PROBHE: Prehabilitation with Botulinum Toxin A in complex hernia: an Italian prospective study on predictive scores of myofascial release.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Socio Sanitaria Territoriale Ovest Milanese

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

Trial duration

17 Feb 2026 → ongoing

Decision date (initial)

2025-11-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

IPSEN S.p.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Investigation if there is a change in RDR, CSI, hernia width, length and width of LM and abdominal cavity volume and diameters after BTA injection in LM of abdominal wall.

Secondary objectives 1

1. Assessment of the correlation between the variation of preoperative indices and the surgical strategy applied.

Conditions and MedDRA coding

Large hernia width, chronically retracted lateral abdominal wall muscles, and irreducible visceral content in the hernia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. • Participant is willing and able to give informed consent for participation in the trial
2. • Loss of domain (LoD) ≥ 20% and cosmetic discomfort related to the ventral hernia, are negatively or positively influenced by BTA injections;
3. • Compliance to follow-up
4. • Male and female
5. • Written informed consent to preoperative BTA injection and/or surgery
6. • Age ≥ 18 years old
7. • Primary ventral hernia
8. • Incisional ventral hernia
9. • RDR < 2
10. • Defect width ≥ 10 cm

Exclusion criteria 10

1. • Medical or psychiatric conditions that compromises the patient’s ability to give informed consent or comply with the study protocol
2. • Personal reasons
3. • Age < 18 years old
4. • RDR ≥ 2
5. • Defect width < 10 cm
6. • LoD < 20%
7. • Pregnancy and breastfeeding
8. • Allergy/Intolerance to BTA
9. • Neuromuscular disorders and diseases
10. • Refuse to give informed consent to preoperative BTA injection and/or surgery

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. RDR is the ratio between the sum of the width of two recti to defect width. According to Love et al., with each increase of 0.5 in the RDR value, a linear decrease in the need for AMR of approximately 20% is achieved.
2. CSI is calculated choosing a fixed point on a preoperative axial computed tomographic (CT) scan (aorta) and the medial leading edges of the rectus abdominus muscles. A CSI > 0.146 is a predictive score of myofascial release
3. Hernia width, LM length and width, and abdominal volume and diameters will also be measured. A hernia width > 10 cm is a predictive score of myofascial release

Secondary endpoints 3

1. • PBR is defined as % of peritoneal sac needed to achieve complete posterior fascial closure. It is the ratio between the area of peritoneal sac and the area of the posterior plane, obtained during the preperitoneal/pre-transversalis dissection
2. • ABR is defined as % of peritoneal sac needed to achieve complete anterior fascial closure. It is the ratio between the area of the peritoneal sac and the area of the anterior plane, obtained during the subcutaneous dissection
3. When a PCS with TAR is performed, different percentage of ABR e PBR may correlate with efficacy outcomes of BTA injection:

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Socio Sanitaria Territoriale Ovest Milanese

Sponsor organisation

Azienda Socio Sanitaria Territoriale Ovest Milanese

Address

Via Papa Giovanni Paolo II

City

Legnano

Postcode

20025

Country

Italy

Scientific contact point

Organisation

Azienda Socio Sanitaria Territoriale Ovest Milanese

Contact name

Camillo Leonardo Bertoglio

Public contact point

Organisation

Azienda Socio Sanitaria Territoriale Ovest Milanese

Contact name

Camillo Leonardo Bertoglio

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications