Abstract
Abstract
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.
Introduction
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Patients and Methods
Approval was obtained from the Internal Review Board (IRB number 09 07-133) prior to enrolling patients in this study. Patients with a nonpalpable testicle were identified at the time of surgical consultation and were subsequently enrolled only after obtaining consent from the patient's legal guardian. The consent forms and consent process were carefully evaluated by the Internal Review Board on a continuing basis.
Participants
The study population consisted children between the ages of 6 months and 10 years who were scheduled to undergo laparoscopic orchiopexy for a nonpalpable testis.
Interventions
All operations were performed by one of the five institutional staff surgeons, and the operative approach was controlled by the randomization sequence described below.
Determination of testicular position and mobility
All patients underwent a laparoscopic evaluation of testicular position and mobility by placement of a 5-mm port placed into the abdomen through a vertically oriented transumbilical incision. The intraabdominal testis was identified. If no testis was identified and a “blind ending” vas deferens was seen, no further intervention was performed. If no testis was identified but the vas deferens was seen exiting the internal ring, the abdomen was closed, and a groin exploration was performed to locate the testis or testicular remnant. A standard inguinal orchiopexy was performed if a viable testis was found at the time of inguinal exploration.
If an intraabdominal testis was encountered, an operating instrument was placed through the contralateral abdominal wall under direct vision, and the testis was grasped and brought to the contralateral internal ring to determine if the testicle was high or low, as has been previously described as a method to decide if a Fowler–Stevens orchiopexy would be necessary.1,6 If the testis reached to the contralateral internal ring, a standard laparoscopic orchiopexy was performed without division of the testicular vessels. If the testis did not reach the contralateral internal ring, the patient was enrolled into the study according to the next randomization sequence.
Patients randomized to the one-stage approach had an additional operating instrument placed for dissection of the peritoneum, the testis, and testicular vessels. The peritoneum was dissected from the retroperitoneum lateral to the intraabdominal testis and internal ring in the standard fashion to preserve the peritoneal and vasal blood supply to the testis. The testicular vessels were then divided, and adequate peritoneal dissection was carried out to allow for mobilization of the testis sufficiently to perform the orchiopexy. After mobilization, an incision was made in the median raphe of the scrotum, and a Dartos pouch was created. A 12-mm laparoscopic cannula was then placed through the pouch, above the symphysis pubis and into the peritoneal cavity medial to the inferior epigastric artery. The testis was then grasped and brought into the cannula. The cannula was removed while providing continuous traction on the testis, thus bringing the testis through the subcutaneous tract and through the scrotal incision. The position of the vas deferens was confirmed laparoscopically to ensure that there was no torsion. The testis was then secured to the Dartos fascia and the pouch, and the scrotal skin was closed. The umbilical cannula and instruments were removed, and the incisions were closed in the standard fashion.
Patients randomized to the two-stage arm had the testicular vessels divided at the initial operation via the instrument placed to confirm testicular mobility. The umbilical cannula and instrument were removed, and the incisions were closed in the standard fashion. The second stage was performed approximately 6 months later using the same technique described above for the single-stage approach.
Sample size and outcome variable
This was a pilot trial design with a sample size of 30 chosen in order to acquire adequate data for statistical design of a formal randomized controlled trial. The primary outcome variable was testicular survival at 6 months as documented by scrotal ultrasound.
Assignment
An individual unit of randomization was used in a nonstratified sequence in blocks of 4. After consent for study enrollment was obtained, the randomization sequence was accessed to identify the next allotment. The operation was then discussed with the family, as the allocated procedure could not be blinded to guardians or caregivers. As noted above, the family was counseled regarding the process of intraoperative decision making for randomization.
Data collection
Patient demographics and presenting testicular ultrasound position and characteristics were collected. Operative time, laterality, testicular location, and intraoperative complication were recorded. Postoperatively, the recovery course, outcomes, and charges were recorded. Any abnormal findings during the postoperative or follow-up visits were recorded.
Statistical analysis
Continuous variables were compared using an independent-sample, two-tailed Student's t test. Discrete variables were analyzed with the chi-squared test. Significance was defined as a P value of ≤.05.
Results
From October 2007 and September 2013, 112 patients were enrolled in the study. Of these, 29 patients met the criteria of inability to retract the testis to the contralateral inguinal ring and underwent appropriate randomization. Two of the 29 did not return for their second operation due to geographic relocation, leaving 27 patients (14 primary and 13 two-stage) included in the study population. All procedures were performed in the outpatient setting, with all patients being discharged the day of surgery.
Patient characteristics at operation did not differ between the two groups and are shown in Table 1. There was no difference in age, weight, or laterality between the two groups.
The total mean operative time was longer with the two-stage approach.
Patients in the two-stage group had higher total operative and total hospital charges. Regarding testicular survival, a single patient in each group suffered testicular atrophy, resulting in a testicular survival rate of 93% and 92% for the primary and two-stage approaches, respectively (Table 2). There were no complications in either group.
Significant difference.
