Improvement in mechanics, traction device, and instruments
We could develop a complete application set by improving the traction device and the applicators and by integrating a dilator for the rectum and different dummies for the postoperative use. But the most important thing is the completely new developed traction device with new mechanics and the integration of necessary regulation systems.
Traction device
Thanks to the rounded edges and the flat, solid surface, the traction device (Fig. 1) sits well on the patient’s skin without causing any significant pressure points. The extremely tolerable, biocompatible material is a plus for the patient’s comfort.
To attach the threads to the traction device, the threads are passed along the sides of the traction device over movable rollers (to protect the thread) [1] to the spring opposite [2]. The springs also have movable rollers [3] to protect the thread. The threads are run around these and then placed in the holding device slit. After lowering the tensioning wheel [4] until a click is heard, the tension can be built up in intervals by turning the wheel. The great advantage of this is that both threads can be tightened simultaneously, and most important, evenly. Furthermore, the tensile direction is predetermined throughout the entire procedure. Partial relaxation of tension is possible at any time via the release lever [5]. Once the desired tension has been attained the tensioning wheel should be locked into position via the safety lever [6]. This safety device prevents the patient or operator from releasing the traction device unintentionally. To increase and decrease tension the safety lever must be released.
For cleaning and sterilization purposes the traction device can easily be dismantled into five parts and prepared by undoing the screws [7]. The entire instrument set can be autoclaved.
Applicators
The following applicators are part of the neovagina set:
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1.
Thread guide straight for the vagino-abdominal perforation after Wallwiener
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2.
Two curved thread guides, one large and one small, both with two different bends for the abdomino-vaginal perforation after Fedele or peritonealization, respectively (Fig. 2a)
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3.
Pluggable segmented dummy (Fig. 2c)
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4.
Dummies: small preoperative dummy and postoperative dummies in different sizes for individual configurations (Fig. 2d)
All the thread guides are equipped with ergonomic handles (Fig. 2a).
The curvature of the thread guide has been optimized to enable the surgeon to apply different surgical variants [3, 4, 7]. This modified curvature now also facilitates the positioning of the traction device as cranially as possible while allowing the execution of a complete peritonealization.
Positioning the device as far toward cranial as possible enables a precisely cranioventral tensile direction, thus ensuring greatest dilation potential of the neovagina as regards maximizing length (Fig. 3).
This correct position prevents an excessively ventral tension direction which tends to result in, as described in the literature [7], too short neovaginas or even bladder lesions due to luxation of the pluggable segmented dummy intraabdominally.
The distal tips of the thread guides have been improved (Fig. 2b). They are sharp-edged for ensuring a smooth perforation of the septum recto-vaginale respectively to ease the retroperitoneal positioning of the traction threads. The bore holes are perfectly adjusted to the recommended threads (Terylene USP 4, Serag Wiessner).
We had good clinical results with the intraoperatively used pluggable segmented dummy (Fig. 2c). It was adapted to the postoperatively used dummy. This pluggable segmented dummy now has only one hole which is a hygienic advantage. Like the dummies for dilation it is made of a good tolerated material and can be autoclaved.
Among the different dummies there is a preoperative dummy. The patients can use it to dilate the pseudohymen preoperatively or to practice how to use the postoperative dummy. It is important to know that in some cases not the pseudohymen is dilated but the urethra. But in these cases one cannot find a remaining incontinence, an irritation of the mucous membrane, or an increasing number of cystitis.
Finally, the set contains individually formed dummies in different sizes in order to suit the varying sizes and individual configurations of neovaginas.
At the moment there are dummies (Fig. 2d) in six different sizes available (length 10 or 12 cm; 2, 2.5, and 3 cm in diameter). They have a loop where one can fasten a thread. Because of hygienic causes the surface is completely smooth. Every set contains a little brush for cleaning the loop. So, because of the material and the surface an optimal functionality and hygiene is achieved.
The rectum dilator, also recommended for use with the set (Clermont-Ferrand model, Karl-Storz, Germany), serves to distance the rectum from the rectovaginal septum, base of the bladder, and path of the ureters, if digital distancing is insufficient.
Clinical application
Operative technique
The operative principle is based on stretching of the vaginal membrane intraabdominally. Via a pluggable segmented dummy, which is connected to two threads, pressure is continuously exerted on the vaginal membrane resulting in the formation by stretching of a neovagina within a matter of days. Using the vagino-abdominal perforation method of Wallwiener the two threads are drawn intraabdominally from the vaginal membrane using the straight single-prong thread guide, by means of which the vaginal membrane is perforated (through a single perforation), and then pulled outside the abdominal wall with a large curved thread guide which is positioned retroperitoneally from cranial to caudal. Using the abdomino-vaginale perforation method of Fedele one of the curved thread guides is used. This thread guide is also positioned retroperitoneally from cranial to caudal, then the vaginal membrane is perforated with this thread guide and the threads executing traction are threaded extraabdominal/extravaginal and then also pulled outside the abdominal wall. Outside the abdomen the threads are held taut by a traction device and tightened daily so that a constant stretching pressure is exerted on the vaginal membrane.
The vesicorectal tunnel does not have to be dissected.
Alongside optimal imaging, intralaparoscopic simultaneous cystoscopy for the purpose of diaphanoscopic–laparoscopic visualization of the exact localization of the bladder site before the vaginal perforation of the rectovaginal septum is just as essential as ruling out, by means of cystoscopy, a bladder and ureter lesion, or the intraoperative introduction of suprapubic urinary drainage. For this, the ideal positioning of the operation team is important (Fig. 4a).
Suprapubic urinary drainage guarantees undisturbed miction despite intensive tensioning of the threads and makes postoperative introduction of a transurethral catheter during the tensioning phase unnecessary, as this could cause necrosis due to the urethra wall becoming trapped between transurethral catheter and pluggable segmented dummy.
Postoperative application
The postoperative dummy is inserted into the vagina immediately after removing the traction device and pluggable segmented dummy (Fig. 5c,d).
It must be worn for several months post-surgery in conjunction with plenty of estrogen-containing cream, full-time in the first 3–4 weeks after the operation, then at least at night. Should regular intercourse not be possible after the healing/epithelialization phase, it must be worn at least at night for several additional months, since without intercourse there remains at least the theoretical risk of secondary shrinkage of the neovagina [14].
Experience has shown that initial coitus can take place with the understanding compliance of the partner as soon as 3 weeks after the operation. The dummies can be cleaned with conventional soap or disinfecting solution.
Clinical results
Through the perfected mechanics of the traction device the operative principle of formatting a neovagina by performing a continuous pressure on the vaginal membrane with a penis-formed dummy could be maintained. Because of all these improvements, it was possible to shorten the time of tension (3–4 days), still having the same functional and anatomical results (two fingers in diameter and a length about 10 cm; Table 1).
The new mechanics of the traction device, including the new feather and thread mechanism, led to a significant reduction of the time of tension. Also many complications that were caused by the old mechanics could be avoided. There was no case with a wrong placement and a wrong direction of the tension and at least no damage or tearing off of the threads.
The special surface of the traction device does not need a cushion and does not hurt the abdominal wall.