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Comparison of Two Techniques of Laparoscopy-Assisted Peritoneal Vaginoplasty
Original Article
Comparison of Two Techniques of Laparoscopy-Assisted Peritoneal Vaginoplasty Jie Wu, MSc, Ruixia Guo, MD*, Danxia Chu, MSc, Xinyan Wang, MSc, Liuxia Li, MD, Aiping Bian, MSc, Qian Zhao, MSc, and Huirong Shi, MD From the Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zheng Zhou, China (all authors).
ABSTRACT Neovagina creation is essential for patients with the Mayer-Rokitansky-Kuster-Hauser syndrome. We compared a technique involved the pushing down of the peritoneum with the technique of separating the peritoneum for laparoscopy-assisted peritoneal vaginoplasty. We collected patients with congenital absence of vagina who underwent laparoscopy-assisted peritoneal vaginoplasty of the First Affiliated Hospital of Zhengzhou University between January 2011 and May 2013. The 2 surgical groups (pushing group and separating group) were compared for various parameters. The values of the following parameters were significantly lower for the pushing group compared with the separating group: mean operating time (78 6 13 minutes vs 135 6 28 minutes), mean duration of hospitalization (12.9 6 2.7 days vs 18.0 6 3.8 days), mean cost of hospitalization (14 016 6 1640 RMB vs 18 783 6 2143 RMB), requirement for a drainage tube (4% vs 27%; c2 5 8.864), requirement for analgesic drugs (20% vs 40%; c2 5 3.977), and postoperative rehospitalization (3.3% vs 10.0% at 2 months and 6.7% vs 26.7% at 6 months; c2 5 4.268 and 5.196). Mean values for blood loss (57 6 19 mL vs 66 6 20 mL), time to pass gas (21 6 4 hours vs 23 6 7 hours), and length of the reconstructed vagina (9.0 6 0.4 cm vs 8.9 6 0.5 cm) were not significantly different between the 2 groups. In addition, mean postoperative Female Sexual Function Index score did not differ significantly between the 2 groups or among the 2 groups and a control group (27.0 6 4.8 vs 26.7 6 5.2 vs 27.9 6 4.5; p . .05). The technique involving pushing down of the peritoneum offers advantages of reduced cost, complications, hospitalization, operative time, and pain over the traditional technique. Sexuality approaches so-called ‘‘normal’’ sexuality. Journal of Minimally Invasive Gynecology (2016) 23, 346–351 Ó 2016 AAGL. All rights reserved. Keywords:
Laparoscopic vaginoplasty; Peritoneum; Surgery; Vaginal agenesis
Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome is characterized by congenital aplasia of the uterus and of the superior two-thirds of the upper vagina [1]. Clinically, MRKH syndrome can occur as an isolated syndrome (type I) or in combination with malformations in other organ systems (type II) [2]. Almost all patients with MRKH syndrome have normal secondary sex characteristics, a female karyotype of 46 XX, normal vulvar appearance, an absent vagina, and primary amenorrhea [3]. The condition is rare, with an incidence of 1:4500 in America [4] and 1.9% within the Chinese [5]. The authors declare no conflicts of interest. Corresponding author: Ruixia Guo, MD, Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, No. 1 East Construction Rd, Zhengzhou 450052, People’s Republic of China. E-mail: [email protected] Submitted September 12, 2015. Accepted for publication October 26, 2015. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2016 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.10.015
Surgery is recommended for vaginal reconstruction. The surgical techniques are designed to create a canal of adequate size oriented in the correct axis by developing the space between the bladder and rectum. Pratt [6] reported the use of sigmoid colon in vaginal reconstruction in 1961. Subsequently, harvesting free skin [7] and skin flaps [8] to form the lining of the neovagina were reported. Davydov [9] in 1969 and Rothman [10] in 1972 proposed a method for reconstructing the new vaginal lining with the peritoneum from the Douglas pouch. This traditional technique using the patient’s own peritoneum involves dissection to free the peritoneum and then pulling it down to the mucosa of the introitus. Laparoscopically assisted colpopoiesis from the pelvic peritoneum without pelvic dissection was introduced by Popp in 1992 [11], and is well presented in international publications [12]. Soong et al [13] first described peritoneum vaginoplasty with the aid of a laparoscope. In 2008, Luo [14] proposed improving this procedure with the use a
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laparoscope along with a special peritoneal propeller, in what became known as the Luohu technique. Today, many surgeons are moving away from the traditional Davydov technique and making modifications of their own; however, few studies to date have compared the improved technique with the traditional technique through specific data evaluation. Our technique can be considered a modified version of the Luohu technique. We use a routine instrument, the clamp holding a gauze roll, to push down the peritoneum from the pelvic cavity to the introitus under laparoscopic guidance. In the present study, we sought to evaluate the safety and efficacy of this technique by comparing it with the traditional technique in terms of various parameters.
Assessment of Surgical Technique
Materials and Methods
Surgical Procedure
The same competent physician was responsible for the evaluation of perioperative parameters, such as blood loss, hospitalization costs, and patient recovery. Intraoperative blood loss was assessed by measuring the blood drawn by a suction device and weighing the blood-soaked gauze. Functional outcome was assessed using the FSFI, a brief and validated self-reporting questionnaire evaluating female sexual function. The FSFI encompasses 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Functional outcome was deemed very good at an FSFI score of R30, good at an FSFI score of 23 to 29, and poor at an FSFI score ,23. The FSFI scores for the 2 study groups were compared with those of the control group.
Study Design and Patients This study was designed as a retrospective investigation of the clinical characteristics of 60 patients with congenital absence of vagina who underwent laparoscopyassisted peritoneal vaginoplasty at the Obstetrics and Gynecology Department of the First Affiliated Hospital of Zhengzhou University between January 2011 and May 2013. The patients underwent vaginoplasty using the technique of pushing down the peritoneum or the technique of separating the peritoneum and were classified into 2 groups, the pushing group (n 5 30) and the separating group (n 5 30) accordingly. The choice of technique was made on a case-by-case basis, depending on the preference of attending surgeon. The same groups of doctors (a chief physician, an associate chief physician or attending physician, and 1 or 2 assistants) performed all of the procedures. In addition, data were acquired from 30 normal, age-matched women for comparison of Female Sexual Function Index (FSFI) scores with the study groups. These women were all family members of outpatients, and had no gynecologic disorders during the followup period. The study was approved by the Internal Review Board of the First Affiliated Hospital of Zhengzhou University, and informed consent was obtained from each enrolled patient. The mean patient age was 20 years (range, 17–24 years) in the pushing group and 21 years (range, 20–25 years) in the separating group (p 5 .15). Three patients (10%) in the pushing group and 2 patients (6.7%) group and separating group were married (p 5 .964). All enrolled patients had a normal 46 XX karyotype on chromosomal analysis, normal sex hormone levels, normal vulvar development, absence of vagina, and primary amenorrhea. Abdominal sonography revealed the presence of normal bilateral ovaries but an absent or primordial uterus in all cases. None of the patients had a history of pelvic surgery or pelvic tuberculosis or chronic pelvic inflammatory disease likely to cause extensive adhesions in the peritoneal cavity.
Preoperative Preparation Two days before surgery, the patient was restricted to a semiliquid diet and given oral metronidazole. On the day before surgery, the patient underwent intestinal lavage. A vaginal mold was prepared in-house and sterilized at high temperature. The procedure was performed with the patient under general anesthesia and in the supine lithotomy position. Pushing Group The first laparoscopic step was to establish pneumoperitoneum and advance a laparoscope through a subumbilical incision to carefully inspect the entire abdominal and pelvic cavity. Next, at the perineum, the dimple of the vulva was identified and diluted adrenaline in saline was injected therein; an H-shaped incision was then made at the site,
Fig. 1 Laparoscopic image showing the gauze rolls held by endoscopic nippers.
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Fig. 2
Fig. 4
Laparoscopic view from a point on the bottom of the pelvic cavity and behind the vestige of the uterus. The image shows the point where the peritoneum was pushed down to the orifice of the new canal using the routinely available clamp and gauze.
Intraoperative image showing a plus-shaped incision made to open the peritoneum.
and sharp and blunt dissection was performed into the rectovesical space up to a depth of approximately 8 cm. In the second laparoscopic step, a point at the base of the pelvic cavity behind the uterine vestige was identified. A clamp holding a gauze roll was then applied at this point by continuous and gradually increasing force to push the peritoneum down to the orifice of the new canal until the end of the gauze, with the intact peritoneum, was visible from the introitus (Figs. 1–3). Additional blunt dissection with the fingers was then performed under the peritoneum to prevent the rectal walls and vesicular walls from folding in, which can cause injury during dissection and suturing. Next, a plus sign–shaped incision was made to open the pushed-down portion of the peritoneum. The gauze was then removed (Figs. 4 and 5), and 4 stitches were placed in each quadrant with 2/0 absorbable suture to affix the peritoFig. 3 Schematic illustration of Figure 2, sagittal view.
neum to the incised margin of the introitus. Then the vaginal mold was inserted and fixed, and interrupted sutures were placed on the surface membrane of the bladder and rectum under laparoscopic guidance and drawn tightly to close the base of the pelvic cavity and the vault of the neovagina (Fig. 6). Separating Group The first laparoscopic step and subsequent perineal step were the same as those described for the pushing group. Thereafter, the peritoneum was freed by blunt dissection in all directions using separating pliers under laparoscopic guidance; the freed peritoneum could then be easily pulled down to the vaginal mucosa [12]. The edges of the opened
Fig. 5 Intraoperative image showing removal of the gauze.
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Fig. 6
Table 1
Intraoperative laparoscopic image showing closure of the bottom of the pelvic cavity and the vault of the neovagina.
Operative data by group
Parameter
Separating Pushing group group (n 5 30) (n 5 30)
122 6 29 214 6 35 Operating time, min, x6s 57 6 19 66 6 20 Blood loss, mL, x6s Requirement for drainage tube, %* 4 27 Time to pass gas, h, x6s 21 6 4 23 6 7 Requirement for analgesics, %y 20 40 Postoperative hospital stay, d, x6s 12.9 6 2.7 18.0 6 3.8 Hospitalization costs, RMB, x6s 14 016 6 1640 18 783 6 2143 * According to the size of the wound and extent of leakage, the surgeons reached a consensus regarding the need for an intraoperative drainage tube. y Patients’ requests for oral pain medication or injections for intolerable postoperative pain were taken into account; no repetitive statistics.
pelvic peritoneum were sutured to the mucosa at the introitus, and an anastomosis was established between the peritoneum and vaginal vestibulum. Finally, the superior peritoneal leaf was closed by interrupted sutures placed under laparoscopic guidance.
rating group (mean, 78 6 13 minutes vs 135 6 28 minutes; p 5 .017 and 4% vs 27%; c2 5 8.864; p 5 .012). Further, mean intraoperative blood loss was lower in the pushing group compared with the separating group, but not significantly so (57 6 19 mL vs 66 6 20 mL; p 5 .067). The operative parameters in the 2 groups are compared in detail in Table 1.
Postoperative Care
Postoperative Evaluation
As a general rule, the vaginal mold was changed each day and then removed 7 to 10 days after the operation. After daily disinfection, replacement was done at the hospital until the patient or her caretaker learned how to properly place, change, and disinfect the vaginal mold, at which point the patient was discharged. Sexually inactive patients were instructed to keep the mold in place day and night for 3 months after the surgery, and then to continue placement at night for 4 to 6 months.
The mean time to passing gas was lower in the pushing group than in the separating group, but not significantly so (21 6 4 hours vs 23 6 7 hours; p 5 .081). The separating group had significantly greater use of analgesics (40% vs 20%; c2 5 3.977; p 5 .046), length of hospital stay (mean, 18.0 6 3.8 days vs 12.9 6 2.7 days; p 5 .023), and hospitalization costs (mean, 18 783 6 2143 RMB vs 14 016 6 1640 RMB; p 5 .012).
Statistical Analysis Data were analyzed using SPSS for Windows version 16.0 (SPSS, Chicago, IL). The Student t test and the c2 test were used for analysis of quantitative variance and categorical variance, respectively. Enumeration data analysis was performed using ratios. Significance for all statistical tests was set at p 5 .05. Results Intraoperative Parameters The surgery was uneventful in all but 2 cases; 1 patient in each group experienced rectal injury, which was immediately recognized and repaired with no further complications. The operating time and requirement for a drainage tube were significantly lower in the pushing group than in the sepa-
Functional Outcome The rates of postoperative rehospitalization at 2 months and 6 months were significantly higher in the separating group compared with the pushing group (10% vs 3.3%; c2 5 4.268; p 5 .039 and 26.7% vs 6.7%; c2 5 5.196; p 5 .023, respectively). At 2 months after surgery, 1 patient from the pushing group and 2 patients from the separating group revisited the hospital because of vaginal polyps, and 1 patient from the separating group did so because of vaginal infection. Complications necessitating rehospitalization at 6 months after surgery included vaginal polyps in 2 patients of the pushing group and 4 patients of the separating group, vaginal infection in 1 patient of the separating group, vaginal adhesions in 2 patients of the separating group, and vaginal hernia in 1 patient of the separating group. All patients were assessed for sexual function using the FSFI. All of them reported attempting to have sexual
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Table 2 Assessment of sexual function by the FSFI in women who underwent peritoneal vaginoplasty and an age-matched control group
FSFI measure
Pushing group Separating group Control group (n 5 30) (n 5 30) (n 5 30)
No sexual activity 0 Desire score 4.4 6 0.9 Arousal score 4.4 6 1.0 Lubrication score 4.6 6 1.3 Orgasm score 4.2 6 1.2 Satisfaction score 4.6 6 1.0 Pain score 4.8 6 1.4 Full FSFI score 27.0 6 4.8
0 4.3 6 0.8 4.5 6 1.1 4.7 6 1.2 4.1 6 1.1 4.5 6 1.2 4.6 6 1.3 26.7 6 5.2
0 4.4 6 0.8 4.6 6 0.8 4.9 6 0.9 4.4 6 1.2 4.5 6 1.1 5.1 6 1.1 27.9 6 4.5
FSFI 5 Female Sexual Function Index. There were no significant differences among the 3 groups.
intercourse. The average delay between surgery and the attempt was 5.0 months (range, 1–18 months) in the pushing group and 5.7 months (range, 2–19 months) in the separating group, with no significant difference between the 2 groups. Table 2 presents the FSFI scores for the 2 study groups and the control group. The mean total FSFI score was 27.0 6 4.8 for the pushing group, 26.7 6 5.2 for the separating group, and 27.9 6 4.5 for the control group, with no significant difference among the 3 groups (p . .05). Figures 1–3 show the distribution of FSFI domain scores in the 3 groups. At 3 months after surgery, the reconstructed vagina had a mean length of 9.0 6 0.4 cm in the pushing group and 8.9 6 0.5 cm in the separating group, showing no significant difference between the 2 groups (p 5 .072). Discussion In MRKH syndrome, congenital absence of the vagina is associated with physiological abnormalities and emotional distress. Various methods of vaginal reconstruction have been proposed, including grafting of skin flaps [7], colonic segments [6], and the amniotic membrane and peritoneum [15], each of which has benefits and drawbacks [16]. All these surgical techniques are designed to create a vaginal canal of adequate size with appropriate length, orientation, and secretory ability [17]. The peritoneum is believed to be the ideal tissue for reconstruction [18], because it executes the functions of absorption, secretion, and defense similar to the vaginal mucosa; has good healing ability; and has a smooth, soft, and moist surface, which allows for a satisfying sexual experience [19]. With extensive advances in the field of laparoscopic surgery, laparoscopy-assisted peritoneal vaginoplasty has yielded good results and reportedly offers the advantages of minimal injury and good aesthetic and functional outcomes [20]. Because laparoscopic surgery is performed within the airtight abdominal cavity, environmental influ-
ences are minimal; the abdominal cavity is relatively stable and subjected to much less surgical trauma than occurs in open abdominal surgery [21]. Soong et al [13] first described performing peritoneal vaginoplasty with the aid of a laparoscope. In this technique, herein termed the traditional technique, the peritoneum is extensively dissected from the bladder and rectum, making it nearly a free graft. In the more recently developed laparoscopic peritoneal vaginoplasty (Luohu) technique, a special peritoneal propeller is used to push the peritoneum down toward the orifice of the new canal by applying continuous, gradually increasing force [22]. Our technique can be considered a modified version of the Luohu technique, with the main difference being the use of a readily available clamp with a gauze roll to push down the peritoneal fold for vaginoplasty. This technique does not require any dissection beneath the peritoneum from the pelvic cavity wall, forming a small wound that produces less postoperative pain. Most of the blood supply to the peritoneum is preserved, facilitating survival of the mobilized peritoneum. The technique has the advantages of technical simplicity, no need for specialized instruments, and lower cost. It also has several advantages in terms of operative parameters. The operating time is shorter, which reduces the risk of intraoperative anesthesia; the need for placement of an intraoperative drainage tube is lower, which reduces the pain associated with postoperative extubation; postoperative analgesic requirement is low, allowing for good compliance; the rate of postoperative rehospitalization is lower, indicating a lower rate of complications; and the length of hospital stay is lower, which reduces treatment costs. In our cohort, surgery was uneventful in all but 2 cases. One patient in each group experienced rectal injury, which was immediately recognized and repaired, with no further complications and no obvious abnormalities on subsequent follow-up. Whether performed with peritoneal dissection or not,carries the following risks (i.e. bladder, rectum or other pelvic structures injuries). The formed vaginal opening was between the urethra and the anus, if urethral opening position is low, the distance between the urethra and anus was shortened, the formed vaginal position may be biased toward vestibular by anal side, easy to cause rectum to crack. Rectal injury is the most common injuries in vaginoplasty, incidence of about 4%-5% [23]. No matter which kind of damage found, should immediately be repaired. All patients who underwent surgery using our technique demonstrated good healing after surgery and reported satisfaction with the neovaginal depth. A 2.5-cm diameter vaginal mold could be easily inserted in all patients, confirming patency of the neovagina. All patients who attempted sexual intercourse reported almost normal sexual function, as per the FSFI scores, with no significant difference among the 2 surgical groups and the normal control group, indicate functional recovery to normal levels.
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Proper nursing care after laparoscopic peritoneal vaginoplasty is of the utmost importance. When the first mold is replaced, the patient may experience marked pain, because the incision is not completely healed at that time [24]. Nevertheless, postoperative vaginal dilation is essential to prevent vaginal stenosis. Given our study’s retrospective design, the possibility of selection bias exists. But in this study, the same group of surgeons performed all operations using both techniques, and a total of 60 cases were studied, supporting the validity of our results. Short-term results for laparoscopy-assisted vaginoplasty have been encouraging [25]; however, further studies are needed to assess the long-term functional outcome of our technique and test its feasibility for widespread clinical application, especially in regions where highly specialized equipment may be unavailable. In conclusion, the new technique that involves pushing down the peritoneum for laparoscopy-assisted vaginoplasty offers the advantages of reduced costs, complications, hospitalization, operative time, and pain over the traditional technique. Sexuality approaches so-called ‘‘normal’’ sexuality. This technique shows great promise for widespread application. Acknowledgment This work was supported by the Key Technologies Research and Development Program of the Health Development Planning Commission of Henan Province (201403069). Supplementary Data Supplementary data related to this article can be found online at http://dx.doi.org/10.1016/j.jmig.2015.10.015. References 1. Pizzo A, Lagana AS, Sturlese E, et al. Mayer-Rokitansky-KusterHauser syndrome: embryology, genetics and clinical and surgical treatment. ISRN Obstet Gynecol. 2013;2013:628717. 2. Fiaschetti V, Taglieri A, Gisone V, Coco I, Simonetti G. Mayer-Rokitansky-Kuster-Hauser syndrome diagnosed by magnetic resonance imaging: role of imaging to identify and evaluate the uncommon variation in development of the female genital tract. J Radiol Case Rep. 2012; 6:17–24. 3. Giannesi A, Marchiole P, Benchaib M, Chevret-Measson M, Mathevet P, Dargent D. Sexuality after laparoscopic Davydov in patients affected by congenital complete vaginal agenesis associated with uterine agenesis or hypoplasia. Hum Reprod. 2005;20: 2954–2957. 4. Morcel K, Camborieux L. Programme de Recherches sur les Aplasies M€ ulleriennes, Guerrier D. Mayer-Rokitansky-K€uster-Hauser (MRKH) syndrome. Orphanet J Rare Dis. 2007;2:13.
351 5. Gao ZM, Huang XH, Zhang JF, et al. Clinically characteristic analysis in 339 patients with congenital absence of vagina. J Pract Obstet Gynecol. 2007;23:562–564. 6. Pratt JH. Sigmoidovaginostomy: a new method of obtaining satisfactory vaginal depth. Am J Obstet Gynecol. 1961;81:535–545. 7. Lesavoy MA. Vaginal reconstruction. Urol Clin North Am. 1985;12: 369–379. 8. Wee JT, Joseph VT. A new technique of vaginal reconstruction using neurovascular pudendal-thigh flaps: a preliminary report. Plast Reconstr Surg. 1989;83:701–709. 9. Davydov SN. Colpopoiesis from the peritoneum of the uterorectal space. Akush Ginecol (Mosk). 1969;45:55–57 (in Russian). 10. Rothman D. The use of peritoneum in the construction of a vagina. Obstet Gynecol. 1972;40:835–838. 11. Popp LW, Ghirardini G. Creation of a neovagina by pelviscopy. J Laparoendosc Surg. 1992;2:165–173. 12. Davis G, Redwine D, et al. Laparoscopic management of vaginal aplasia with or without functional noncommunicating rudimentary uterus. In: Arregui ME, Fitzgibbons RJ Jr., Katkhouda N, McKernan JB, Reich H, editors. Principles of Laparoscopic Surgery: Basic and Advanced Techniques. New York: Springer; 1995. p. 537–679. 13. Soong YK, Chang FH, Lai YM, Lee CL, Chou HH. Results of modified laparoscopically assisted neovaginoplasty in 18 patients with congenital absence of vagina. Hum Reprod. 1996;11:200–203. 14. Luo GN. Vaginoplasty. Bei Jing: People’s Milit Med press. 2009 p. 20–25. 15. Green AE, Escobar PF, Neubaurer N, Michener CM, Vongruenigen VE. The Martius flap neovagina revisited. Int J Gynecol Cancer. 2005;15: 964–966. 16. Liu CY, Lang JH, Sun DW, et al. The clinical application of laparoscopy-assisted vaginoplasty with peritoneum. Progress Obstet Gynecol. 2006;15:353–355 (in Chinese). 17. Templeman CL, Hertweck SP, Levine RL, Reich H. Use of laparoscopically mobilized peritoneum in the creation of a neovagina. Fertil Steril. 2000;74:589–592. 18. Feng L, Zhu L, Lang JH, et al. The clinical analysis of 78 cases of congenital vaginal patients [In Chinese]. J Pract Obstet Gynecol. 2005;21:238–240. 19. Liao S, Zhou M, Lin J, et al. Prospective randomized comparison of laparoscopic peritoneal vaginoplasty with laparoscopic sigmoidvaginoplasty for treating congenital vaginal agenesis [In Chinese]. Chin J Minim Invas Surg. 2005;5:65–70. 20. Cao L, Wang Y, Li Y, Xu H. Prospective randomized comparison of laparoscopic peritoneal vaginoplasty with laparoscopic sigmoid vaginoplasty for treating congenital vaginal agenesis. Int Urogynecol J. 2013;24:1173–1179. 21. Liu Y, editor. Practical Gynecologic laparocopy surgery [In Chinese]. Bei Jing: Sci Tech Docum Press; 1999. p. 8–10. 22. Du M, Xu KK, Liao S, et al. The complications of laparoscopic peritoneal vaginoplasty (luohu operation) were analyzed [In Chinese]. China J Endosc. 2007;13:1165–1167. 23. Lin J, Junying Y. The clinical analysis of 93 cases of congenital vaginal [In Chinese]. Proceeding of Clinical Medicine. 2005;14:9–51. 24. Xu XJ, Zhang YR. Perioperative care of peritoneal vaginoplasty [In Chinese]. J Qilu Nurs. 2001;10:12–14. 25. Ismail IS, Cutner AS, Creighton S. Laparoscopic vaginoplasty: alternative techniques in vaginal reconstruction. Br J Obstet Gynaecol. 2006; 113:340–343.
