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This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| robot-assisted ISR | Active Comparator | Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic |
|
| laparoscopic ISR | Active Comparator | Patients with low rectal cancer undergo laparosocopic intersphincteric resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted surgery | Device | robot-assisted intersphincteric resection for low location rectal cancer(T=1&2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary function | The days of indwelling catheter after operation The overall efficiency of urination function | 6 months |
| Change in International Index of Erectile Function [IIEF] score | Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED) | 18 months |
| Change in FIQL scores | Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered | 18 months |
| Change in Female Sexual Function Index [FSFI] | Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tang Bo, M.D | Contact | +86 13883902288 | yupeiwu1961@aliyun.com | |
| Li Chuan, M.D | Contact | +86-18323479228 | lee_tran@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital | Recruiting | Chongqing | China |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| Laparoscopic surgery | Device | laparoscopic intersphincteric resection for low location rectal cancer(T=1&2) |
|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |