NCT06999824

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jun 2025May 2027

First Submitted

Initial submission to the registry

May 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

9 months

First QC Date

May 22, 2025

Last Update Submit

May 22, 2025

Conditions

Cervical Cancers

Keywords

cervical cancerradical hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Bladder dysfunction

    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

    90 day after surgery

Study Arms (1)

nerve sparing radical hysterectomy

Patients undergoing nerve sparing radical hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women with cervical cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Lombardy, 20148, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Grazia Casadei

    Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    STUDY CHAIR

  • Valentina Chiappa

    Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Bogani, Prof

CONTACT

3803933116giorgiobogani@yahoo.it

Grazia casadei

CONTACT

3803933116giorgiobogani@yahoo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 31, 2025

Study Start

June 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations

IT(1)