Randomized control trial comparing laparoscopic ventral hernia repair using IPOM (intraperitoneal onlay mesh), IPOM-Plus and IPOM with peritoneal bridging techniques.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- â— To compare the incidence of development of seroma formation among the three
研究概览
简要总结
Common laparoscopic approaches for ventral hernia repair are simple intraperitoneal Onlay mesh (IPOM), and IPOM with defect closure before placement of mesh (IPOM-plus), Another approach IPOM with peritoneal bridging technique is also reported to be equally good. Surgical outcome among the three methods of LVHR (IPOM, IPOM-PLUS and IPOM with peritoneal bridging) is reported in the literature with a lot of subjective variation. There is also a paucity in the literature which compares these three techniques of LVHR. Our study aims at comparing the LVHR using IPOM, IPOM-PLUS, and IPOM with peritoneal bridging techniques in terms of surgical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All consenting patients of age >18/ <70 years presenting to department of surgery for a given duration with evidence of ventral wall hernia.
- •2.Abdominal wall hernia with defect size of length <10cm and width <8cm.
- •only will be included.
排除标准
- •1.Patients unfit for laparoscopy under general anesthesia.
- •2.Irreducible, strangulated or hernia with unhealthy skin over the sac.
- •3.Patient with BMI>35 kg/m2
- •Patient with positive viral markers i.e. HIV, HBsAg, anti-HCV 5.Recurrent Hernia.
结局指标
主要结局
â— To compare the incidence of development of seroma formation among the three
时间窗: â— To compare the incidence of development of seroma formation among the three | procedures at 48 hours & 5th day clinically & USG at 10th day after surgery. | â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days | after surgery. | â— To compare the short-term recurrence (6 months).
procedures at 48 hours & 5th day clinically & USG at 10th day after surgery.
时间窗: â— To compare the incidence of development of seroma formation among the three | procedures at 48 hours & 5th day clinically & USG at 10th day after surgery. | â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days | after surgery. | â— To compare the short-term recurrence (6 months).
â— To compare the short-term recurrence (6 months).
时间窗: â— To compare the incidence of development of seroma formation among the three | procedures at 48 hours & 5th day clinically & USG at 10th day after surgery. | â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days | after surgery. | â— To compare the short-term recurrence (6 months).
â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days
时间窗: â— To compare the incidence of development of seroma formation among the three | procedures at 48 hours & 5th day clinically & USG at 10th day after surgery. | â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days | after surgery. | â— To compare the short-term recurrence (6 months).
after surgery.
时间窗: â— To compare the incidence of development of seroma formation among the three | procedures at 48 hours & 5th day clinically & USG at 10th day after surgery. | â— To compare the severity of pain using VAS score at 48 hours, 5 days and 10 days | after surgery. | â— To compare the short-term recurrence (6 months).
次要结局
- To compare the operative time in minutes, among the three procedures.(â— To compare the duration of hospital stay in days, among the three procedures.)