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临床试验/NCT03904888
NCT03904888招募中不适用

Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
change in PADSS score

研究概览

简要总结

Evaluate the early postoperative course of patients undergoing laparoscopic inguinal hernia repair with either a conventional or a robot assisted approach and with or without the injection of the trocar wounds with a local anesthetic.

详细描述

Introduction Inguinal hernia is a common disease with a high lifetime risk; 27 % for men and 3% for women. These hernias can be categorized as lateral, medial or femoral according to the classification of the European Hernia Society. The manifestations may vary from an asymptomatic swelling till an incarcerated or strangulated hernia requiring an urgent operation.

The introduction of mesh reinforcement for groin hernia repair has resulted in reducing the rate of recurrences and chronic pain. Moreover, laparoscopic repair techniques made it possible to place the mesh in de pre-peritoneal space by a transperitoneal (TAPP) or pre-peritoneal (TEP) approach. These minimally invasive techniques are not only associated with less chronic pain or numbness, but also with an earlier return to normal activities or work. A favor for one of the two techniques has not yet been proven.

At the Hernia Center Maria Middelares a laparoscopic transabdominal pre-peritoneal (l-TAPP) approach is favored in the majority of adult patients presenting with a groin hernia since more than 20 years. The investigators have adopted a technique using one large pre-peritoneal self-fixating mesh that covers both groins in bilateral laparoscopic repairs. In September 2016 the investigators started to use a robot assisted laparoscopic approach (r-TAPP) for groin hernia repair and built proficiency in this technique with 120 cases operated in the first year of adoption. Barriers to adopting robot assisted groin hernia repair are insufficient availability of the robot, perception of longer operative time, perceived lack of clinical benefit for the patient and increased cost for instrumentation.

In a learning curve study using the daVinci Xi robotic system the investigators have shown that after about 25 cases the skin to skin operating time for r-TAPP equals the skin to skin operating time for l-TAPP. Similarly the overall OR time (patient in and out of the OR) is not increased for r-TAPP compared to l-TAPP if the whole team including nurses and anesthetists have become proficient in robotic assisted surgery (Clinical Trials identifier: NCT0975401).

The investigators standard technique for repair of bilateral groin hernias is to use a self-fixating mesh placed in a pre-peritoneal position with a TAPP approach. The investigator prefers to use one large mesh covering the myopectineal orifice of both groins with a width of 28 cm and a length of 13 cm. The mesh used is a Progrip self-fixating mesh (Medtronic, US), which is a monofilament polyester mesh to which resorbable PLA grips have been added to fixate the mesh to the underlying tissue during the period of mesh ingrowth and incorporation. This technique has been studied in our department in a prospective study focusing on early and one year outcome and has shown favorable results (Clinical Trials identifier: NCT02525666 ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •adult patients presenting with a bilateral inguinal hernia planned for a minimal invasive laparoscopic repair

排除标准

  • •Age below 18 years
  • •unilateral groin hernia repair
  • •incarcerated hernias
  • •open hernia repair
  • •no informed consent
  • •pregnant women
  • •ASA score 4 or more
  • •patient included in another study.

研究组 & 干预措施

l-TAPP with local anesthetics

Other

These patients will undergo a laparoscopic surgery with local anaesthetics.

干预措施: local anesthetics (Procedure)

r-TAPP without local anesthetics

Other

These patients will undergo a robot-assisted surgery without local anaesthetics.

干预措施: r-TAPP (Procedure)

r-TAPP with local anesthetics

Other

These patients will undergo a robot-assisted surgery with local anaesthetics.

干预措施: r-TAPP (Procedure)

r-TAPP with local anesthetics

Other

These patients will undergo a robot-assisted surgery with local anaesthetics.

干预措施: local anesthetics (Procedure)

l-TAPP without local anesthetics

Other

These patients will undergo a laparoscopic surgery without local anaesthetics.

干预措施: l-TAPP (Procedure)

l-TAPP with local anesthetics

Other

These patients will undergo a laparoscopic surgery with local anaesthetics.

干预措施: l-TAPP (Procedure)

结局指标

主要结局

change in PADSS score

时间窗: change of Baseline PADSS score up to 24h after surgery or unitl score is ≥ 9

Time postoperative for the patient to get fit for discharge as determined by a PADSS score (Post Anesthesia Discharge Scoring System) to reach ≥ 9 (10 is maximum). The score will be taken at 2 hourly intervals after surgery (0 hours,2 hours,4 hours,6 hours,8 hours,10 hours,12 hours,14 hours,16 hours,18 hours,20 hours,22 hours,24 hours) up to 24 hours or unitl score is ≥ 9.

次要结局

  • Quality of Life assessment: EuraHS Quality of Life questionnaire(1 month and 12 months post-operatively)
  • Recurrence rate(at 12 month)

研究者

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Muysoms

Head of Surgery Department

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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