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

Not Applicable

Recruiting

• Conditions: Advanced Cancer; Rectal Cancer
• Interventions: Procedure: Complete Preservation of Denonvilliers' Fascia

• Registration Number: NCT04672603
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-11
• Study First Posted: 2020-12-17
• Status Verified: 2021-04
• Study Start: 2021-04-08
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29
• Primary Completion: 2023-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 214

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete Preservation of Denonvilliers Fascia	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.

Primary Outcome Measures

Name	Time	Method
Incidence of urinary dysfunction	1 month	IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function
Incidence of sexual dysfunction	1 month	IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China