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Robotic Single Port Combined Umbilical and Inguinal Hernia Repair (CAPPUCCINOH)

2026年8月20日 更新者:Filip Muysoms、Algemeen Ziekenhuis Maria Middelares

Combined APProach of Umbilical ConComitant With Inguinal Hernia

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

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • East-Flanders
      • Ghent、East-Flanders、比利时、9000
        • 招聘中
        • AZ Maria Middelares
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
Robotic surgical platform used to perform single-port robotic inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site.
Robotic single-port inguinal hernia repair with concomitant umbilical hernia repair through a single umbilical access site using the da Vinci SP system.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Technical errors with the robotic system
大体时间:During surgery
Number and type of technical errors or device-related issues encountered during the procedure.
During surgery
Operative time
大体时间:During surgery
Total operative time from skin incision to skin closure
During surgery
Complication Rate
大体时间:From surgery until 1 month postoperatively
Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
From surgery until 1 month postoperatively
Success rate
大体时间:From surgery until planned follow-up 1 month potoperatively
success rate of preperitoneal mesh placement
From surgery until planned follow-up 1 month potoperatively

次要结果测量

结果测量
措施说明
大体时间
Body Image Questionnaire Score
大体时间:Preoperatively, 1 month , and 1 year postoperatively
Patient-reported body image assessed using the Body Image Questionnaire. The questionnaire evaluates patient satisfaction with physical appearance and cosmetic outcomes
Preoperatively, 1 month , and 1 year postoperatively
EuraHS Quality of Life score
大体时间:Preoperatively, 1 month and 1 year postoperatively
Patient-reported quality of life assessed using the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) Questionnaire, a validated instrument evaluating pain at the hernia site, restriction of activities, and cosmetic discomfort. The total EuraHS-QoL score ranges from 0 to 90, with lower scores indicating better quality of life and less symptom burden, and higher scores indicating worse quality of life and greater symptom burden
Preoperatively, 1 month and 1 year postoperatively
Number of Participants With Hernia Recurrence
大体时间:1 year postoperatively
Number of participants with a recurrent ventral hernia within 1 year after surgery. Hernia recurrence will be assessed clinically and confirmed by ultrasound when clinically indicated.
1 year postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月1日

初级完成 (估计的)

2028年4月1日

研究完成 (估计的)

2029年4月1日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月5日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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