Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision

Rectal Cancer Clinical Trial

Official title:

A Prospective, Multicenter Clinical Study of Preservative Effect on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision for Male Rectal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049317
• Other study ID #: zhengyongbin01
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: September 24, 2028

Study information

• Verified date: September 2021
• Source: Renmin Hospital of Wuhan University
• Contact: Yongbin Zheng, M.D,Ph.D
• Phone: 13871189698
• Email: yongbinzheng[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Urinary and sexual dysfunctions are among the most common complications in rectal cancer surgery. The aim of this study was to investigate the protective effect of laparoscopic functional total mesorectum excision (FTME) on urinary and sexual function in male patients with mid-low rectal cancer. This is a prospective, single-arm, multicenter, uncontrolled, clinical study in 88 eligible subjects with mid-low rectal cancer. After informed consent, eligible patients will be performed laparoscopic FTME surgery. Patients' demographic, operative detail, postoperative outcomes and follow-up will be recorded prospectively.

Description:

Previously, our studies have demonstrated the presence of nerve plane in laparoscopic rectal cancer surgery, which was the overlying tiny membranous tissue including the nerves, the adipose tissue, and the extremely tiny capillaries around the nerve. As a consequence, the concept of nerve plane-oriented functional total mesorectal excision (FTME) was proposed as an optimal surgical procedure about pelvic autonomic nerve preservation in rectal cancer surgery. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum. This surgical procedure not only ensures radical resection but also protects PAN better, and the investigators also showed the difference between routine TME and FTME in our previous study, which included inferior mesenteric plexus preservation, station 253 nodes dissection, existence of the first gap, Waldeyer's fascia and Denonvillier's fascia (DVF) preservation, neurovascular bundles preservation, and completeness of mesorectum and nerve plane. Currently, it was a lack of higher-level evidence-based evidence to confirm the protective effect of laparoscopic FTME on urinary and sexual function in male patients with mid-low rectal cancer. In the present study, the investigators performed the prospective, single-arm, multicenter, uncontrolled clinical study, eligible patients will be performed laparoscopic FTME surgery. Postoperative sexual function, urinary function, complications, quality of life, recurrence rate, recurrence patterns, disease-free survival, and overall survival will be recorded prospectively. The results of the patients will be assessed to validate postoperative functional outcomes and oncologic outcomes of laparoscopic FTME surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: September 24, 2028
• Est. primary completion date: September 24, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male, 18-70 years of age, informed consent;

2. Tumors from anal edge 6 ~ 12 cm (measured by rigid proctoscope);

3. Rectal cancer confirmed pathologically by endoscopic biopsy;

4. Preoperative cT1-3aN0M0 stage (ESMO, 2013);

5. Ro resection is expected;

6. Normal urinary function, normal erection function and ejaculation function grading as I level;

Exclusion Criteria:

1. History of abdominal and pelvic major surgery;

2. Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer;

3. Pelvic or distant metastasis;

4. Neoadjuvant radiotherapy or chemoradiotherapy;

5. No sexual life;

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Laparoscopic FTME surgery
Nerve plane was defined as the overlying tiny membranous tissue including the nerves, the adipose tissue and the extremely tiny capillaries around the nerve. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum.

Locations

Country	Name	City	State
China	Yongbin Zheng	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (2)

Li K, He X, Tong S, Zheng Y. Nerve plane: An optimal surgical plane for laparoscopic rectal cancer surgery? Med Hypotheses. 2021 Sep;154:110657. doi: 10.1016/j.mehy.2021.110657. Epub 2021 Aug 5. — View Citation

Li K, He X, Zheng Y. An Optimal Surgical Plane for Laparoscopic Functional Total Mesorectal Excision in Rectal Cancer. J Gastrointest Surg. 2021 Oct;25(10):2726-2727. doi: 10.1007/s11605-021-05035-9. Epub 2021 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of sexual dysfunction	The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score =11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III.	6 months
Primary	Incidence of urinary dysfunction	The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score >8 points.	3 months
Secondary	Morbidity	incidence of postoperatvie complications	30 days
Secondary	Mortality	incidence of postoperatvie deaths	30 days
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	5-year overall survival rate	5-year overall survival rate	60 months
Secondary	5-year disease free survival rate	5-year disease free survival rate	60 months
Secondary	Incidence of sexual dysfunction	The 5-item version of the International Index of Erectile Function (IIEF-5) and ejaculation function are used to assess sexual function. the IIEF-5 total score ranged from 1 to 25, with a lower score indicating more severe erectile dysfunction, male sexual dysfunction was defined as the IIEF-5 score =11points. Ejaculation function was classified as: Grade I, normal ejaculation; Grade II: retrograde ejaculation; Grade III: anejaculation, and ejaculation dysfunction was identified as ejaculation function of grade II/III.	12 months
Secondary	Incidence of urinary dysfunction	The International Prostate Symptom Score (IPSS) are used to assess urinary function. the IIEF-5 total score ranged from 0 to 35, with a higher score indicating more severe erectile dysfunction,moderate-to-severe urinary dysfunction was defined as the IPSS score >8 points.	6 months