R Tros1, M A van Kessel2, S M J van Kuijk3, G J E Oosterhuis4, W K H Kuchenbecker5, J Kwee6, M Y Bongers7, B W J Mol8, C A M Koks9. 1. Department of Obstetrics and Gynaecology, Amsterdam UMC, VU Universiteit Amsterdam, De Boelelaan 1117 Amsterdam, the Netherlands. Electronic address: r.tros@vumc.nl. 2. Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, 7500 KA, the Netherlands. Electronic address: m.vankessel@mst.nl. 3. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands. Electronic address: sander.van.kuijk@mumc.nl. 4. Department of Obstetrics and Gynaecology, St. Antonius Hospital, 3543 AZ Utrecht, the Netherlands. Electronic address: j.oosterhuis@antoniusziekenhuis.nl. 5. Department of Obstetrics and Gynaecology, Isala, 8000 GK Zwolle, the Netherlands. Electronic address: w.k.h.kuchenbecker@isala.nl. 6. Department of Obstetrics and Gynecology, OLVG West, 1061 AE Amsterdam, the Netherlands. Electronic address: j.kwee@olvg.nl. 7. GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Department of Obstetrics and Gynaecology, Maxima Medical Center, 5500 MB Veldhoven, the Netherlands. Electronic address: m.bongers@mmc.nl. 8. Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, 246 Clayton Road Clayton, Victoria 3168 Australia. Electronic address: b.w.mol@amc.uva.nl. 9. Department of Obstetrics and Gynecology, Maxima Medical Center, 5500 MB Veldhoven, the Netherlands. Electronic address: c.koks@mmc.nl.
Abstract
OBJECTIVE: To assess the capacity of transvaginal hydrolaparoscopy (THL) versus hysterosalpingography (HSG) as a primary tool to diagnose tubal pathology. STUDY DESIGN: We performed a multicenter RCT (NTR3462) in 4 teaching hospitals in the Netherlands, comparing THL and HSG as first line tubal test in subfertile women. The primary outcome of the trial was cumulative live birth rate at 24 months. Here, we present the secondary outcomes, the diagnostic findings of both THL and HSG as well as performance defined as failures, complications and pain- and acceptability scores. RESULTS: Between May 2013 and October 2016, we allocated 149 women to THL and 151 to HSG, of which 17 women in the THL group (11.4%) and 12 in the HSG group (7.9%) conceived naturally before the scheduled procedure, while 13 HSGs and 5 THLs were not performed for other reasons (withdrawal of informed consent, not willing to undergo tubal testing and protocol violations). A total of 119 THLs and 134 HSGs were carried out. Failures were seen more in the THL group (n = 8, 5.6%) than in the HSG group (n = 1, 0.7%) (p = 0.014). Complications did not differ significantly between the groups (THLn = 4; 2.8% vs HSGn = 1; 0.7%) (p = 0.20). Bilateral tubal occlusion was detected in one versus three women (0.9% versus 2.2%) of the THL group and HSG group, while unilateral tubal occlusion was detected in seven (6.2%) versus eight (5.9%) women, respectively. Normal findings were seen in 96 (79.3%) women randomised to THL and in 119 (87.5%) in women randomised for HSG (RR 0.91 95%CI 0.81-1.01, p = 0.08). The pain score was significantly less for THL (VAS 4.7 (SD: 2.5)) than for HSG (VAS 5.4 (SD:2.5)) (p 0.038). The acceptability rate of THL and was high and comparable. CONCLUSION:THL and HSG have a comparable capacity in diagnosing tubal pathology with comparable performance in safety, pain and acceptability.
RCT Entities:
OBJECTIVE: To assess the capacity of transvaginal hydrolaparoscopy (THL) versus hysterosalpingography (HSG) as a primary tool to diagnose tubal pathology. STUDY DESIGN: We performed a multicenter RCT (NTR3462) in 4 teaching hospitals in the Netherlands, comparing THL and HSG as first line tubal test in subfertile women. The primary outcome of the trial was cumulative live birth rate at 24 months. Here, we present the secondary outcomes, the diagnostic findings of both THL and HSG as well as performance defined as failures, complications and pain- and acceptability scores. RESULTS: Between May 2013 and October 2016, we allocated 149 women to THL and 151 to HSG, of which 17 women in the THL group (11.4%) and 12 in the HSG group (7.9%) conceived naturally before the scheduled procedure, while 13 HSGs and 5 THLs were not performed for other reasons (withdrawal of informed consent, not willing to undergo tubal testing and protocol violations). A total of 119 THLs and 134 HSGs were carried out. Failures were seen more in the THL group (n = 8, 5.6%) than in the HSG group (n = 1, 0.7%) (p = 0.014). Complications did not differ significantly between the groups (THL n = 4; 2.8% vs HSG n = 1; 0.7%) (p = 0.20). Bilateral tubal occlusion was detected in one versus three women (0.9% versus 2.2%) of the THL group and HSG group, while unilateral tubal occlusion was detected in seven (6.2%) versus eight (5.9%) women, respectively. Normal findings were seen in 96 (79.3%) women randomised to THL and in 119 (87.5%) in women randomised for HSG (RR 0.91 95%CI 0.81-1.01, p = 0.08). The pain score was significantly less for THL (VAS 4.7 (SD: 2.5)) than for HSG (VAS 5.4 (SD:2.5)) (p 0.038). The acceptability rate of THL and was high and comparable. CONCLUSION:THL and HSG have a comparable capacity in diagnosing tubal pathology with comparable performance in safety, pain and acceptability.