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临床试验/NCT07337603
NCT07337603已完成不适用

The Effect Of Trans-Anbdominal Pre-Peritoneal (TAPP) And Total Extra-Peritoneal (TEP) Procedures on Intraocular Pressure in Laparoscopıc Inguinal Hernia Repair :A Procspective Cohort Study

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
TAPP procedure effects intraocular pressure

研究概览

简要总结

Inguinal hernia is a common clinical condition, accounting for approximately 75% of abdominal wall hernias. The inguinal hernia surgery is one of the most common operations worldwide. The primary treatment for inguinal hernia is surgical options. In addition to the standard open surgical approach, the Lichtenstein technique, laparoscopic methods such as transabdominal preperitoneal (TAPP) and total extraperitoneal (TEP) approaches are currently the most commonly used surgical procedures.

Both methods result in less postoperative pain, seroma, chronic pain, hematoma, and wound infection compared to the Lichtenstein technique.

Many surgeons use the Trendelenburg position, approximately 30 to 45 degrees, when performing laparoscopic procedures. The advantage of the Trendelenburg position is that it allows for better visualization of the abdominal and pelvic organs and creates space for the operation. However, the Trendelenburg position also has some complications, such as increasing intraocular pressure. Also, in laparoscopic surgeries, pneumoperitoneum is created by introducing CO₂ gas into the abdomen. This increases intra-abdominal pressure, causing the diaphragm to be pushed upward and raising thoracic pressure. As a result, central venous pressure increases and intracranial venous return becomes difficult, which can lead to a temporary increase in intraocular pressure. Perioorbital swelling and venous congestion caused by prolonged surgery time and the position used can cause compartment syndrome in the orbital space and even lead to vision loss.

The current literature indicates that the increase in intra-abdominal pressure during laparoscopic surgery, the patient's position, and the surgery time can lead to an increase in intraocular pressure.

详细描述

Inguinal hernia is a common clinical condition, accounting for approximately 75% of abdominal wall hernias. It is more common in men than women, affecting approximately 25% of men and 2% of women throughout their lifetime. Due to its frequent occurrence, inguinal hernia surgery is one of the most common operations worldwide. The incidence of inguinal hernia shows a bimodal distribution, with the highest incidence occurring around the age of 5 and over 70. Two-thirds of these hernias are indirect hernias.

Many previous studies have identified several risk factors in its etiology, including advanced age, male gender, smoking, family history, conditions causing intra-abdominal pressure, and collagen connective tissue diseases.

The most fundamental point in diagnosing inguinal hernia is physical examination. Physical examination is the easiest and most accurate way to diagnose the hernia. However, while most inguinal hernias are diagnosed by physical examination, radiological examination may be necessary in cases where the body structure prevents physical examination. Radiological methods include ultrasonography, computed tomography and rarely magnetic resonance imaging.

The primary treatment for inguinal hernia is surgical options. In addition to the standard open surgical approach, the Lichtenstein technique, laparoscopic methods such as transabdominal preperitoneal (TAPP) and total extraperitoneal (TEP) approaches are currently the most commonly used surgical procedures.

The most frequently used laparoscopic treatment methods worldwide are TAPP and TEP procedures. In both methods, mesh is placed in the preperitoneal space, but in the TAPP technique, it is necessary to enter the abdominal cavity to place the mesh. In the TEP procedure, all procedures are performed without opening the peritoneal wall and without entering the abdomen.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being over 18 years of age
  • Having been diagnosed with inguinal hernia
  • Those wishing to participate in the study

排除标准

  • Patients under 18 years of age
  • Patients diagnosed with glaucoma
  • Patients with rheumatological diseases (rheumatoid arthritis, SLE, etc.)
  • Patients with chronic kidney and liver failure
  • Patients who have undergone corneal transplantation
  • Patients with malignancy
  • Patients diagnosed with bilateral inguinal hernia
  • Patients with ocular trauma
  • Myopia or hyperopia exceeding three diopters
  • Patients using systemic steroids
  • Body Mass Index > 30 kg/m2
  • Those who do not wish to participate in the study

研究组 & 干预措施

TAPP Group

Planned groin hernia patients who will operated with Transabdominal Preperitoneal technique

干预措施: Preoperative Intraocular Pressure (Other)

TAPP Group

Planned groin hernia patients who will operated with Transabdominal Preperitoneal technique

干预措施: Postoperative Intraocular Pressure (Other)

TEP GRoup

Planned groin hernia patients who will operated with Trans Extra-Preperitoneal technique

干预措施: Preoperative Intraocular Pressure (Other)

TEP GRoup

Planned groin hernia patients who will operated with Trans Extra-Preperitoneal technique

干预措施: Postoperative Intraocular Pressure (Other)

结局指标

主要结局

TAPP procedure effects intraocular pressure

时间窗: Preooeratively and postoperative first day

Preooeratively and postoperatively measured intraocular pressure with Goldmann's aplanasyon tonometry

TEP procedure effects intraocular pressure

时间窗: Preooeratively and postoperative first day

Preooeratively and postoperatively measured intraocular pressure with Goldmann's aplanasyon tonometry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Buğra Bozan

Professor, Associate MD

Saglik Bilimleri Universitesi

研究点 (1)

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