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Clinical Trials in Italy / NCT06999824
Starting soon Observational

Revisiting the Concept of Nerve Sparing Radical Hysterectomy

NCT06999824 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Phase
Observational
Started
2025-06-01
Last updated
2025-05-31

Condition(s) studied

Cervical Cancers

Study summary

Nerve-sparing radical hysterectomy aims to preserve the autonomic innervation of pelvic organs. In most studies, the preservation of the parasympathetic component of pelvic innervation is achieved by sparing the lymphovascular-neural tissue located at the base of the lateral paracervical tissue. This study explores an alternative surgical technique based on a different anatomical pathway of parasympathetic fibers, running more cranially and deeply within the pararectal space.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: (i) age ≥18 years; (ii) histologically confirmed cervical cancer; (iii) indication for type C1 (nerve-sparing) radical hysterectomy according to ESGO guidelines; and (iv) a minimum of 90 days of postoperative follow-up. Exclusion Criteria: (i) withdrawal of consent; (ii) prior abdominal and/or pelvic surgery; (iii) pre-existing urinary incontinence, detrusor overactivity, or detrusor underactivity; and (iv) pre-existing anorectal dysfunction Staging and architectural grade were defined according to the 2018 International Federation of Gynecology and Obstetrics (FIGO) recommendations, and histological subtypes were classified based on the World Health Organization (WHO) criteria

Primary outcome measure(s)

  • Bladder dysfunction — 90 day after surgery
    Bladder dysfunction following radical hysterectomy is typically defined as any postoperative impairment in bladder storage or emptying function, which may include: Delayed or incomplete bladder emptying Increased post-void residual volume (PVR). Detrusor underactivity or acontractility Urinary retention requiring catheterization Loss of sensation of bladder fullness Urinary urgency, frequency, or incontinence

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano Milan Lombardy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06999824 on ClinicalTrials.gov ↗ ← All trials in Italy