Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive surgery toal mesentery excision for rectal cancer.
Natural orifice transluminal endoscopic surgery (NOTES) give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transanal minimal invasive surgery(TAMIS) for rectal cancer show that such NOTES procedures are feasible and safe. And also, lots of experimental studies and small case series reporting the feasibility of transanal anterior resection with single incision laparoscopic surgery(SILS) port or other devices. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function, sexual function, QOF) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transanal minimal invasive total mesentery excision for rectal cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional laparoscopic | Active Comparator | conventional laparoscopic total mesentery excision surgery for rectal cancer. |
|
| Transanal hybrid-laparoscopic | Experimental | Transanal hybrid-laparoscopic total mesentery excision surgery for rectal cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional laparoscopic total mesentery excision | Procedure | conventional laparoscopic total mesentery excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of the total mesorectal excision(TME) based on standard guidelines on pathologic evaluation of TME specimens. | Lymph nodes number; rate of positive circumferential resection margin(CRM); | 1-6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of 30-day perioperative complications including intraoperative, and postoperative complications | bleeding, injury of adjacent organs, ileus, leakage, infection | 0-30 days |
| Incidence of long-term complications |
| Measure | Description | Time Frame |
|---|---|---|
| defecating functional outcomes | constipation score and incontinence score | 1-6 years |
| sexual functional outcomes | We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (International Index of Erectile Function (IIEF) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Weidong Tong, Prof | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping hospital | Chongqing | Chongqing Municipality | 400042 | China |
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| transanal hybrid-laparoscopic total mesentery excision | Procedure | transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA. |
|
|
incision hernia,
| 1-6 years |
| Oncologic outcomes in subjects receiving transanal hybrid-laparoscopic total mesentery excision. | overall survive rate and disease free survive rate of 3 and 5 years; recurrence rate | 1-6 years |
| 1-6 years |
| Quality of life outcomes evaluation | We examine before operation, 3 months after, 6 months after, 12 months after, 24 months after operation, by questionnaires (Short Form-36 (SF36) and Gastro-Intestinal Functional Outcome(GIFO)) . | 1-6 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |