PROBHE: Prehabilitation with Botulinum Toxin A in complex hernia: an Italian prospective study on predictive scores of myofascial release.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Defect width < 10 cm
- •LoD < 20%
- •Pregnancy and breastfeeding
- •Allergy/Intolerance to BTA
- •Neuromuscular disorders and diseases
结局指标
主要结局
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
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
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.
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
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
次要结局
- • 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:
研究者
Camillo Leonardo Bertoglio
Scientific
Azienda Socio Sanitaria Territoriale Ovest Milanese