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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Incidence of sexual dysfunction [Срок оценки: 6 months]
• Incidence of urinary dysfunction [Срок оценки: 3 months]

Вторичные конечные точки (8)

• Morbidity [Срок оценки: 30 days]
• Mortality [Срок оценки: 30 days]
• 3-year overall survival rate [Срок оценки: 36 months]
• 3-year disease free survival rate [Срок оценки: 36 months]
• 5-year overall survival rate [Срок оценки: 60 months]
• 5-year disease free survival rate [Срок оценки: 60 months]
• Incidence of sexual dysfunction [Срок оценки: 12 months]
• Incidence of urinary dysfunction [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Yongbin Zheng — Ухань

Публикации

• 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
• 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

Идентификаторы

NCT: NCT05049317 · zhengyongbin01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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