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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Advanced Cancer
• Intervention / Treatment: Procedure: Complete Preservation of Denonvilliers' Fascia

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bing Zeng, M.D.; Phone Number: 8613450366467; Email: zengbing3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Bing Zeng, M.D.; Phone Number: 8613450366467; Email: zengbing3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 71 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Complete Preservation of Denonvilliers' Fascia; Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year overall survival rate	1-year overall survival rate	1 year
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	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
Positive Circumferential Resection Margin Rate	Positive Circumferential Resection Margin Rate	1 week

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2021
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2025

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Urogenital Function; Denonvilliers' Fascia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: UGFS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No