Robotic Single Port Combined Umbilical and Inguinal Hernia Repair (CAPPUCCINOH)
Combined APProach of Umbilical ConComitant With Inguinal Hernia
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Filip Muysoms, MD, PhD
- Telefonnummer: +32477325710
- E-mail: filip.muysoms@gmail.com
Undersøgelse Kontakt Backup
- Navn: Jolien Lansens, Sc
- Telefonnummer: +3292461854
- E-mail: Jolien.Lansens@mijnziekenhuis.be
Studiesteder
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East-Flanders
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Ghent, East-Flanders, Belgien, 9000
- Rekruttering
- AZ Maria Middelares
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Kontakt:
- Filip Muysoms, MD, PhD
- Telefonnummer: +32477325710
- E-mail: filip.muysoms@gmail.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Robotic Single-Port Inguinal and Concomitant Umbilical Hernia Repair
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Technical errors with the robotic system
Tidsramme: During surgery
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Number and type of technical errors or device-related issues encountered during the procedure.
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During surgery
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Operative time
Tidsramme: During surgery
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Total operative time from skin incision to skin closure
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During surgery
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Complication Rate
Tidsramme: From surgery until 1 month postoperatively
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Intraoperative, in-hospital and postoperative complications classified according to the Clavien-Dindo classification
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From surgery until 1 month postoperatively
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Success rate
Tidsramme: From surgery until planned follow-up 1 month potoperatively
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success rate of preperitoneal mesh placement
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From surgery until planned follow-up 1 month potoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Body Image Questionnaire Score
Tidsramme: Preoperatively, 1 month , and 1 year postoperatively
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Patient-reported body image assessed using the Body Image Questionnaire.
The questionnaire evaluates patient satisfaction with physical appearance and cosmetic outcomes
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Preoperatively, 1 month , and 1 year postoperatively
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EuraHS Quality of Life score
Tidsramme: Preoperatively, 1 month and 1 year postoperatively
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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
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Preoperatively, 1 month and 1 year postoperatively
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Number of Participants With Hernia Recurrence
Tidsramme: 1 year postoperatively
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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.
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1 year postoperatively
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CAPPUCCINOH
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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