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PROBHE: Prehabilitation with Botulinum Toxin A in complex hernia: an Italian prospective study on predictive scores of myofascial release.
EU CTIS ID: 2025-522451-25-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Participant is willing and able to give informed consent for participation in the trial
- • Defect width ≥ 10 cm
- • Loss of domain (LoD) ≥ 20% and cosmetic discomfort related to the ventral hernia, are negatively or positively influenced by BTA injections;
- • Compliance to follow-up
- • Male and female
- • Written informed consent to preoperative BTA injection and/or surgery
You likely can't join if
- • Medical or psychiatric conditions that compromises the patient’s ability to give informed consent or comply with the study protocol
- • Refuse to give informed consent to preoperative BTA injection and/or surgery
- • Personal reasons
- • Age < 18 years old
- • RDR ≥ 2
- • Defect width < 10 cm
See the full eligibility criteria
- • Participant is willing and able to give informed consent for participation in the trial
- • Defect width ≥ 10 cm
- • Loss of domain (LoD) ≥ 20% and cosmetic discomfort related to the ventral hernia, are negatively or positively influenced by BTA injections;
- • Compliance to follow-up
- • Male and female
- • Written informed consent to preoperative BTA injection and/or surgery
- • Age ≥ 18 years old
- • Primary ventral hernia
- • Incisional ventral hernia
- • RDR < 2
- • Medical or psychiatric conditions that compromises the patient’s ability to give informed consent or comply with the study protocol
- • Refuse to give informed consent to preoperative BTA injection and/or surgery
- • Personal reasons
- • Age < 18 years old
- • RDR ≥ 2
- • Defect width < 10 cm
- • LoD < 20%
- • Pregnancy and breastfeeding
- • Allergy/Intolerance to BTA
- • Neuromuscular disorders and diseases
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.