Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer

NCT ID: NCT04672603

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-08
• Study Completion Date: 2025-05-01

Brief Summary

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.

Conditions

Rectal Cancer; Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Complete Preservation of Denonvilliers Fascia

Complete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.

Group Type: EXPERIMENTAL

Complete Preservation of Denonvilliers' Fascia

Intervention Type: PROCEDURE

Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia

Partial Preservation of Denonvilliers Fascia

Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Complete Preservation of Denonvilliers' Fascia

Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Pathological diagnosis of rectal adenocarcinoma;

2. Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);

3. Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;

4. R0 surgical results is expected by transabdominal or transanal TME/TSME;

5. 18 < age (years) < 71, informed consent;

6. Normal erection function (IIEF-5>21), ejaculation function grading as I level, FSFI > 26, normal urinary function (Bladder residual urine<100ml);

7. Preoperative ASA grade I ~ III, no serious systemic disease;

Exclusion Criteria

1. Preoperatively confirmed peritoneum or distant metastasis;

2. Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;

3. With other malignant diseases;

4. With acute ileus, perforation or hemorrhage,need emergency surgery;

5. Critical organs dysfunction, unable to tolerate laparoscopic surgery;

6. With severe mental illness, cannot be evaluated;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bing Zeng, M.D.

Role: CONTACT

zengbing3@mail.sysu.edu.cn

8613450366467

Facility Contacts

Bing Zeng, M.D.

Role: primary

zengbing3@mail.sysu.edu.cn

8613450366467

Other Identifiers

UGFS-01

Identifier Type: -

Identifier Source: org_study_id