Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Preservation of Denonvilliers Fascia during L-PANP surgery

• Study Type: Interventional
• Enrollment (Actual): 262
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male, 20 < age (years) < 71, informed consent;
2. Pathological diagnosis of rectal adenocarcinoma;
3. Tumors from anal edge 6 ~ 12 cm (measured by rigid proctoscope);
4. Preoperative staging T1-4 (T1-2 for anterior rectal wall) N0-2M0 rectal cancer (AJCC- 7th);
5. R0 TME surgical results is expected;
6. Preoperative ECOG physical status score 0/1;
7. Preoperative ASA grade I ~ III;
8. Normal urinary function (Bladder residual urine<100ml), normal erection function (IIEF-5>21) and ejaculation function grading as I level.

Exclusion Criteria:

1. Complicated with acute ileus, perforation or hemorrhage;
2. Tumors with extensive invasion of surrounding tissues, TME not applicable; Imaging examination in regional integration intumescent lymph nodes (maximum diameter 3 cm or higher);
3. With other malignant diseases or with other malignant disease within 5 years; With other diseases need surgery;
4. A history of abdominal and pelvic major operation;
5. People with severe mental illness, or cannot be evaluated due to cultural or psychological factors;
6. No sexual life;
7. Critical organ dysfunction, unbearable surgery;
8. Unstable angina, myocardial infarction, cerebral infarction or hemorrhage within 6 months;
9. Systemic corticosteroids or immunosuppressive medication history within 1 month;
10. Pre-existent true incontinence or severe stress urinary incontinence.

Exit criteria:

1. Confirmed as M1 during or after operation;
2. Conversion to abdominoperineal resection (APR)
3. Postoperatively confirmed as invading rectal intrinsic fascia, or T3 for anterior rectal wall;
4. Intraoperative confirmed regional lymph node fusion conglobation cannot ensure R0 resection;
5. Infiltrating major blood vessel and unresectable;
6. Intraoperative finding other diseases need simultaneous surgery;
7. Preoperative emergent severe complications, cannot carry out the study treatment;
8. Emergency surgery is needed;
9. Into this study, at any stage of the initiative exit or discontinue treatment; Prove to implement the healer violates this research plan.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preservation of Denonvilliers Fascia; Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients	Procedure: Preservation of Denonvilliers Fascia during L-PANP surgery; In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia
No Intervention: Excision of Denonvilliers Fascia; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival rate	3-year disease free survival rate	36 months
3-year recurrence pattern	3-year recurrence pattern	36 months
Morbidity	incidence of postoperatvie complications	30 days
Mortality	incidence of postoperatvie deaths	30 days
3-year overall survival rate	3-year overall survival rate	36 months
5-year overall survival rate	5-year overall survival rate	60 months
5-year disease free survival rate	5-year disease free survival rate	60 months
5-year recurrence pattern	5-year recurrence pattern	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

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Sixth Affiliated Hospital, Sun Yat-sen University; Nanfang Hospital, Southern Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 6, 2020
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: April 26, 2015
• First Submitted That Met QC Criteria: May 2, 2015
• First Posted (Estimated): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 17, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• 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: PED-PANP01