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

NCT ID: NCT02435758

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2023-06-15

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.

Conditions

Rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Preservation of Denonvilliers Fascia during L-PANP surgery

Intervention Type: PROCEDURE

In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Preservation of Denonvilliers Fascia during L-PANP surgery

In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Hongbo Wei

Assistant to the Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33234798 (View on PubMed)

Other Identifiers

PED-PANP01

Identifier Type: -

Identifier Source: org_study_id