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| Name | Class |
|---|---|
| Shanghai Changzheng Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Resection | Active Comparator | 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. |
|
| Proximally Extended Resection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional resection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | at the time of 12 months after the restoration of defunctioning stoma |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anastomotic leakage | up to 6 months postoperatively | |
| Incidence of anastomotic stenosis | 12 months postoperatively | |
| Incidence of major bowel dysfunction |
| Measure | Description | Time Frame |
|---|---|---|
| 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 major bowel dysfunction in patients with tumor of different location | at the time of 36 months after the restoration of defunctioning stoma |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiyuan Qin, M.D. | Contact | 86-20-38254052 | qinqy3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Wang, MD, PhD | Sixth Affiliated Hospital, Sun Yat-sen University | Study Director |
| Hui Wang, M.D. | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Proximally extended resection | Procedure | 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. |
|
Low anterior resection syndrome score (LARS score) will be used to assess the bowel function. |
| 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. | at the time of 60 months after the restoration of defunctioning stoma |
| 3-year disease free survival | 3 years |
| 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 | Quality of life will be assessed by EORTC QLQ-C30 and EORTC QLQ-CR29. | 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. | 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. | at the time of 60 months after the restoration of defunctioning stoma |
| Incidence of major bowel dysfunction in patients with tumor of different location | at the time of 60 months after the restoration of defunctioning stoma |
| Incidence of anastomotic complication in patients with tumor of different location | up to 12 months postoperatively |
| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |