Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial) (VISION)
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)
연구 개요
상태
상세 설명
The VISION Trial is a prospective, multicentre, open-label, parallel-group randomised controlled trial comparing intraoperative indocyanine green (ICG) fluorescence angiography with standard clinical assessment for flap perfusion in head and neck free flap reconstruction.
Free flap reconstruction is an essential component of complex head and neck reconstruction, but flap survival depends on adequate microvascular perfusion. Conventional intraoperative assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination, provide indirect assessment of perfusion and may be unreliable in some situations.
ICG fluorescence angiography enables real-time visualisation of arterial inflow and venous outflow using near-infrared fluorescence imaging. Retrospective studies have suggested that ICG angiography may reduce rates of partial flap loss and flap-related re-exploration, but high-quality prospective randomised evidence remains limited.
A total of 244 adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects at participating Swedish centres will be included. Participants will be randomised to either standard clinical assessment alone or standard clinical assessment supplemented with intraoperative ICG fluorescence angiography.
In the intervention group, ICG angiography will be performed intraoperatively using near-infrared fluorescence imaging systems after administration of intravenous indocyanine green (Verdye®). Quantitative perfusion analysis will also be performed using SPY-Q software.
The primary endpoint is partial flap loss requiring intervention within 30 days after surgery. Secondary endpoints include total flap loss, flap-related re-exploration under general anaesthesia, flap salvage, postoperative complications graded according to Clavien-Dindo classification, and the association between intraoperative SPY-Q perfusion values and flap outcomes.
No additional trial-specific postoperative visits are required. Outcomes will be assessed through structured chart review at 30 and 90 days postoperatively.
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Pooya Rajabaleyan, MD, PhD
- 전화번호: +4640331000
- 이메일: Pooya.r@hotmail.com
연구 장소
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Malmö, 스웨덴
- Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.
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연락하다:
- Pooya Rajabaleyan, MD, PhD
- 전화번호: +4640331000
- 이메일: Pooya.r@hotmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥18 years at the time of inclusion
- Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area
- Ability to understand study information and provide written informed consent
Exclusion Criteria:
- Known allergy to indocyanine green or iodine
- Severe hepatic or renal impairment
- Confirmed or suspected pregnancy
- Breastfeeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Standard clinical assessment
Participants undergo intraoperative assessment of free flap perfusion using standard clinical assessment methods, including inspection of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated.
Surgical revision is performed according to standard clinical practice if inadequate perfusion is suspected.
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Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.
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실험적: Indocyanine Green Fluorescence Angiography
Participants undergo intraoperative assessment of free flap perfusion using indocyanine green (ICG) fluorescence angiography in addition to standard clinical assessment.
ICG is administered intravenously and perfusion is evaluated using near-infrared fluorescence imaging and SPY-Q quantitative perfusion analysis during head and neck free flap reconstruction.
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Standard intraoperative clinical assessment of free flap perfusion including evaluation of flap colour, capillary refill, tissue turgor, bleeding upon needle prick, and Doppler examination as clinically indicated during head and neck free flap reconstruction.
Indocyanine green (ICG) is administered intravenously during surgery for intraoperative fluorescence angiography assessment of free flap perfusion in head and neck reconstruction.
A 25 mg vial of ICG (Verdye®) is reconstituted with sterile water, and approximately 7.5 mg is administered intravenously followed by saline flush.
Perfusion is assessed using near-infrared fluorescence imaging systems and SPY-Q quantitative perfusion analysis.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Partial flap loss requiring intervention
기간: From index surgery to 30 days postoperatively
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Partial flap loss is defined as clinically evident flap necrosis requiring active therapeutic intervention, including operative debridement/revision in the operating room or bedside debridement/trimming performed by a surgeon beyond routine wound care.
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From index surgery to 30 days postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Total flap loss
기간: From index surgery to 30 days postoperatively
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Complete flap failure requiring flap removal, replacement, or abandonment with documentation of flap non-viability.
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From index surgery to 30 days postoperatively
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Flap-related re-exploration under general anaesthesia
기간: From index surgery to 30 days postoperatively
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Return to the operating room under general anaesthesia due to suspected or confirmed flap vascular compromise or flap viability concern, excluding planned second-look procedures without concern.
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From index surgery to 30 days postoperatively
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Flap salvage
기간: From index surgery to 30 days postoperatively
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Successful retention of the index flap following flap-related re-exploration for vascular compromise.
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From index surgery to 30 days postoperatively
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Postoperative complications
기간: From index surgery to 90 days postoperatively
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Incidence of postoperative complications occurring 90 days after index operation.
Predefined surgical complications will be captured systematically and include surgical takeback, partial flap loss, total flap loss, infection, hematoma or bleeding requiring intervention, fistula formation, wound dehiscence, seroma, abnormal wound healing, and other surgical complications.
The severity of complications will be classified according to the Clavien-Dindo Classification of Surgical Complications (Grade I-V, where Grade I represents the least severe complication and Grade V represents death).
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From index surgery to 90 days postoperatively
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Correlation between intraoperative SPY-Q Relative Perfusion Value (%) and partial flap loss
기간: From index surgery to 30 days postoperatively
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Correlation between intraoperative tissue perfusion measured using SPY-Q quantitative analysis software following indocyanine green fluorescence angiography and postoperative partial flap loss within 30 days after surgery.
SPY-Q Relative Perfusion Value is reported as a percentage ranging from 0% to 100%, where higher values indicate greater tissue perfusion.
Partial flap loss is assessed clinically and recorded as a binary outcome (present or absent).
The outcome measure is the correlation coefficient between SPY-Q Relative Perfusion Value and partial flap loss.
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From index surgery to 30 days postoperatively
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Pooya Rajabaleyan, MD, PhD, Region Skåne, Skånes universitetssjukhus, Sektion Plastikkirurgi, Malmö, Sverige
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-524710-29-00 (씨티스)
개별 참가자 데이터(IPD) 계획
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