ClinicalTrials.gg
Not yet recruitingNCT06999824Neuro-NerveUpdated May 31, 2025

Revisiting the Concept of Nerve Sparing Radical Hysterectomy

An observational study in Cervical Cancers, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
Female
01

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.

Read the detailed description

The concept of preserving pelvic autonomic innervation during radical hysterectomy was first introduced by Yabuki, who emphasized the relevance of pelvic neuroanatomy in supporting nerve-sparing techniques. His work laid the foundation for later studies aiming to establish a reproducible surgical method for preserving both sympathetic and parasympathetic pathways. Anatomically, there is broad consensus regarding the course of the hypogastric (sympathetic) nerves and the strategies to preserve them during radical hysterectomy. However, there is no complete consensus regarding the preservation of parasympathetic fibers. Most current techniques derive from the approach described by Shingo Fujii in 2008, which involves the identification of the deep uterine veins within the lateral paracervical tissues to preserve the lymphovascular and parasympathetic fibers situated between the deep uterine vein and the pelvic wall.

However, in 2004, Raspagliesi et al. introduced a novel anatomical consideration, postulating the existence of two distinct groups of parasympathetic fibers-both originating from the sacral roots (S2-S4). The first group (named Group A) corresponds to the fibers preserved in the Fujii technique. The second group (named Group B) comprises three distinct fiber bundles running on a more cranial plane, within the pararectal space. The anatomical presence of these Group B fibers was initially reported by Baader and Herrmann in 2003; although without a precise description of their anatomical landmarks or functional significance. In the Raspagliesi et al. studises, both fiber groups were identified; however, Group A fibers were routinely resected to maintain the standard C2-type radical hysterectomy technique, which allowed for a shorter operative time. Conversely, Group B fibers were preserved without compromising bladder functional recovery. Current evidence suggests that postoperative bladder and rectal functional outcomes are comparable between the two approaches, indicating that preservation of Group A fibers may not be essential for maintaining pelvic autonomic function.

Most published studies based on the Fujii technique focus on preserving Group A fibers while overlooking the existence or relevance of Group B fibers, which often lie outside the standard surgical field and thus remain intact by default. This lack of anatomical and neurofunctional data on Group B has led some authors, including Muallem, to question their existence altogether.

Although intraoperative neurophysiological techniques have significantly evolved in recent decades, their application to pelvic autonomic nerve assessment remains limited due to the need for specialized protocols and a lack of standardized methodologies. Of note, no electrophysiology studies confirmed the value of preserving Group A fibers, thus highlighting the importance of further investigating the functional role of Group B fibers in maintaining pelvic autonomic function.

To address this gap, we designed a prospective study to test the hypothesis that the second group of parasympathetic fibers (Group B) does indeed exist and is functionally capable of autonomously innervating pelvic effector organs (bladder and rectum). Using intraoperative neurophysiological monitoring (IONM) and cystometry, we aim to assess the functional role of pelvic splanchnic nerves in autonomic control during nerve-sparing radical hysterectomy. Our findings may support the adoption of a safer and more effective nerve-sparing surgical technique by validating the role of these deeper parasympathetic fibers.

02

Conditions studied

  • Cervical Cancers

Keywords

  • cervical cancer
  • radical hysterectomy
03

In context

Uterine Cervical Neoplasms

1,927 studies on the registry are indexed under Uterine Cervical Neoplasms; 576 are open to participants now.

This study's planned enrollment of 15 is below the median of 220 across 429 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 172 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

women with cervical cancer

Eligibility criteria

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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • nerve sparing radical hysterectomy

    Patients undergoing nerve sparing radical hysterectomy

06

What researchers measure

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

    Time frame: 90 day after surgery

07

Study locations

1 site
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
    Milan, Lombardy 20148, Italy
08

References and documents

Individual participant data

Plan to share: Undecided — Will be share data only at the end of teh study

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06999824
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
May 31, 2025

Study contacts

Giorgio Bogani, Prof
Contact
giorgiobogani@yahoo.it
3803933116
Grazia casadei
Contact
giorgiobogani@yahoo.it
3803933116
Grazia Casadei
study chair · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Valentina Chiappa
principal investigator · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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