Investigate whether the usage of pre-operative projections prior to a deep inferior epigastric perforator flap breast reconstruction leads to more correctly identified perforator locations and less operation time spend on dissecting the free skin…
ID
Bron
Aandoening
Borstreconstructie breastreconstruction DIEP flap
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of preoperatively identified perforators found intraoperatively (true positive) in each flap<br>
Time elapsed on dissecting the free skin flap
Achtergrond van het onderzoek
Rationale: In a Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction, a large part of the abdominal fat and skin below the navel is used to form a new breast. The flap relies on blood supply provided by perforators, which are very small in diameter and difficult to detect during the procedure. If a perforator is accidentally severed, the procedure becomes compromised. Prior to surgery a CT scan is made and a handheld Doppler US device is used to indicate the perforator locations on the patients abdomen. This method does not distinguish main axial vessels from perforator arteries at the height of the fascia, cannot assess the deep inferior arteries branching patterns and has a limited penetration depth although essential for obese patients. To overcome this problem we developed an innovative method that consist of a projection system, capable of projecting anatomical data onto the patient. Using the already acquired CT data for vascular assessment, a virtual navigational map for the procedure is created. This map containing the perforator locations, intramuscular trajectory and optionally other anatomical features is projected onto the patient prior to surgery and traced with a marker pen.
We expect shorter preoperative examination times and more intraoperatively relevant information for the surgeon. To investigate this, the harvesting time of the flap and total surgery time will be recorded. Intraoperative complications such as perforator destruction and post-operative complications will be noted. In literature, high surgeon stress has been reported. In this study we also assess the surgeons' task load through a verified checklist developed by NASA named Task Load Index (TLX).
Objective:
Primary Objectives:
Investigate whether the usage of pre-operative projections prior to a deep inferior epigastric perforator flap breast reconstruction leads to more correctly identified perforator locations and less operation time spend on dissecting the free skin flap compared to the currently used planning method.
Secondary Objectives:
To investigate whether preoperative planning can accurately predict perforators used intraoperatively. To assess the impact of the different planning techniques on the task load of performing the surgery. To evaluate morbidity including fat necrosis, partial or total flap loss, arterial thrombosis, venous congestion and perforator destruction between both groups. To gain insight into the total procedure time.
Study design: Randomized controlled trial, open label
Study population: Age 18 years of older. Patients scheduled for direct, delayed, unilateral or bilateral deep inferior epigastric perforator flap breast reconstruction surgery. Patients willing to participate (written informed consent).
Intervention (if applicable): The control group receives standard care; perforator location planning through US Doppler. The projection group receives additional planning based on CT data and the perforator locations are displayed on the abdomen
Main study parameters/endpoints:
The proportion of correctly and incorrectly identified perforators found with both techniques, compared to intraoperative results in each harvested flap (true positives). The total harvest time for each flap.
Countries of recruitment: Netherlands
Doel van het onderzoek
Investigate whether the usage of pre-operative projections prior to a deep inferior epigastric perforator flap breast reconstruction leads to more correctly identified perforator locations and less operation time spend on dissecting the free skin flap compared to the currently used planning method.
Onderzoeksopzet
Pre, intra- and postoperative
Onderzoeksproduct en/of interventie
Localizing perforator locations through handheld Doppler US
or
Localizing perforator locations using a projection based on CTA
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Age 18 years of older.
Patients scheduled for direct, delayed, unilateral or bilateral deep inferior epigastric perforator flap breast reconstruction surgery.
Patients willing to participate (written informed consent).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients with intolerance / hypersensitivity to contrast agent Iomeron (iomeprol)
Patients with inadequate kidney function (due to contrast agent)
Patients who undergo a deep inferior epigastric perforator flap with additional lymph node transfer.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL5807 |
NTR-old | NTR5962 |
CCMO | NL52994.091.15 |
OMON | NL-OMON42586 |