APLASIA

Technical Field:

Medicine Gynecology Minimal Access Surgery

Background Art :-

Vaginal agenesis is a rare anomaly that carries serious pychologic, social and sexual impacts on the patient and her family as well (1,2). The main goal of treatment should focus in restoring normal sexual function of the neovagina. With the modern and advancing medical technology, there is a growing hope for fertility for those women (3-5). The ideal method of vaginal replacement should provide a cosmetically acceptable, low maintenance vaginal substitute with minimal morbidity and excellent long-term function. Currently there is no consensus among the various surgical subspecialties regarding the optimal method of vaginal replacement.(ό). Dilators are generally effective in creating a functionally useful vagina (Frank Method) (7). Vecchietti operation is a surgical modification of Frank's method and is subjected to some modifications (8) and can be easily performed laparoscopically (9, 10). Most of the novel advances in vaginal reconstruction have been related to the advances made in laparoscopic techniques (11). Nevertheless, Vecchietti operation is tedious and usually performed by well-trained specialized teams utilizing sophisticated instrumentation. This patent aims to assess safety, feasibility and efficacy of an alternative trans-vaginal traction (TVT) vaginoplasty procedure utilizing an olive attracted upwards towards the anterior abdominal wall via space of Reitzus. References:

1. Poland ML, Evans TN. Psychologic aspects of vaginal agenesis. J Reprod Med. 1985;30(4):340-4.

2. Morgan EM, Quint EH. Assessment of sexual functioning, mental health, and life goals in women with vaginal agenesis. Arch Sex Behav. 2006;35(5):607-18.

3. Prapas, Y., Papanicolaou, A., Prapas, N., Goutzioulis, M., Papanicolaou, N. Term pregnancy after vaginal transplantation in a case of vaginal agenesis with a functional uterus. Acta Europaea fertilitatis 1993;24 (2), 77-78.

4. PanieL B. J., Haddad, B. Utero-vaginal aplasia and pregnancy. Journal de Gynecologie Obstetrique et Biologie de Ia Reproduction 1994; 23 (5), 626-628.

5- Moura, M.D, Navarro, P.A.A.S, Nogueira, A.A. Pregnancy and term delivery after neovaginoplasty in a patient with vaginal agenesis . International Journal of Gynecology and Obstetrics 2000; 71 (3),215- 6. ACOG Committee on Adolescent Health Care: ACOG Committee Opinion, Number 274, July 2002.

7. . Mizia K, Bennett MJ, Dudley J, Morrisey J. Mϋllerian dysgenesis: a review of recent outcomes at Royal Hospital for Women. Aust N Z J Obstet Gynaecol. 2006;46(l):29-31

8. Folgueira G, Perez-Medina T, Martinez-Cortes L, Martinez-Lara A, Gomez B, Izquierdo J, Bajo-Arenas J. Laparoscopic creation of a neovagina in Mayer- Rokitansky-Kuster-Hauser syndrome by modified Vecchietti's procedure. Eur J Obstet Gynecol Reprod Biol. 2006; 127(2):240-3

9. Fedele L, Bianchi S, Berlanda N, Fontana E, Bulfoni A, Borruto F.. Laparoscopic creation of a neovagina with the laparoscopic Vecchietti operation: comparison of two instrument sets. Fertil Steril. 2006 ;86(2):429-32. lO.Brucker SY, Gegusch M, Zubke W, Rail K, Gauwerky JF,

Wallwiener D. Neovagina creation in vaginal agenesis: development of a new laparoscopic Vecchietti-based procedure and optimized instruments in a prospective comparative interventional study in 101 patients. Fertil Steril. 2008;90(5): 1940-52. l l .Davies MC, Creighton SM. Vaginoplasty. Curr Opin Urol.

2007;17(6):415-8. Disclosure of Invention:

Under general anesthesia, the bladder is evacuated followed by insertion of a rigid catheter guide (bladder stylet) loaded inside a urethral catheter. It aims to mobilize the bladder neck away from the tip of the needle when it passes into the retropubic space. A 7 mm suprapubic incision is made 2 cm on both sides of the midline in the suprapubic area 2 cm above the symphysis pubis in the same manner as tension-free vaginal tape (TVT) operation for treating genuine stress incontinence. A specially designed sharp curved needle with a wide fensterum attached to a plastic handle is used to perforate the vaginal dimple bilaterally just 1 cm below the bladder neck. A 1 cm width and 30 cm length strip of mesh is stretched then loaded into the fenestrum of the needle (Figure 1). A fenestrated oval 2x3 cm plastic olive is loaded on the tape. The needle is inserted through the vaginal dimple skin without prior incision directed upwards and slightly lateral towards the space of Reitzus with simultaneous mobilization of the bladder inwards and laterally to the ipsilateral side with the bladder stylet. Thereafter, the needle is directed slightly medial towards the suprapubic incision of the ipsilateral side. Once the tape is seen, the needle is withdrawn while the tape is clamped by a forceps. The bladder catheter is then removed followed by cystoscopic examination. If the bladder is intact, the same steps were repeated on the other side. Traction on the tape is maintained by applying an umbilical cord plastic clamp on each arm. To avoid skin ischemia, an intervening layer of sterile gauze is placed underneath a stainless steel fenestrated plate. To avoid retention effect of the olive, a urethral catheter is inserted and fixed. After a short postoperative interval, before discharge, the patient is instructed to maintain antibiotic coverage and to take a non-steroidal antiinflammatory drug whenever required. She is taught how to evacuate and care for the urine collection bag, make frequent proper vaginal douches using bovidone iodine 10%, and apply sterile vulvar dressings to guard against ascending infection. Brief Description of Drawing :

A specially designed sharp curved needle with a wide fensterum attached to a plastic handle is used to perforate the vaginal dimple bilaterally just 1 cm below the bladder neck to allow a tape for traction. A fenestrated oval plastic olive is loaded on the tape. The needle may be sealed with the tape.