Comparison of Two Techniques of Laparoscopy-Assisted Peritoneal Vaginoplasty Jie Wu, MSc, Ruixia Guo, MD*, Danxia Chu, MSc, Xinyan Wang, MSc, Liuxia Li, MD, Aiping Bian, MSc, Qian Zhao, MSc, and Huirong Shi, MD From the Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, Zheng Zhou, China (all authors).
ABSTRACT Neovagina creation is essential for patients with the Mayer-Rokitansky-Kuster-Hauser syndrome. We compared a technique involved the pushing down of the peritoneum with the technique of separating the peritoneum for laparoscopy-assisted peritoneal vaginoplasty. We collected patients with congenital absence of vagina who underwent laparoscopy-assisted peritoneal vaginoplasty of the First Affiliated Hospital of Zhengzhou University between January 2011 and May 2013. The 2 surgical groups (pushing group and separating group) were compared for various parameters. The values of the following parameters were significantly lower for the pushing group compared with the separating group: mean operating time (78 6 13 minutes vs 135 6 28 minutes), mean duration of hospitalization (12.9 6 2.7 days vs 18.0 6 3.8 days), mean cost of hospitalization (14 016 6 1640 RMB vs 18 783 6 2143 RMB), requirement for a drainage tube (4% vs 27%; c2 5 8.864), requirement for analgesic drugs (20% vs 40%; c2 5 3.977), and postoperative rehospitalization (3.3% vs 10.0% at 2 months and 6.7% vs 26.7% at 6 months; c2 5 4.268 and 5.196). Mean values for blood loss (57 6 19 mL vs 66 6 20 mL), time to pass gas (21 6 4 hours vs 23 6 7 hours), and length of the reconstructed vagina (9.0 6 0.4 cm vs 8.9 6 0.5 cm) were not significantly different between the 2 groups. In addition, mean postoperative Female Sexual Function Index score did not differ significantly between the 2 groups or among the 2 groups and a control group (27.0 6 4.8 vs 26.7 6 5.2 vs 27.9 6 4.5; p . .05). The technique involving pushing down of the peritoneum offers advantages of reduced cost, complications, hospitalization, operative time, and pain over the traditional technique. Sexuality approaches so-called ‘‘normal’’ sexuality. Journal of Minimally Invasive Gynecology (2016) 23, 346–351 Ó 2016 AAGL. All rights reserved. Keywords:
Laparoscopic vaginoplasty; Peritoneum; Surgery; Vaginal agenesis
Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome is characterized by congenital aplasia of the uterus and of the superior two-thirds of the upper vagina [1]. Clinically, MRKH syndrome can occur as an isolated syndrome (type I) or in combination with malformations in other organ systems (type II) [2]. Almost all patients with MRKH syndrome have normal secondary sex characteristics, a female karyotype of 46 XX, normal vulvar appearance, an absent vagina, and primary amenorrhea [3]. The condition is rare, with an incidence of 1:4500 in America [4] and 1.9% within the Chinese [5]. The authors declare no conflicts of interest. Corresponding author: Ruixia Guo, MD, Department of Obstetrics and Gynecology, The First Affiliated Hospital of Zhengzhou University, No. 1 East Construction Rd, Zhengzhou 450052, People’s Republic of China. E-mail: [email protected] Submitted September 12, 2015. Accepted for publication October 26, 2015. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2016 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.10.015
Surgery is recommended for vaginal reconstruction. The surgical techniques are designed to create a canal of adequate size oriented in the correct axis by developing the space between the bladder and rectum. Pratt [6] reported the use of sigmoid colon in vaginal reconstruction in 1961. Subsequently, harvesting free skin [7] and skin flaps [8] to form the lining of the neovagina were reported. Davydov [9] in 1969 and Rothman [10] in 1972 proposed a method for reconstructing the new vaginal lining with the peritoneum from the Douglas pouch. This traditional technique using the patient’s own peritoneum involves dissection to free the peritoneum and then pulling it down to the mucosa of the introitus. Laparoscopically assisted colpopoiesis from the pelvic peritoneum without pelvic dissection was introduced by Popp in 1992 [11], and is well presented in international publications [12]. Soong et al [13] first described peritoneum vaginoplasty with the aid of a laparoscope. In 2008, Luo [14] proposed improving this procedure with the use a
Wu et al.
Laparoscopy-Assisted Vaginoplasty
347
laparoscope along with a special peritoneal propeller, in what became known as the Luohu technique. Today, many surgeons are moving away from the traditional Davydov technique and making modifications of their own; however, few studies to date have compared the improved technique with the traditional technique through specific data evaluation. Our technique can be considered a modified version of the Luohu technique. We use a routine instrument, the clamp holding a gauze roll, to push down the peritoneum from the pelvic cavity to the introitus under laparoscopic guidance. In the present study, we sought to evaluate the safety and efficacy of this technique by comparing it with the traditional technique in terms of various parameters.
Assessment of Surgical Technique
Materials and Methods
Surgical Procedure
The same competent physician was responsible for the evaluation of perioperative parameters, such as blood loss, hospitalization costs, and patient recovery. Intraoperative blood loss was assessed by measuring the blood drawn by a suction device and weighing the blood-soaked gauze. Functional outcome was assessed using the FSFI, a brief and validated self-reporting questionnaire evaluating female sexual function. The FSFI encompasses 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Functional outcome was deemed very good at an FSFI score of R30, good at an FSFI score of 23 to 29, and poor at an FSFI score ,23. The FSFI scores for the 2 study groups were compared with those of the control group.
