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临床试验/NCT05939206
NCT05939206已完成不适用

rTARUP (Robotic-assisted Transabdominal Retromuscular Umbilical Prosthetic Repair): Long-term Analysis of More Than 48 Months

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2023年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
111
试验地点
1
主要终点
Hernia recurrence

研究概览

简要总结

The aim of the study is to assess the recurrence rate and potential long-term complications, at least 48 months, after a robotic assisted transabdominal retromuscular approach (rTARUP technique) for the repair of an umbilical hernia.

详细描述

The rTARUP technique (robotic assisted transabdominal retromuscular umbilical prosthetic repair) has been introduced in the latest years for the treatment of ventral/umbilical hernias. Short-term analyses have proven that this technique can be performed safely and without complications. The technique maintains the benefits of a traditional laparoscopic approach (smaller incision, faster recovery, shorter hospital stay) and obeys mesh complications related to intraperitoneal mesh placement (adhesions, pain due to mesh fixation). An initial evaluation was conducted at our center to assess recurrence and complications 1 year after the procedure in a patient group of 203 patients. We documented 3 patients with a recurrence of which 2 of them had a laparoscopic intra-peritoneal hernia repair to treat the recurrence. Due to Covid-19 restrictions a clinical follow-up was only possible in 73% of patients. Therefore, we believe that a longer follow-up period of at least 48 months after surgery is necessary and surgically relevant to analyze the primary (recurrence rate) and secondary (long-term complications) end points of the recently introduced rTARUP technique for the treatment of ventral/umbilical hernias.

Muysoms, F., et al., Robotic transabdominal retromuscular umbilical prosthetic hernia repair (TARUP): observational study on the operative time during the learning curve. Hernia, 2018. 22(6): p. 1101-1111.

Muysoms, F., et al., Observational study with one year follow-up on robotic assisted retro-rectus ventral hernia repair (RTARUP) with a self-fixating mesh. Br J Surg, 2021. 108(Suppl 8).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients that underwent rTARUP procedure in the period September 2016 - December 2019
  • Lateral approach to the retromuscular plane/lateral single docking
  • Use of Progrip self-fixating mesh

排除标准

  • Ventral hernia on the lateral side or combined hernia (lateral and medial)
  • eTEP approach to the retromuscular plane
  • Use of any other mesh than Progrip self-fixating mesh.

结局指标

主要结局

Hernia recurrence

时间窗: After at least 48 months post-operative

Hernia recurrence

次要结局

  • Long-term complications(After 48 months post-operative)
  • Quality of Life Questionnaire(After 48 months post-operative)

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

MD

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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