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Journal Article
Randomized Controlled Trial
Laparoscopic Orchiopexy Requiring Vascular Division: A Randomized Study Comparing the Primary and Two-Stage Approaches.
BACKGROUND: Intraabdominal testes that lack sufficient vessel length to perform an orchiopexy require division of the testicular vessels. Historically, the vessels are divided at the initial operation, and the orchiopexy is then performed as a two-stage procedure with the assumption for the development of neovascularization along the vas deferens during the interim. Recent reports suggest the orchiopexy may be performed primarily at the time of vessel division. However, these strategies have not been prospectively compared. Therefore, we conducted a randomized pilot trial to examine the role for a larger comparative study.
PATIENTS AND METHODS: After Internal Review Board approval, all patients undergoing laparoscopic orchiopexy for a nonpalpable testis were considered for enrollment. This study was designed as a pilot study to evaluate testicular survival at 6 months of follow-up. After consent was obtained, computer randomization was used to determine a primary or two-stage orchiopexy. All procedures were performed by five surgeons, and allotment had no affect on surgeon selection.
RESULTS: Between October 2007 and September 2013, 112 patients were enrolled in the study. Twenty-seven patients (14 primary and 13 two-stage) met criteria for randomization based on inability to bring the testis to the contralateral internal ring. There was no difference in the approach among surgeons. Mean operative time and cost significantly favored the primary approach, and testicular survival rates were the same.
CONCLUSIONS: Based on the data in our pilot study, approximately 70% of patients with a nonpalpable testis will not require vascular division. This study suggests that when vascular division is required, the primary orchiopexy may be equivalent to the traditional two-stage procedure with regard to testicular survival and superior to the two stage in total operative time and charges. These data provide evidence for sufficient equipoise to proceed with the development of a large multi-institutional trial comparing these two approaches.
PATIENTS AND METHODS: After Internal Review Board approval, all patients undergoing laparoscopic orchiopexy for a nonpalpable testis were considered for enrollment. This study was designed as a pilot study to evaluate testicular survival at 6 months of follow-up. After consent was obtained, computer randomization was used to determine a primary or two-stage orchiopexy. All procedures were performed by five surgeons, and allotment had no affect on surgeon selection.
RESULTS: Between October 2007 and September 2013, 112 patients were enrolled in the study. Twenty-seven patients (14 primary and 13 two-stage) met criteria for randomization based on inability to bring the testis to the contralateral internal ring. There was no difference in the approach among surgeons. Mean operative time and cost significantly favored the primary approach, and testicular survival rates were the same.
CONCLUSIONS: Based on the data in our pilot study, approximately 70% of patients with a nonpalpable testis will not require vascular division. This study suggests that when vascular division is required, the primary orchiopexy may be equivalent to the traditional two-stage procedure with regard to testicular survival and superior to the two stage in total operative time and charges. These data provide evidence for sufficient equipoise to proceed with the development of a large multi-institutional trial comparing these two approaches.
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