Study Design and Patients This study was designed as a retrospective investigation of the clinical characteristics of 60 patients with congenital absence of vagina who underwent laparoscopyassisted peritoneal vaginoplasty at the Obstetrics and Gynecology Department of the First Affiliated Hospital of Zhengzhou University between January 2011 and May 2013. The patients underwent vaginoplasty using the technique of pushing down the peritoneum or the technique of separating the peritoneum and were classified into 2 groups, the pushing group (n 5 30) and the separating group (n 5 30) accordingly. The choice of technique was made on a case-by-case basis, depending on the preference of attending surgeon. The same groups of doctors (a chief physician, an associate chief physician or attending physician, and 1 or 2 assistants) performed all of the procedures. In addition, data were acquired from 30 normal, age-matched women for comparison of Female Sexual Function Index (FSFI) scores with the study groups. These women were all family members of outpatients, and had no gynecologic disorders during the followup period. The study was approved by the Internal Review Board of the First Affiliated Hospital of Zhengzhou University, and informed consent was obtained from each enrolled patient. The mean patient age was 20 years (range, 17–24 years) in the pushing group and 21 years (range, 20–25 years) in the separating group (p 5 .15). Three patients (10%) in the pushing group and 2 patients (6.7%) group and separating group were married (p 5 .964). All enrolled patients had a normal 46 XX karyotype on chromosomal analysis, normal sex hormone levels, normal vulvar development, absence of vagina, and primary amenorrhea. Abdominal sonography revealed the presence of normal bilateral ovaries but an absent or primordial uterus in all cases. None of the patients had a history of pelvic surgery or pelvic tuberculosis or chronic pelvic inflammatory disease likely to cause extensive adhesions in the peritoneal cavity.
Preoperative Preparation Two days before surgery, the patient was restricted to a semiliquid diet and given oral metronidazole. On the day before surgery, the patient underwent intestinal lavage. A vaginal mold was prepared in-house and sterilized at high temperature. The procedure was performed with the patient under general anesthesia and in the supine lithotomy position. Pushing Group The first laparoscopic step was to establish pneumoperitoneum and advance a laparoscope through a subumbilical incision to carefully inspect the entire abdominal and pelvic cavity. Next, at the perineum, the dimple of the vulva was identified and diluted adrenaline in saline was injected therein; an H-shaped incision was then made at the site,
Fig. 1 Laparoscopic image showing the gauze rolls held by endoscopic nippers.
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Fig. 2
Fig. 4
Laparoscopic view from a point on the bottom of the pelvic cavity and behind the vestige of the uterus. The image shows the point where the peritoneum was pushed down to the orifice of the new canal using the routinely available clamp and gauze.
Intraoperative image showing a plus-shaped incision made to open the peritoneum.
and sharp and blunt dissection was performed into the rectovesical space up to a depth of approximately 8 cm. In the second laparoscopic step, a point at the base of the pelvic cavity behind the uterine vestige was identified. A clamp holding a gauze roll was then applied at this point by continuous and gradually increasing force to push the peritoneum down to the orifice of the new canal until the end of the gauze, with the intact peritoneum, was visible from the introitus (Figs. 1–3). Additional blunt dissection with the fingers was then performed under the peritoneum to prevent the rectal walls and vesicular walls from folding in, which can cause injury during dissection and suturing. Next, a plus sign–shaped incision was made to open the pushed-down portion of the peritoneum. The gauze was then removed (Figs. 4 and 5), and 4 stitches were placed in each quadrant with 2/0 absorbable suture to affix the peritoFig. 3 Schematic illustration of Figure 2, sagittal view.
neum to the incised margin of the introitus. Then the vaginal mold was inserted and fixed, and interrupted sutures were placed on the surface membrane of the bladder and rectum under laparoscopic guidance and drawn tightly to close the base of the pelvic cavity and the vault of the neovagina (Fig. 6). Separating Group The first laparoscopic step and subsequent perineal step were the same as those described for the pushing group. Thereafter, the peritoneum was freed by blunt dissection in all directions using separating pliers under laparoscopic guidance; the freed peritoneum could then be easily pulled down to the vaginal mucosa [12]. The edges of the opened
Fig. 5 Intraoperative image showing removal of the gauze.
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Fig. 6
Table 1
Intraoperative laparoscopic image showing closure of the bottom of the pelvic cavity and the vault of the neovagina.
Operative data by group
Parameter
Separating Pushing group group (n 5 30) (n 5 30)
122 6 29 214 6 35 Operating time, min, x6s 57 6 19 66 6 20 Blood loss, mL, x6s Requirement for drainage tube, %* 4 27 Time to pass gas, h, x6s 21 6 4 23 6 7 Requirement for analgesics, %y 20 40 Postoperative hospital stay, d, x6s 12.9 6 2.7 18.0 6 3.8 Hospitalization costs, RMB, x6s 14 016 6 1640 18 783 6 2143 * According to the size of the wound and extent of leakage, the surgeons reached a consensus regarding the need for an intraoperative drainage tube. y Patients’ requests for oral pain medication or injections for intolerable postoperative pain were taken into account; no repetitive statistics.
pelvic peritoneum were sutured to the mucosa at the introitus, and an anastomosis was established between the peritoneum and vaginal vestibulum. Finally, the superior peritoneal leaf was closed by interrupted sutures placed under laparoscopic guidance.
rating group (mean, 78 6 13 minutes vs 135 6 28 minutes; p 5 .017 and 4% vs 27%; c2 5 8.864; p 5 .012). Further, mean intraoperative blood loss was lower in the pushing group compared with the separating group, but not significantly so (57 6 19 mL vs 66 6 20 mL; p 5 .067). The operative parameters in the 2 groups are compared in detail in Table 1.
Postoperative Care
Postoperative Evaluation
As a general rule, the vaginal mold was changed each day and then removed 7 to 10 days after the operation. After daily disinfection, replacement was done at the hospital until the patient or her caretaker learned how to properly place, change, and disinfect the vaginal mold, at which point the patient was discharged. Sexually inactive patients were instructed to keep the mold in place day and night for 3 months after the surgery, and then to continue placement at night for 4 to 6 months.
The mean time to passing gas was lower in the pushing group than in the separating group, but not significantly so (21 6 4 hours vs 23 6 7 hours; p 5 .081). The separating group had significantly greater use of analgesics (40% vs 20%; c2 5 3.977; p 5 .046), length of hospital stay (mean, 18.0 6 3.8 days vs 12.9 6 2.7 days; p 5 .023), and hospitalization costs (mean, 18 783 6 2143 RMB vs 14 016 6 1640 RMB; p 5 .012).
