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

NCT05049317 | Recruiting

• 1 other identifier: zhengyongbin01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Morbidity

  30 days

• Mortality

  30 days

• 3-year overall survival rate

  36 months

• 3-year disease free survival rate

  36 months

• 5-year overall survival rate

  60 months

Study Arms (1)

FTME group

EXPERIMENTAL

Participants will undergo laparoscopic FTME surgery.

Procedure: Laparoscopic FTME surgery

Interventions

Laparoscopic FTME surgery 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.

FTME group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, 18-70 years of age, informed consent;
• Tumors from anal edge 6 \~ 12 cm (measured by rigid proctoscope);
• Rectal cancer confirmed pathologically by endoscopic biopsy;
• Preoperative cT1-3aN0M0 stage (ESMO, 2013);
• Ro resection is expected;
• Normal urinary function, normal erection function and ejaculation function grading as I level;

You may not qualify if:

• History of abdominal and pelvic major surgery;
• Emergency surgery is needed due to the complication (bleeding, obstruction, or perforation) caused by rectal cancer;
• Pelvic or distant metastasis;
• Neoadjuvant radiotherapy or chemoradiotherapy;
• No sexual life;

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Yongbin Zheng

Wuhan, Hubei, 436513, China

RECRUITING

Related 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.

  PMID: 34388537 BACKGROUND

• 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.

  PMID: 34109532 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Yongbin Zheng, M.D,Ph.D

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongbin Zheng, M.D,Ph.D

CONTACT

13871189698; yongbinzheng@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 20, 2021
• Study Start: November 24, 2021
• Primary Completion: September 24, 2022
• Study Completion (Estimated): September 24, 2028
• Last Updated: November 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)