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Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete Preservation of Denonvilliers Fascia | Experimental | Complete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients. |
|
| Partial Preservation of Denonvilliers Fascia | No Intervention | Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complete Preservation of Denonvilliers' Fascia | Procedure | Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sexual dysfunction | IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function | 1 month |
| Incidence of urinary dysfunction | IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sexual dysfunction | IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function | 9 months |
| Incidence of urinary dysfunction | IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bing Zeng, M.D. | Contact | 8613450366467 | zengbing3@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| 9 months |
| Quality of life assessed with GIQLI questionnaires | GIQLI questionnaires are used to assess quality of life | 1month |
| Quality of life assessed with GIQLI questionnaires | GIQLI questionnaires are used to assess quality of life | 9 months |
| 1-year local recurrence | 1-year local recurrence | 1 year |
| 1-year overall survival rate | 1-year overall survival rate | 1 year |
| Positive Circumferential Resection Margin Rate | Positive Circumferential Resection Margin Rate | 1 week |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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