Statistical Analysis Data were analyzed using SPSS for Windows version 16.0 (SPSS, Chicago, IL). The Student t test and the c2 test were used for analysis of quantitative variance and categorical variance, respectively. Enumeration data analysis was performed using ratios. Significance for all statistical tests was set at p 5 .05. Results Intraoperative Parameters The surgery was uneventful in all but 2 cases; 1 patient in each group experienced rectal injury, which was immediately recognized and repaired with no further complications. The operating time and requirement for a drainage tube were significantly lower in the pushing group than in the sepa-
Functional Outcome The rates of postoperative rehospitalization at 2 months and 6 months were significantly higher in the separating group compared with the pushing group (10% vs 3.3%; c2 5 4.268; p 5 .039 and 26.7% vs 6.7%; c2 5 5.196; p 5 .023, respectively). At 2 months after surgery, 1 patient from the pushing group and 2 patients from the separating group revisited the hospital because of vaginal polyps, and 1 patient from the separating group did so because of vaginal infection. Complications necessitating rehospitalization at 6 months after surgery included vaginal polyps in 2 patients of the pushing group and 4 patients of the separating group, vaginal infection in 1 patient of the separating group, vaginal adhesions in 2 patients of the separating group, and vaginal hernia in 1 patient of the separating group. All patients were assessed for sexual function using the FSFI. All of them reported attempting to have sexual
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Table 2 Assessment of sexual function by the FSFI in women who underwent peritoneal vaginoplasty and an age-matched control group
FSFI measure
Pushing group Separating group Control group (n 5 30) (n 5 30) (n 5 30)
No sexual activity 0 Desire score 4.4 6 0.9 Arousal score 4.4 6 1.0 Lubrication score 4.6 6 1.3 Orgasm score 4.2 6 1.2 Satisfaction score 4.6 6 1.0 Pain score 4.8 6 1.4 Full FSFI score 27.0 6 4.8
0 4.3 6 0.8 4.5 6 1.1 4.7 6 1.2 4.1 6 1.1 4.5 6 1.2 4.6 6 1.3 26.7 6 5.2
0 4.4 6 0.8 4.6 6 0.8 4.9 6 0.9 4.4 6 1.2 4.5 6 1.1 5.1 6 1.1 27.9 6 4.5
FSFI 5 Female Sexual Function Index. There were no significant differences among the 3 groups.
intercourse. The average delay between surgery and the attempt was 5.0 months (range, 1–18 months) in the pushing group and 5.7 months (range, 2–19 months) in the separating group, with no significant difference between the 2 groups. Table 2 presents the FSFI scores for the 2 study groups and the control group. The mean total FSFI score was 27.0 6 4.8 for the pushing group, 26.7 6 5.2 for the separating group, and 27.9 6 4.5 for the control group, with no significant difference among the 3 groups (p . .05). Figures 1–3 show the distribution of FSFI domain scores in the 3 groups. At 3 months after surgery, the reconstructed vagina had a mean length of 9.0 6 0.4 cm in the pushing group and 8.9 6 0.5 cm in the separating group, showing no significant difference between the 2 groups (p 5 .072). Discussion In MRKH syndrome, congenital absence of the vagina is associated with physiological abnormalities and emotional distress. Various methods of vaginal reconstruction have been proposed, including grafting of skin flaps [7], colonic segments [6], and the amniotic membrane and peritoneum [15], each of which has benefits and drawbacks [16]. All these surgical techniques are designed to create a vaginal canal of adequate size with appropriate length, orientation, and secretory ability [17]. The peritoneum is believed to be the ideal tissue for reconstruction [18], because it executes the functions of absorption, secretion, and defense similar to the vaginal mucosa; has good healing ability; and has a smooth, soft, and moist surface, which allows for a satisfying sexual experience [19]. With extensive advances in the field of laparoscopic surgery, laparoscopy-assisted peritoneal vaginoplasty has yielded good results and reportedly offers the advantages of minimal injury and good aesthetic and functional outcomes [20]. Because laparoscopic surgery is performed within the airtight abdominal cavity, environmental influ-
ences are minimal; the abdominal cavity is relatively stable and subjected to much less surgical trauma than occurs in open abdominal surgery [21]. Soong et al [13] first described performing peritoneal vaginoplasty with the aid of a laparoscope. In this technique, herein termed the traditional technique, the peritoneum is extensively dissected from the bladder and rectum, making it nearly a free graft. In the more recently developed laparoscopic peritoneal vaginoplasty (Luohu) technique, a special peritoneal propeller is used to push the peritoneum down toward the orifice of the new canal by applying continuous, gradually increasing force [22]. Our technique can be considered a modified version of the Luohu technique, with the main difference being the use of a readily available clamp with a gauze roll to push down the peritoneal fold for vaginoplasty. This technique does not require any dissection beneath the peritoneum from the pelvic cavity wall, forming a small wound that produces less postoperative pain. Most of the blood supply to the peritoneum is preserved, facilitating survival of the mobilized peritoneum. The technique has the advantages of technical simplicity, no need for specialized instruments, and lower cost. It also has several advantages in terms of operative parameters. The operating time is shorter, which reduces the risk of intraoperative anesthesia; the need for placement of an intraoperative drainage tube is lower, which reduces the pain associated with postoperative extubation; postoperative analgesic requirement is low, allowing for good compliance; the rate of postoperative rehospitalization is lower, indicating a lower rate of complications; and the length of hospital stay is lower, which reduces treatment costs. In our cohort, surgery was uneventful in all but 2 cases. One patient in each group experienced rectal injury, which was immediately recognized and repaired, with no further complications and no obvious abnormalities on subsequent follow-up. Whether performed with peritoneal dissection or not,carries the following risks (i.e. bladder, rectum or other pelvic structures injuries). The formed vaginal opening was between the urethra and the anus, if urethral opening position is low, the distance between the urethra and anus was shortened, the formed vaginal position may be biased toward vestibular by anal side, easy to cause rectum to crack. Rectal injury is the most common injuries in vaginoplasty, incidence of about 4%-5% [23]. No matter which kind of damage found, should immediately be repaired. All patients who underwent surgery using our technique demonstrated good healing after surgery and reported satisfaction with the neovaginal depth. A 2.5-cm diameter vaginal mold could be easily inserted in all patients, confirming patency of the neovagina. All patients who attempted sexual intercourse reported almost normal sexual function, as per the FSFI scores, with no significant difference among the 2 surgical groups and the normal control group, indicate functional recovery to normal levels.
