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

NCT ID: NCT05049317

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2028-09-24

Brief 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.

Detailed 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.

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Nerve plane; Sexual dysfunction; Urinary dysfunction; Total mesorectal excision

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FTME group

Participants will undergo laparoscopic FTME surgery.

Group Type: EXPERIMENTAL

Laparoscopic FTME surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongbin Zheng, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

Yongbin Zheng

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongbin Zheng, M.D,Ph.D

Role: CONTACT

Phone: 13871189698

Email: yongbinzheng@whu.edu.cn

Facility Contacts

Yongbin Zheng, M.D,Ph.D

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 34388537 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34109532 (View on PubMed)

Other Identifiers

zhengyongbin01

Identifier Type: -

Identifier Source: org_study_id