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
| Name | Class |
|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 multicenter 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservation of Denonvilliers Fascia | Experimental | Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients |
|
| Excision of Denonvilliers Fascia | No Intervention | Standard TME surgery (U-shaped excision of Denonvilliers fascia) in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservation of Denonvilliers Fascia during L-PANP surgery | Procedure | In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary function | Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function | 14 days |
| Sexual function | IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | incidence of postoperatvie complications | 30 days |
| 3-year overall survival rate | 3-year overall survival rate | 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Exit criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33234798 | Derived | Wei B, Zheng Z, Fang J, Xiao J, Han F, Huang M, Xu Q, Wang X, Hong C, Wang G, Ju Y, Su G, Deng H, Zhang J, Li J, Chen T, Huang Y, Huang J, Liu J, Yang X, Wei H; Chinese Postoperative Urogenital Function (PUF) Research Collaboration Group. Effect of Denonvilliers' Fascia Preservation Versus Resection During Laparoscopic Total Mesorectal Excision on Postoperative Urogenital Function of Male Rectal Cancer Patients: Initial Results of Chinese PUF-01 Randomized Clinical Trial. Ann Surg. 2021 Dec 1;274(6):e473-e480. doi: 10.1097/SLA.0000000000004591. |
Not provided
Not provided
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
| 3-year recurrence pattern | 3-year recurrence pattern | 36 months |
| Mortality | incidence of postoperatvie deaths | 30 days |
| 5-year overall survival rate | 5-year overall survival rate | 60 months |
| 5-year recurrence pattern | 5-year recurrence pattern | 60 months |
| 3-year disease free survival rate | 3-year disease free survival rate | 36 months |
| 5-year disease free survival rate | 5-year disease free survival rate | 60 months |
| Sexual function | International questionnaire of erectile function-5 (IIEF-5) | 12 months |
| Sexual function | Ejaculation function classification | 12 months |
| Urinary function | Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function | 12 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |