Clinical trial NCT05049317: Multicenter Study on Postoperative Urinary and Sexual Function During Laparoscopic Functional Total Mesorectum Excision
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Nerve plane
Sexual dysfunction
Urinary dysfunction
Total mesorectal excision
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 88
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Incidence of sexual dysfunction
timeFrame: 6 months
measure: Incidence of urinary dysfunction
timeFrame: 3 months
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 5-year overall survival rate
timeFrame: 60 months
measure: 5-year disease free survival rate
timeFrame: 60 months
measure: Incidence of sexual dysfunction
timeFrame: 12 months
measure: Incidence of urinary dysfunction
timeFrame: 6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Yongbin Zheng
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Yongbin Zheng, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.