The Effect of Hernia Belt on Postoperative Complications and Quality of Life for Patients Who Underwent Laparoscopic Inguinal Hernia Repair:a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 678
- 试验地点
- 1
- 主要终点
- Health-related quality of life
研究概览
简要总结
In this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. Outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,VAS), health-related quality of life (36-item short-form health survey, SF-36). Follow up by physical examination, ultrasonography and telephone.
详细描述
Some scholars believe that the use of hernia belts to compress the inguinal region reduces postoperative complications. According to the International Guidelines for the Management of Inguinal Hernia in Adults (2018) interpretation, the incidence of seroma after inguinal hernia repair ranges from 0.5% to 2.2%. However,there is no consensus among different research organizations and clinical staff on the use of hernia belts after laparoscopic inguinal hernia repair. In this study, the investigators aimed to investigate the effect of hernia belt on postoperative complications and quality of life for patients who underwent laparoscopic inguinal hernia repair. Outcomes include hernia recurrence (patient-reported and clinical exam), postoperative complications within 3 months (seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation), pain (visual analog scale,VAS), health-related quality of life (36-item short-form health survey, SF-36). Follow up by physical examination, ultrasonography and telephone.
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
- None
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
- •18 years or order.
- •Primary unilateral oblique inguinal hernia, direct hernia, femoral hernia.
- •Qualified for laparoscopic Transabdominal preperitoneal approach(TAPP) or Totally extraperitoneal(TEP).
- •Eligible to tolerate general anesthesia.
排除标准
- •Incarcerated hernia, recurrent hernia and other types of hernia.
- •Patients presenting for obvious contraindications to surgery.
- •Need for an open inguinal hernia repair.
- •Difficult to follow-up or communication.
- •Patients who are unable to give informed consent.
研究组 & 干预措施
Hernia belt compressing group
Patients were given hernia belt compression of the inguinal region after laparoscopic inguinal hernia repair surgery in the operating room. The silicone pad of the hernia belt was placed in the inguinal region of the surgical side for compression for a period of 2 weeks.
干预措施: Hernia belt compression (Procedure)
No hernia belt compressing group
Patients were should not have the intervention "Hernia belt compression" .
结局指标
主要结局
Health-related quality of life
时间窗: 1 day,7 days,1 month and 3 months after surgery.
The 36-item short-form health survey(SF-36) was adopted for Health-related quality of life 1 day, 7 days, 1 months and 3 months postoperatively. SF-36 consists of 36 articles, including 8 areas of physical function, physical role, physical pain, general health status, vitality, social function, emotional role and mental health.
Pain score
时间窗: 1 day,7 days,1 month and 3 months after surgery.
The visual analog scale (VAS) was adopted for pain evaluation preoperative,1 day, 7 days, 1 months and 3 months postoperatively.The scale range from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain.Higher scores mean a worse outcome.
Hernia recurrence
时间窗: 1 month,3 months,6 months and 12 months after surgery.
Follow up by physical examination, ultrasonography and telephone at 1 month,3 months,6 months and 12 months after surgery about the rate of hernia recurrence.
Postoperative complications
时间窗: Within 3 months after surgery.
Including seroma and hematoma development, wound infection, abdominal bloating and foreign body sensation,follow up by physical examination, ultrasonography and telephone.
次要结局
未报告次要终点
研究者
Yunhong Tian
Director of Gastrointestinal, Colorectal and Hernia Surgery
Nanchong Central Hospital