跳至主要内容
临床试验/CTRI/2025/09/094274
CTRI/2025/09/094274尚未招募4 期

Comparison of Trans Abdominal Pre-peritoneal (TAPP) and Enhanced view Totally Extraperitoneal Rives Stoppa (e-TEP RS) repair for Primary Umbilical and Para umbilical Hernia – a Randomized Controlled Study

Rakshita1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Post-operative pain (using Numerical Rating Scale) on day 1 and 10 after the procedure

研究概览

简要总结

Ventral hernia of anterior abdominal wall is a common surgical problem due to any musculo-aponeurotic defect of anterolateral parietal abdominal wall through which protrusion of intra-abdominal or preperitoneal contents occurs. Midline primary hernias include epigastric, umbilical and paraumbilical hernias. Umbilical hernias occur due to conditions that cause stretching and thinning of the midline raphe (linea alba), such as in pregnancy, obesity, ascites and predisposes to reopening of umbilical defect. Paraumbilical hernias occur when a defect in linea alba is adjacent to the true umbilicus. In the current era, so many different options for the management of these hernias are available from various open to minimal invasive techniques, and these diversity of techniques makes the decision making more difficult in ventral hernias. The major advantage of laparoscopic hernia repair was the cosmetic benefit, early ambulation, less operative complications, less hospital stay, less blood loss and less chances of recurrence. The disadvantages of laparoscopic surgery included technical difficulty, use of general anesthesia and equipment cost. Minimal invasive procedures with different techniques and mesh positions have evolved rapidly in the last decade.The e-TEP technique is based on the principle that the extra peritoneal space can be created from almost anywhere in the anterior abdominal wall. Trans Abdominal Pre-Peritoneal technique involves the dissection of peritoneum off the posterior rectus sheath, with a mesh placed in the preperitoneal space. Both eTEP and TAPP are described in literature, but there is no direct comparison among the two techniques. Thus, this study will attempt to compare the short-term outcomes between eTEP and TAPP approaches to primary umbilical hernias and attempt to better define the indications for the two procedures.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Age between 18 to 65 years Defect size 1-4cm maximum transverse diameter, assessed clinically.

排除标准

  • Concurrent recuts diastasis of more than 2cm, measured at the umbilicus in supine position Complicated hernia (obstructed or strangulated) On anticoagulants other than aspirin Obese patients (BMI of 35 or higher) Pregnancy and lactation.

结局指标

主要结局

Post-operative pain (using Numerical Rating Scale) on day 1 and 10 after the procedure

时间窗: Post-operative pain (using Numerical Rating Scale) on day 1 and 10 after the procedure

次要结局

  • Mean operative time (time in minutes from skin incision to skin closure)(Proportion of patients with complications (seroma / hematoma formation, infection) within one month of surgery)

研究者

发起方
Rakshita
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

RAKSHITA

Maulana Azad Medical College

研究点 (1)

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