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TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME).
Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-PANP-TME | Experimental | Laparoscopy-assisted pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients |
|
| O-PANP-TME | Active Comparator | Open pelvic autonomic nerve preservation total mesorectum excision for male mid-low rectal cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-PANP-TME | Procedure |
| ||
| O-PANP-TME |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease free survival rate | 36 months | |
| Urinary function | Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function | 30 days |
| Sexual function | IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function | 30 days |
| 5-year disease free survival rate | 60 months | |
| Urinary function | Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function | 36 months |
| Sexual function | IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | 30 days | |
| 3-year overall survival rate | 36 months | |
| 3-year recurrence pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongbo Wei, M.D. Ph.D. | Contact | +86-189-2210-2969 | drweihb@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | 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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|
| 36 months |
| Mortality | 30 days |
| Morbidity | 36 months |
| Mortality | 36 months |
| 5-year overall survival rate | 60 months |
| 5-year recurrence pattern | 60 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |