Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
This study aim to compare efficacy and safety of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.
详细描述
This is a prospective, double blinded, randomized trial. It compared of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.
Inguinal hernia is one of the most common surgical diseases. Laparoscopic hernia repairs include two types, TEP and TAPP. Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period and better cosmetic results. Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery.
200 patients will undergo TEP inguinal hernia repair. They will be randomized in two groups by sealed envelope method.
Group A: Standard TEP with 3 ports (10mm. and 2 ports of 5mm.). In case of difficulty in Standard 3 port TEP inguinal hernia repair, the procedure will be converted to TAPP.
Group B: LESS TEP with single skin incision 2-3cm. In case of difficulty in LESS TEP inguinal hernia repair, the procedure will be converted to standard 3 port repair or TAPP.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years
- •Willing to participate in this study and signed an informed consent.
- •Diagnosed inguinal hernia - primary or recurrence
- •ASA class I, II and III
排除标准
- •Age under 18 years and above 90 years
- •Strangulated hernia
- •Patients with severe chronic diseases or cardiopulmonary dysfunction, who can't undergo general anesthesia
- •Patients who prefer a certain surgical approach
- •Patients who undergo surgery procedures for chronic pain after inguinal hernia repair
研究组 & 干预措施
Standard 3 port TEP
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
干预措施: Standard 3 port TEP (Procedure)
LESS TEP
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
干预措施: LESS TEP (Procedure)
结局指标
主要结局
Postoperative Pain
时间窗: 1 week
Postoperative pain will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain intensity (worse outcome).
Postoperative Pain
时间窗: 24hours
Postoperative pain will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain intensity (worse outcome).
次要结局
- Operating time(During operation)
- Intraoperative complications(During operation)
- Recurrence of hernia(4 weeks; 3 months; 1 year)
- Postoperative complications(1 week; 4 weeks)
- Length of hospital stay(24 hours)
- Cosmetic scar score(4 weeks)
- Operating Time(During operation)
- Intraoperative Complications(During operation)
- Length of Hospital Stay(From end of surgery until hospital discharge (typically within 1-3 days postoperatively).)
- Postoperative Complications(Within 4 weeks postoperatively.)
- Recurrence of Hernia(During the entire follow-up period (up to 2 years))
- Patient Satisfaction(1 year)