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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. PANP (pelvic autonomic nerve preservation) 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 (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).
In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservation of Denonvilliers Fascia | Experimental | Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients |
|
| Excision of Denonvilliers Fascia | Active Comparator | Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservation of Denonvilliers Fascia | Procedure | In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 3-year disease free survival rate | 36 months | |
| 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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| 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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| Excision of Denonvilliers Fascia | Procedure | In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia |
|
| 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 |