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

Rectal Cancer Clinical Trial

Official title:

Effects of Complete Preservation Versus Partial Preservation of Denonvilliers' Fascia on Postoperative Urogenital Function in Locally Advanced Non-anterior Mid-low Rectal Cancer Patients：A Multicenter，Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672603
• Other study ID #: UGFS-01
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2021
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Bing Zeng, M.D.
• Phone: 8613450366467
• Email: zengbing3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Cancer
• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Complete Preservation of Denonvilliers' Fascia
Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Incidence of sexual dysfunction	IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function	9 months
Secondary	Incidence of urinary dysfunction	IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function	9 months
Secondary	Quality of life assessed with GIQLI questionnaires	GIQLI questionnaires are used to assess quality of life	1month
Secondary	Quality of life assessed with GIQLI questionnaires	GIQLI questionnaires are used to assess quality of life	9 months
Secondary	1-year local recurrence	1-year local recurrence	1 year
Secondary	1-year overall survival rate	1-year overall survival rate	1 year
Secondary	Positive Circumferential Resection Margin Rate	Positive Circumferential Resection Margin Rate	1 week