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Proper nursing care after laparoscopic peritoneal vaginoplasty is of the utmost importance. When the first mold is replaced, the patient may experience marked pain, because the incision is not completely healed at that time [24]. Nevertheless, postoperative vaginal dilation is essential to prevent vaginal stenosis. Given our study’s retrospective design, the possibility of selection bias exists. But in this study, the same group of surgeons performed all operations using both techniques, and a total of 60 cases were studied, supporting the validity of our results. Short-term results for laparoscopy-assisted vaginoplasty have been encouraging [25]; however, further studies are needed to assess the long-term functional outcome of our technique and test its feasibility for widespread clinical application, especially in regions where highly specialized equipment may be unavailable. In conclusion, the new technique that involves pushing down the peritoneum for laparoscopy-assisted vaginoplasty offers the advantages of reduced costs, complications, hospitalization, operative time, and pain over the traditional technique. Sexuality approaches so-called ‘‘normal’’ sexuality. This technique shows great promise for widespread application. Acknowledgment This work was supported by the Key Technologies Research and Development Program of the Health Development Planning Commission of Henan Province (201403069). Supplementary Data Supplementary data related to this article can be found online at http://dx.doi.org/10.1016/j.jmig.2015.10.015. References 1. Pizzo A, Lagana AS, Sturlese E, et al. Mayer-Rokitansky-KusterHauser syndrome: embryology, genetics and clinical and surgical treatment. ISRN Obstet Gynecol. 2013;2013:628717. 2. Fiaschetti V, Taglieri A, Gisone V, Coco I, Simonetti G. Mayer-Rokitansky-Kuster-Hauser syndrome diagnosed by magnetic resonance imaging: role of imaging to identify and evaluate the uncommon variation in development of the female genital tract. J Radiol Case Rep. 2012; 6:17–24. 3. Giannesi A, Marchiole P, Benchaib M, Chevret-Measson M, Mathevet P, Dargent D. Sexuality after laparoscopic Davydov in patients affected by congenital complete vaginal agenesis associated with uterine agenesis or hypoplasia. Hum Reprod. 2005;20: 2954–2957. 4. Morcel K, Camborieux L. Programme de Recherches sur les Aplasies M€ ulleriennes, Guerrier D. Mayer-Rokitansky-K€uster-Hauser (MRKH) syndrome. Orphanet J Rare Dis. 2007;2:13.
351 5. Gao ZM, Huang XH, Zhang JF, et al. Clinically characteristic analysis in 339 patients with congenital absence of vagina. J Pract Obstet Gynecol. 2007;23:562–564. 6. Pratt JH. Sigmoidovaginostomy: a new method of obtaining satisfactory vaginal depth. Am J Obstet Gynecol. 1961;81:535–545. 7. Lesavoy MA. Vaginal reconstruction. Urol Clin North Am. 1985;12: 369–379. 8. Wee JT, Joseph VT. A new technique of vaginal reconstruction using neurovascular pudendal-thigh flaps: a preliminary report. Plast Reconstr Surg. 1989;83:701–709. 9. Davydov SN. Colpopoiesis from the peritoneum of the uterorectal space. Akush Ginecol (Mosk). 1969;45:55–57 (in Russian). 10. Rothman D. The use of peritoneum in the construction of a vagina. Obstet Gynecol. 1972;40:835–838. 11. Popp LW, Ghirardini G. Creation of a neovagina by pelviscopy. J Laparoendosc Surg. 1992;2:165–173. 12. Davis G, Redwine D, et al. Laparoscopic management of vaginal aplasia with or without functional noncommunicating rudimentary uterus. In: Arregui ME, Fitzgibbons RJ Jr., Katkhouda N, McKernan JB, Reich H, editors. Principles of Laparoscopic Surgery: Basic and Advanced Techniques. New York: Springer; 1995. p. 537–679. 13. Soong YK, Chang FH, Lai YM, Lee CL, Chou HH. Results of modified laparoscopically assisted neovaginoplasty in 18 patients with congenital absence of vagina. Hum Reprod. 1996;11:200–203. 14. Luo GN. Vaginoplasty. Bei Jing: People’s Milit Med press. 2009 p. 20–25. 15. Green AE, Escobar PF, Neubaurer N, Michener CM, Vongruenigen VE. The Martius flap neovagina revisited. Int J Gynecol Cancer. 2005;15: 964–966. 16. Liu CY, Lang JH, Sun DW, et al. The clinical application of laparoscopy-assisted vaginoplasty with peritoneum. Progress Obstet Gynecol. 2006;15:353–355 (in Chinese). 17. Templeman CL, Hertweck SP, Levine RL, Reich H. Use of laparoscopically mobilized peritoneum in the creation of a neovagina. Fertil Steril. 2000;74:589–592. 18. Feng L, Zhu L, Lang JH, et al. The clinical analysis of 78 cases of congenital vaginal patients [In Chinese]. J Pract Obstet Gynecol. 2005;21:238–240. 19. Liao S, Zhou M, Lin J, et al. Prospective randomized comparison of laparoscopic peritoneal vaginoplasty with laparoscopic sigmoidvaginoplasty for treating congenital vaginal agenesis [In Chinese]. Chin J Minim Invas Surg. 2005;5:65–70. 20. Cao L, Wang Y, Li Y, Xu H. Prospective randomized comparison of laparoscopic peritoneal vaginoplasty with laparoscopic sigmoid vaginoplasty for treating congenital vaginal agenesis. Int Urogynecol J. 2013;24:1173–1179. 21. Liu Y, editor. Practical Gynecologic laparocopy surgery [In Chinese]. Bei Jing: Sci Tech Docum Press; 1999. p. 8–10. 22. Du M, Xu KK, Liao S, et al. The complications of laparoscopic peritoneal vaginoplasty (luohu operation) were analyzed [In Chinese]. China J Endosc. 2007;13:1165–1167. 23. Lin J, Junying Y. The clinical analysis of 93 cases of congenital vaginal [In Chinese]. Proceeding of Clinical Medicine. 2005;14:9–51. 24. Xu XJ, Zhang YR. Perioperative care of peritoneal vaginoplasty [In Chinese]. J Qilu Nurs. 2001;10:12–14. 25. Ismail IS, Cutner AS, Creighton S. Laparoscopic vaginoplasty: alternative techniques in vaginal reconstruction. Br J Obstet Gynaecol. 2006; 113:340–343.