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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522451-25-00
Acronym
PRoBHe
Enrollment
1
Registered
2025-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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., 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, 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

Detailed description

• 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, • 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, When a PCS with TAR is performed, different percentage of ABR e PBR may correlate with efficacy outcomes of BTA injection:

Interventions

Sponsors

Azienda Socio Sanitaria Territoriale Ovest Milanese
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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., 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, 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

MeasureTime frame
• 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, • 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, When a PCS with TAR is performed, different percentage of ABR e PBR may correlate with efficacy outcomes of BTA injection:

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026