Comparison of Biportal Versus Multiportal Robotic Approaches for Pulmonary Resection in NSCLC (EC-UMUR)
Clinical Trial in Patients With Non-Small Cell Lung Cancer Undergoing Biportal Versus Multiportal Robotic Thoracic Surgery: Comparison of Two Innovative Techniques
연구 개요
상태
정황
상세 설명
Robotic-assisted thoracic surgery is widely used for pulmonary resection in patients with resectable non-small cell lung cancer. Multiportal RATS uses several access ports. Biportal RATS uses two access incisions and aims to preserve minimally invasive benefits while improving ergonomic access and instrument maneuverability.
This single-center, prospective, randomized, partially blinded clinical trial will compare biRATS with multiRATS in adults undergoing pulmonary resection with curative intent at Hospital Universitari de Bellvitge. Eligible participants who provide written informed consent will be randomly assigned using the study REDCap randomization system. A standardized dressing will be maintained for 48 hours after surgery to support partial blinding.
The main analysis will compare intraoperative and immediate postoperative complications between groups. Additional assessments include intraoperative blood loss, conversion, chest-drain duration, hospital length of stay, postoperative pain, readmission, mortality, and health-related quality of life. Quality of life will be assessed using EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13; pain will be measured with a visual analogue scale and DN4 questionnaire. Follow-up occurs during hospitalization and at 1, 6, and 12 months after surgery.
The planned sample is 70 to 80 participants (approximately 35 per group). The study is investigator initiated and has CEIm approval (PR208/24; protocol version 3.0 dated June 18, 2025).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Carlos Déniz Armengol, MD, PhD
- 전화번호: 2744 +34 932607500
- 이메일: cjdeniz@bellvitgehospital.cat
연구 장소
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, 스페인, 08907
- 모병
- Hospital Universitari de Bellvitge
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연락하다:
- Carlos Déniz Armengol, MD, PhD
- 전화번호: 2744 +34 932607500
- 이메일: cjdeniz@bellvitgehospital.cat
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 years or older, of any sex.
- Non-small cell lung cancer considered clinically resectable, confirmed preoperatively or during surgery.
- Candidate for pulmonary resection by robotic thoracic surgery.
- Written informed consent.
Exclusion Criteria:
- Declines participation or cannot provide written informed consent.
- Thoracic anatomical abnormalities that preclude or materially affect robotic surgery.
- Active thoracic infection.
- Surgery not performed by a participating surgeon with comparable experience in biRATS and multiRATS.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: biRATS
Biportal robotic-assisted thoracic surgery for pulmonary resection using two access incisions.
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Pulmonary resection performed with a biportal robotic-assisted thoracic surgery approach using two access incisions.
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활성 비교기: multiRATS
Multiportal robotic-assisted thoracic surgery for pulmonary resection using multiple access ports.
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Pulmonary resection performed with a multiportal robotic-assisted thoracic surgery approach using multiple access ports.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Intraoperative and Immediate Postoperative Complications
기간: From surgery through hospital discharge, up to 30 days
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Proportion of participants with intraoperative or immediate postoperative complications, classified by Clavien-Dindo grade.
Events include, among others, prolonged air leak, pleuropulmonary infection, pneumothorax, postoperative hemorrhage, chylothorax, respiratory failure, wound infection, readmission, and perioperative death.
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From surgery through hospital discharge, up to 30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intraoperative Blood Loss
기간: During surgery
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Estimated intraoperative blood loss in milliliters.
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During surgery
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Length of Hospital Stay
기간: From surgery through hospital discharge, up to 30 days
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Number of days from surgery to medical discharge.
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From surgery through hospital discharge, up to 30 days
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Postoperative Pain Intensity (Visual Analog Scale)
기간: From baseline through 12 months after surgery
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Pain intensity measured using the Visual Analog Scale (VAS), a 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
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From baseline through 12 months after surgery
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Neuropathic Pain (Douleur Neuropathique 4 Questionnaire)
기간: From baseline through 12 months after surgery
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Neuropathic pain assessed using the Douleur Neuropathique 4 (DN4) questionnaire, scored from 0 to 10. Scores of 4 or higher are consistent with neuropathic pain; higher scores indicate a greater likelihood of neuropathic pain.
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From baseline through 12 months after surgery
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Health Status (EuroQol 5-Dimension 5-Level Questionnaire)
기간: From baseline through 12 months after surgery
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Health status assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) descriptive system.
Five dimensions are each rated from 1 (no problems) to 5 (extreme problems); lower levels indicate better health status.
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From baseline through 12 months after surgery
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Global Health Status/Quality of Life (EORTC QLQ-C30)
기간: From baseline through 12 months after surgery
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Global health status/quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/QoL scale, transformed to a 0 to 100 score; higher scores indicate better global health status/quality of life.
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From baseline through 12 months after surgery
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Patient-Reported Lung Cancer Symptoms (EORTC QLQ-LC13)
기간: From baseline through 12 months after surgery
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Lung cancer-related symptoms assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13).
Symptom scores are transformed to 0 to 100; higher scores indicate greater symptom burden.
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From baseline through 12 months after surgery
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Postoperative Healthcare Procedures
기간: From surgery through hospital discharge, up to 30 days
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Number of additional medical procedures required during the index hospitalization, including chest-drain management interventions.
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From surgery through hospital discharge, up to 30 days
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Carlos Déniz Armengol, MD, PhD, Hospital Universitari de Bellvitge
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
- HUB-CTO-2024-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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