跳至主要内容
临床试验/NCT07755696
NCT07755696招募中不适用

Combined APProach of Umbilical ConComitant With Inguinal Hernia

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月1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
30
试验地点
1
主要终点
Technical errors with the robotic system

研究概览

简要总结

Evaluation of the perioperative and patient reported outcomes of a new surgical technique: robotic inguinal hernia repair using the Da Vinci SP system.

详细描述

The CAPPUCCINOH study (Combined APProach of Umbilical ConComitant with Inguinal Hernia Repair) is a prospective single-centre, single-arm cohort study conducted at AZ Maria Middelares, Ghent, Belgium. The study evaluates a novel surgical technique combining robotic-assisted inguinal hernia repair with concomitant umbilical hernia repair using the da Vinci Single Port (SP) system.

Building on the feasibility demonstrated in the ESPRITH study, the umbilical hernia defect is used as the single access site for the robotic procedure. Following inguinal hernia repair, the umbilical defect is repaired either by primary closure or with preperitoneal mesh reinforcement according to current guidelines and defect size.

The primary objective is to assess the safety and feasibility of this approach by evaluating operative time, technical errors, successful mesh placement, and perioperative complications. Secondary objectives include assessment of patient-reported outcomes, quality of life, body image, and hernia recurrence at one year postoperatively.

Patients will be followed for one year after surgery, with evaluations performed during hospitalization and at one month and one year postoperatively. The study aims to generate clinical evidence on the safety, effectiveness, and patient experience of robotic single-port repair for concomitant inguinal and umbilical hernias.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •Adults with a primary inguinal hernia, either unilateral or bilateral, in association with a primary umbilical hernia of >1

排除标准

  • •recurrent inguinal hernia after preperitoneal repair
  • •irreducible scrotal hernia
  • •post-prostatectomy
  • •laparotomy in the lower abdomen
  • •pregnancy
  • •contra-indication for general anaesthesia

研究组 & 干预措施

Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair

Experimental

干预措施: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair (Procedure)

Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair

Experimental

干预措施: da Vinci Single Port Surgical System (Device)

结局指标

主要结局

Technical errors with the robotic system

时间窗: During surgery

Number and type of technical errors or device-related issues encountered during the procedure.

Operative time

时间窗: During surgery

Total operative time from skin incision to skin closure

Complication Rate

时间窗: From surgery until 1 month postoperatively

Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification

Success rate

时间窗: From surgery until planned follow-up 1 month potoperatively

success rate of preperitoneal mesh placement

次要结局

  • Body Image Questionnaire Score(Preoperatively, 1 month , and 1 year postoperatively)
  • EuraHS Quality of Life score(Preoperatively, 1 month and 1 year postoperatively)
  • Number of Participants With Hernia Recurrence(1 year postoperatively)

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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