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临床试验/CTRI/2024/10/075238
CTRI/2024/10/075238尚未招募2/3 期

Randomised control trial comparing pain, quality of life and cost between laparoscopic ventral transabdominal preperitoneal (vTAPP) plus vs. intraperitoneal onlay mesh (IPOM) plus repair for primary ventral hernia

Dr Aditya Kumar1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2024年10月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
1. To compare post-operative pain scores using the visual analogue scale (VAS) score

研究概览

简要总结

Primary ventral hernia repair is a common surgical procedure, but the optimal technique for achieving the best outcomes remains a topic of ongoing debate. The standard technique, Intraperitoneal Onlay Mesh (IPOM) plus, has been widely used and studied. Although it is technically easy to perform, presence of an intraperitoneal mesh and use of tackers has potential to cause life threatening complications such as severe post-operative pain, adhesive intestinal obstruction, fistulas and abscess. Besides this, as the mesh is placed intra-peritoneally, a composite (dual layered) mesh is needed and tacking devices to fix the mesh. This leads to increased costs when compared to use of a single layered polypropylene mesh without need for tackers. These reasons eventually impact on the patients’ quality of life in the long term. Due to these reasons, attempts have been made to develop other techniques which allow placement of mesh outside the peritoneal cavity and remove the need to use fixation devices. Some surgeons are employing techniques, which place mesh in the retrorectus space, however, they need extensive dissection and division of the natural structures such as the posterior rectus sheath, which may have potential to cause hernia recurrence on the long run. Hence, attempts have been made to place the mesh in the pre- peritoneal space trans-abdominally. This technique of ventral transabdominal pre-peritoneal repair (vTAPP) is derived from the transabdominal preperitoneal repair (TAPP) used for inguinal hernia repairs routinely. The technique prevents use of intraabdominal mesh, avoids the need for fixation devices such as tackers and avoids the use of a composite mesh. Thereby, reducing product cost and avoiding the potential complications, especially severe pain, adhesions and fistula formation. However, these techniques are technically difficult to perform. Some retrospective studies are available in literature with conflicting results. Hence, we designed this randomized controlled trial comparing Laparoscopic vTAPP Plus versus the standard IPOM Plus for Ventral Hernia Repair in terms of outcomes, quality of life and cost effectiveness.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Primary midline ventral hernia
  • Hernia defect size 2 – 5 cm
  • Able to tolerate general anesthesia
  • Patients provide written consent to be enrolled in the trial.

排除标准

  • Incisional hernia
  • Multiple hernias
  • Complicated hernia (Obstruction, Strangulation)
  • Age less than 18 years
  • Emergency surgery.

结局指标

主要结局

1. To compare post-operative pain scores using the visual analogue scale (VAS) score

时间窗: early (6hours, 24 hours and at discharge) and late (3 to 6 months)

2.To evaluate early quality of life

时间窗: early (6hours, 24 hours and at discharge) and late (3 to 6 months)

scores using European Registry of Abdominal Wall Hernias Quality of Life (EuraHS-QoL)

时间窗: early (6hours, 24 hours and at discharge) and late (3 to 6 months)

次要结局

  • 1. To compare total post operative analgesics dose

研究者

发起方
Dr Aditya Kumar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Aditya Kumar

ALL INDIA INSTITUTE OF MEDICAL SCIENCES DELHI

研究点 (1)

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