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

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Preservation of Denonvilliers Fascia during L-PANP surgery

• Registration Number: NCT02435758
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-26
• Study First Submitted QC: 2015-05-02
• Study First Posted: 2015-05-06
• Primary Completion: 2020-05-06
• Study Completion: 2023-06-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 262

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preservation of Denonvilliers Fascia	Preservation of Denonvilliers Fascia during L-PANP surgery	Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients

Primary Outcome Measures

Name	Time	Method
Sexual function	14 days	IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Urinary function	14 days	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function

Secondary Outcome Measures

Name	Time	Method
5-year overall survival rate	60 months	5-year overall survival rate
3-year recurrence pattern	36 months	3-year recurrence pattern
Mortality	30 days	incidence of postoperatvie deaths
Morbidity	30 days	incidence of postoperatvie complications
Sexual function	12 months	Ejaculation function classification
Urinary function	12 months	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
5-year recurrence pattern	60 months	5-year recurrence pattern
3-year overall survival rate	36 months	3-year overall survival rate
3-year disease free survival rate	36 months	3-year disease free survival rate
5-year disease free survival rate	60 months	5-year disease free survival rate

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China