Robotic Single Port Combined Umbilical and Inguinal Hernia Repair (CAPPUCCINOH)
Combined APProach of Umbilical ConComitant With Inguinal Hernia
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Filip Muysoms, MD, PhD
- 전화번호: +32477325710
- 이메일: filip.muysoms@gmail.com
연구 연락처 백업
- 이름: Jolien Lansens, Sc
- 전화번호: +3292461854
- 이메일: Jolien.Lansens@mijnziekenhuis.be
연구 장소
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East-Flanders
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Ghent, East-Flanders, 벨기에, 9000
- 모병
- AZ Maria Middelares
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연락하다:
- Filip Muysoms, MD, PhD
- 전화번호: +32477325710
- 이메일: filip.muysoms@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Technical errors with the robotic system
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Image Questionnaire Score
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CAPPUCCINOH
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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