|- candidate number||3103|
|- NTR Number||NTR1245|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mrt-2008|
|- Secondary IDs||P07.261 METC LUMC|
|- Public Title||Solomon study|
|- Scientific Title||Fetoscopic laser coagulation of the entire vascular equator for the treatment of
twin-to-twin transfusion syndrome:
the "Solomon study"
|- hypothesis||To determine whether the ‘Solomon laser-technique’, in which the entire vascular equator is coagulated, reduces the prevalence of TAPS or recurrence of TTTS when compared to the ‘selective laser-technique’, in which only the identifiable vascular anastomoses are coagulated.|
|- Healt Condition(s) or Problem(s) studied||Fetoscopic laser surgery, Twin-to-twin transfusion syndrome (TTTS), Twin anemia-polycythemia sequence|
|- Inclusion criteria||1. All TTTS pregnancies eligible for laser surgery up to 26 weeks’ gestation.|
|- Exclusion criteria||1. Triplet pregnancies |
2. Language problems for informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mrt-2008|
|- planned closingdate||15-mrt-2010|
|- Target number of participants||184|
|- Interventions||‘Solomon technique’: after identification and coagulation of each individual anastomosis, the complete vascular equator is coagulated from one placental margin to the other. Compared to the ‘Selective technique’: The vascular anastomoses are first identified and subsequently coagulated one by one.|
|- Primary outcome||Primary outcome measure will be the prevalence of TAPS or recurrence of TTTS. |
|- Secondary outcome||Secondary outcomes include residual anastomoses on placental injection, perinatal mortality and neonatal morbidity.|
|- Timepoints||Follow-up of TTTS survivors will be 2 year.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. F. Slaghekke|
|- CONTACT for SCIENTIFIC QUERIES||Dr. F. Slaghekke|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC), Department of Obstetrics and Fetal Medicine|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||As shown in a recent randomized trial, the best available treatment for twin-to-twin transfusion syndrome (TTTS) to date is fetoscopic laser surgery. The aim of fetoscopic laser treatment is to interrupt the inter-twin circulation through coagulation of the vascular anastomoses on the placental surface.
Several studies have shown that laser treatment for TTTS is not always effective and failure can lead to severe complications. Up to 33% of placentas treated with laser may still have residual anastomoses. These residual anastomoses can lead to several hematologic complications, including the twin anemia-polycythemia sequence (TAPS).
A possible solution to the problem would be to adopt an alternative laser surgery technique, in which not only the anastomoses but the entire vascular equator is coagulated. The main goal of this technique is to reduce the incidence of small, residual anastomoses.
The aim of this multicenter randomized controlled trial is to compare the new laser-technique in which both placenta shares are separated by coagulation of the entire vascular equator (hence the term "Solomon") to the currently most often used selective laser technique where only the visible vascular anastomoses are coagulated. |
|- Main changes (audit trail)||4-7-2013:|
An adjustment to the primary outcome and sample size calculation was made after the start of recruitment and was approved by the medical ethics committee (P07.261). The initial primary outcome was reduction of TAPS and recurrent TTTS and sample size was based on a reduction of 15% (20% in the Solomon group versus 5% in the Selective group). Secondary outcomes were perinatal mortality and neonatal morbidity.
Since it was of high importance to show that the use of the new treatment modality would not have a negative effect on perinatal mortality and neonatal morbidity, we therefore included perinatal mortality and severe neonatal morbidity in the primary outcome. The expected reduction of the composite outcome of 15%, with 45% in the Solomon group and 60% in the selective group, increased the sample size from 184 to 274 patients.
|- RECORD||4-mrt-2008 - 4-jul-2013|