|- candidate number||24609|
|- NTR Number||NTR5962|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jul-2016|
|- Secondary IDs||NL52994.091.15 |
|- Public Title||Advanced planning of DIEP flap patients|
|- Scientific Title||Advanced planning of DIEP flap patients|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Breast reconstruction|
|- Inclusion criteria||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).
|- Exclusion criteria||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.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-nov-2015|
|- planned closingdate||31-jul-2016|
|- Target number of participants||78|
|- Interventions||Localizing perforator locations through handheld Doppler US
Localizing perforator locations using a projection based on CTA
|- Primary outcome||Number of preoperatively identified perforators found intraoperatively (true positive) in each flap|
Time elapsed on dissecting the free skin flap
|- Secondary outcome||Number of preoperatively identified perforators not found intraoperatively (false positive) in each flap|
Number of preoperatively unidentified perforators found intraoperatively (false negative) in each flap
Number of correctly predicted perforators used in transplantation
Total time spent on performing the actual surgery (snijtijd)
Number of postoperative complications
Number of intraoperative complications
NASA TLX score to determine surgeon stress during procedure
|- Timepoints||Pre, intra- and postoperative|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| S Hummelink|
|- CONTACT for SCIENTIFIC QUERIES|| S Hummelink|
|- Sponsor/Initiator ||Radboud University Medical Center Nijmegen|
(Source(s) of Monetary or Material Support)
|Radboud University Medical Centre Nijmegen|
|- Brief summary||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).
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.
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
|- Main changes (audit trail)|
|- RECORD||11-jul-2016 - 30-aug-2016|