Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia: a Multicenter, Randomized, Parallel-group, Evaluator Blinded, Phase III Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 52
- 主要终点
- Number of Large Hiatal Hernia recurrence
研究概览
简要总结
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice.
In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date.
Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications.
The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.
详细描述
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. Aging of the population and improvement of perioperative management may suggest that the number of these interventions will increase in the next few years. However, recurrence is common and has been described in up to 30% of patients who have undergone laparoscopic repair after a median follow up of 24 months.
The use of mesh reinforcement has been suggested to help preventing recurrence after LHH repair with non-absorbable and absorbable mesh.
In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date.
Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications.
The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing laparoscopic primary repair for symptomatic LHH. LHH is defined as a hiatal hernia larger than 5 cm in axial length as diagnosed at barium series and/or CT-scan with contrast swallow and/or CT-scan with contrast injection with axial reconstruction.
- •Symptomatic hiatal hernia: heartburn and/or regurgitation and/or epigastric pain and/or dysphagia and/or anemia (if exclusion of other origin);
- •Patient aged ≥ 18 years;
- •Patient affiliated to a social security system or beneficiary of the same;
- •Free written informed consent signed by the participant and the investigator (no later than the inclusion day and before performing any examination required for the study).
排除标准
- •Patient undergoing reoperation for recurrent LHH repair;
- •Emergency presentation needing an operation in a delay <6 hours;
- •Asymptomatic hiatal hernia;
- •American anesthesiologist score >3;
- •Recurrent hiatal hernia and previous surgical interventions involving gastroesophageal junction;
- •Brachyesophagus defined as the impossibility to achieve an intraabdominal length of the esophagus of at least 3cm after reduction of hernia contents and complete dissection and resection of the hernia sac;
- •Previous major upper gastrointestinal surgery;
- •Inability to perform primary closure of the crura;
- •Pregnant or breast-feeding woman;
- •Persons deprived of liberty or under guardianship or incapable of giving consent;
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator.
结局指标
主要结局
Number of Large Hiatal Hernia recurrence
时间窗: Month 24
Radiologic recurrence will be identified at 24 months by an experienced radiologist blinded to the result of randomization and defined as the presence of any abdominal content located above the level of the diaphragm on CT-scan.
次要结局
- Evaluation of Quality of life (QoL) by EQ-VAS(Month 24)
- measuring fever with a thermometer.Temperature is measured in degree Celsius (°C), between 34,7 and 40 °C.(Month 24)
- measurement of weight(Month 24)
- measurement of blood pressure(Month 24)
- Evaluation of Quality of life (QoL) by GIQLI,(Month 24)
- Evaluation of Quality of life (QoL) by SF36 questionnaire(Month 24)
- Evaluation of Quality of life (QoL) by EQ-5D-5L(Month 24)
- measurement of fever(Month 12)