Discussion
An undescended testis is encountered in approximately 1%–2% of male infants. 7 The location of the undescended testis is variable, but about 20% are defined as nonpalpable. When a nonpalpable testis is encountered, the diagnostic evaluation is centered on determining if testicular tissue exists and, if present, locating it and determining if it can be brought into the scrotum. 8 If the testis is identified in the abdomen and is unable to be brought into the scrotum due to insufficient testicular vessel length, division of the vessels has been shown to allow for successful orchiopexy. The laparoscopic approach has been shown to be superior when compared with the open technique for a two-staged Fowler–Stevens orchiopexy.
With ongoing attention of cost-effective delivery of care while emphasizing the highest quality of care, it is not surprising that the laparoscopic single-stage Fowler–Stevens orchiopexy would be considered. This is even more obvious when the historical aspects of the Fowler–Stevens orchiopexy are investigated. In actuality, the initial description of the Fowler–Stevens orchiopexy was that of a single stage, where the vessels were divided and the testicle was relocated to the scrotum at the same operation. 4 This technique was modified in 1987 by Oesch and Ransley. 5 Since that time, it has been the standard approach to perform the operation in a two-stage manner, with the expectation that there would be neovascularization of the testis from the surrounding peritoneum. A review in 2010 suggested that the two-stage approach may have superior testicular survival rates (approximately 85% compared with 80%); however, the authors clearly state that the level of evidence of the study was low. 9 In a separate single-institution retrospective study the single-stage laparoscopic orchiopexy has been shown to be as effective to the two-stage approach with regard to testicular atrophy rates. 10 An editorial comment from the systematic review noted above states, “Still, careful analyses of aggregated individual and team clinical experiences are the best pathway we have today. So which orchiopexy is better? Can there be an answer or a single ultimate truth? It is still a work in progress.” 9 With this in mind, the current study was designed.
As expected, there was no difference between the two study groups with regard to the demographics shown in Table 1. Also, as we would have expected, the overall operative time and total charges were significantly longer and higher in the two-stage approach. The difference in the actual operative minutes and charges nearly mirrored each other, with the two-stage charges being 1.75 times and operative time 1.65 times as much as the primary. This suggests that the difference in charges is directly related to the cost of the operation and not to other factors, such as equipment or complications. Although there were no complications in either group, it cannot be ignored that, although not factored into the operative or charge data, the two-stage procedure has the obligatory need for an additional general anesthetic, which does carry an increased risk, however small that may be.
The purpose of this study was to aid in the decision of whether a randomized controlled trial was warranted and to help delineate the sample size based on the most important outcome variable, testicular survival. The survival rates for the two approaches in this study are essentially identical (92% for two-stage and 93% for primary) and far superior to the review noted above. 9 This highlights an important aspect of prospective trials compared with retrospective data. However critically a researcher reviews a chart in a retrospective manner, inevitably the data will have inaccuracies that cannot be accounted for. Designing a superiority trial would require a very large number of patients to be enrolled and may be putting the patients randomized into the two-stage group at unnecessary risk related to multiple operations/anesthetics. Also, as we have shown, the financial burden related to the two-stage repair is significant. Perhaps the better approach to proving the effectiveness of the primary approach would be to perform a prospective observational study across multiple institutions to confirm the testicular survival rates we have shown. We are presently attempting to engage institutions to identify interest in such a study.
There are some limitations that deserve to be recognized. First, the study extended over a prolonged period of time. This was surprising to the authors, as prior to performing this study we did not recognize the actual infrequent need for testicular development. The prolonged enrollment period could be concerning if there were changes in the surgical complementation during that time. In actuality, there were absolutely no changes among the surgeons who participated in the study, and all five surgeons performed both primary and two-stage procedures throughout the study period.
The second criticism could include surgical technique. If surgeons performed different specific techniques during the procedures, there may be a bias toward techniques that had superior testicular survival rates. In general, all surgeons agreed to the surgical techniques that would be used within the procedures prior to beginning the study. Further supporting that differences in surgical technique could have biased one approach over the other is the fact that there was only a single testicle lost in each group, although all surgeons performed both the primary and two-stage approaches throughout the study, as noted above.
Finally, there may be concern about the follow-up period. Although 6 months may seem short over the course of a child's lifetime, we would point out that all patients underwent scrotal Doppler ultrasound to evaluate the testis that had undergone orchiopexy. Testicular survival required not only adequate testicular size, but evidence of normal blood flow through the relocated testis when compared with the contralateral normal testis. Even if a testis that had undergone Fowler–Stevens orchiopexy survived but then became atrophic after the 6-month ultrasound, it is hard to postulate why that testis, which had adequate blood flow at 6 months postorchiopexy, would subsequently lose that blood supply, and then attribute that event to the timing of testicular vessel division (i.e., primary versus two-stage).
In summary, this is the first study that has prospectively randomized children who require Fowler–Stevens orchiopexy into a primary or two-stage approach. This pilot study has shown that the primary approach to Fowler–Stevens orchiopexy for intraabdominal testes appears to have similar testicular survival rates as the two-stage approach. Surgeons may consider approaching these patients via a laparoscopic primary Fowler–Stevens technique, and a prospective observational study could be used to confirm these data.
Footnotes
Disclosure Statement
No competing financial interests exist.