidence of anastomotic haemorrhage | up to 1 month postoperatively | — |
| Incidence of intraoperative complication | at the time of surgery | — |
| Postoperative morbidity | up to 30 days postoperatively | — |
| Postoperative mortality | up to 30 days postoperatively | — |
| Quality of life impairment | at the time of 12 months after the restoration of defunctioning stoma | Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29. |
| Incidence of anastomotic leakage | up to 6 months postoperatively | — |
| Incidence of anastomotic stenosis | 12 months postoperatively | — |
| 3-year disease free survival | 3 years | — |
Other
| Measure | Time frame |
|---|---|
| Operative duration by minutes | at the time of surgery |
| Intraoperative blood loss by millilitres | at the time of surgery |
| Postoperative rehabilitation time | up to 1 months postoperatively |
| Postoperative hospital stay by days | up to 1 months postoperatively |
| Incidence of major bowel dysfunction in patients with tumor of different location | at the time of 12 months after the restoration of defunctioning stoma |
| Incidence of anastomotic complication in patients with tumor of different location | up to 12 months postoperatively |
Countries
China
Contacts
Primary ContactQiyuan Qin, M.D.
Outcome results
None listed