A Randomized Controlled Trial Comparing Modified Tumescent vs. Conventional Laparoscopic TAPP for Inguinal Hernia Repair
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Pain Score
概览
简要总结
This study aims to compare the outcomes of two laparoscopic techniques for repairing inguinal hernias: the modified tumescent technique (MT-TAPP) and the conventional laparoscopic transabdominal preperitoneal technique (CL-TAPP). The primary goal is to determine which technique provides better outcomes in terms of operative time, ease of pre-peritoneal space dissection, postoperative pain, and the formation of seromas. The study will involve 60 patients diagnosed with unilateral inguinal hernias, randomly assigned to either group. Participants in Group A will undergo the MT-TAPP procedure, which involves pre-peritoneal infiltration of a local anesthetic solution to improve dissection and reduce pain. Group B will undergo the standard CL-TAPP procedure. Data will be collected on various outcome measures and analyzed to identify which technique leads to quicker recovery, less postoperative pain, and fewer complications. The results of this study will help guide surgical decisions and improve patient outcomes in inguinal hernia repair.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 50 years.
- •Gender: Both male and female participants.
- •Condition: Diagnosed with unilateral inguinal hernia (as per operational definition).
- •Health Status: ASA I-III (American Society of Anesthesiologists physical status classification), indicating that the patient is fit for surgery.
- •Consent: Participants must be able to provide informed consent to participate in the study.
排除标准
- •Femoral Hernias.
- •Incarcerated or Strangulated Hernia.
- •Recurrent Hernias (as per medical record).
- •Serious Systemic Diseases:
- •Conditions such as heart failure or coagulation problems (e.g., PT \> 15 sec).
- •ASA III-V classification, indicating a higher risk for surgery.
- •Pregnancy (if applicable).
- •Allergy to Anesthesia or the substances used in the tumescent solution (lidocaine, epinephrine, saline).
- •Uncontrolled Diabetes or other medical conditions that might interfere with the healing process.
研究组 & 干预措施
Modified Tumescent Laparoscopic TAPP (MT-TAPP)
干预措施: Modified Tumescent Laparoscopic TAPP (MT-TAPP) for the first group. (Other)
Conventional Laparoscopic TAPP (CL-TAPP)
干预措施: Conventional Laparoscopic TAPP (CL-TAPP) (Other)
结局指标
主要结局
Pain Score
时间窗: Recorded 24 hours post-surgery.
A score of 0 represents no pain, while a score of 10 represents the worst pain.
Seroma Formation:
时间窗: Presence or absence of seroma, assessed during the 7-day postoperative follow-up.
次要结局
未报告次要终点
研究者
Taseen Imran
Principal Investigator
University of Health Sciences Lahore