TECHNIQUES AND INSTRUMENTATION

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1 TECHNIQUES AND INSTRUMENTATION FERTILITY AND STERILITY VOL. 81, NO. 4, APRIL 2004 Copyright 2004 American Society for Reproductive Medicine Published by Elsevier Inc. Printed on acid-free paper in U.S.A. Use of the LAP DISK (abdominal wall sealing device) in laparoscopically assisted myomectomy Fuminori Taniguchi, M.D., Tasuku Harada, M.D., Tomio Iwabe, M.D., Souichi Yoshida, M.D., Masahiro Mitsunari, M.D., and Naoki Terakawa, M.D. Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago, Japan Objective: To evaluate the efficacy of an abdominal wall sealing device (the LAP DISK) used during laparoscopically assisted myomectomy (LAM). Design: Retrospective study. Setting: Tottori University Hospital, Yonago, Japan. Patient(s): All 43 patients who underwent LAM using the LAP DISK. Intervention(s): Ultrasonography and magnetic resonance imaging. Main Outcome Measure(s): Treatment strategy, operative outcome, and postoperative pregnancy rate. Result(s): Weight and size of the myomas removed ranged from g (mean: g) and 2 10 cm (mean: 5.4 cm). Mean blood loss was 42.3 ml. Half of the 18 patients who had been diagnosed with primary infertility for 2 years became pregnant without postoperative assisted reproductive techniques. Conclusion(s): The LAP DISK, a useful device for LAM, allows surgeons to remove myomas safely and repair uterine defects effectively while minimizing blood loss and trauma. (Fertil Steril 2004;81: by American Society for Reproductive Medicine.) Key Words: LAP DISK, laparoscopically assisted myomectomy, infertility Received June 10, 2003; revised and accepted September 2, Reprint requests: Fuminori Taniguchi, M.D., Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago , Japan (FAX: ; tani4327@ grape.med.tottori-u.ac.jp) /04/$30.00 doi: /j.fertnstert The use of myomectomy rather than hysterectomy to treat uterine myoma has increased because it has been shown to maintain fertility and improve reproductive potential. Laparoscopic myomectomy also may reduce the risk of postoperative adhesions compared with abdominal myomectomy, which is a considerable advantage in infertile patients (1, 2). Total laparoscopic myomectomy (TLM), which was developed in the early 1990s to treat subserous and intramural myomas (3, 4), has many advantages over laparotomy (Lapt), including shortened hospital stay and convalescence and less postoperative pain. Total laparoscopic myomectomy, however, still has considerable problems: the procedure is technically difficult, particularly suturing endoscopically. Hence, bleeding is difficult to control and often necessitates advancing to abdominal myomectomy. Uteroperitoneal fistula formation and uterine dehiscence are also risks after TLM (5, 6). Laparoscopically assisted myomectomy (LAM) has also been used as a kind of minilaparotomy to enucleate myoma nodules and close uterine myometrium and serosa. Laparoscopically assisted myomectomy has been described before, and its advantages compared with Lapt and TLM have been reported (7). New laparoscopic techniques to treat gynecological disease have been developed rapidly in recent years. In 2000, we introduced the LAP DISK, which is an abdominal wall sealing device, for use during a LAM. The LAP DISK enables surgeons to insert their hands or surgical instruments into the abdominal cavity to examine and retract organs while maintaining pneumoperitoneum and to seal a skin incision after resecting the myoma. The LAP DISK is made of two plastic circles (10-cm diameter) and a flexible wire ring that are connected with latex membranes. The use of LAP DISK enables surgeons to open and shut the patient s abdominal cavity at any time. This procedure is 1120

2 FIGURE 1 (A) Structure of the LAP DISK. (B) Opened LAP DISK. (C) The LAP DISK was introduced inside the abdominal incision, and the patient s uterus appeared in the DISK. (D) The LAP DISK was closed to form a seal with the skin incision, and a 10-mm cannula was placed. Taniguchi. Use of the LAP DISK in LAM. Fertil Steril intermediate to laparotomy and TLM. To circumvent the several limitations associated with TLM and retain its advantages, we began using the LAP DISK. The aim of this study was to assess the efficacy of a combined operative laparoscopy and minilaparotomy technique using the LAP DISK. MATERIALS AND METHODS We retrospectively evaluated the records of 43 patients who underwent LAM with a LAP DISK at Tottori University Hospital from April 2000 to December About the patient selection criteria, the operative indication for this procedure was decided by the existence of the symptomatic subserous or intramural myomas within 10-cm diameter. They were all patients in whom we used the LAP DISK. All patients had subserous or intramural myomas measuring 2 10 cm in diameter, which were the largest myoma in each patient, and the accumulated weight of all myomas was 40 to 700 g. Mean patient age was 32.2 years (range, years). No patient had previous abdominal or pelvic surgery. In this study, all procedures were completed without requiring full laparotomy. Preoperatively, patients underwent pelvic examination, ultrasonography, and magnetic resonance imaging. Also, 35 patients (81.4%) received preoperative GnRH agonist (Leuprin; Takeda Pharmac. Co., Ltd, Tokyo, Japan) by injection for 2 to 6 months. The GnRH agonist reduced tumor size by an average of 42.8%, using the three-dimensional ultrasonography measurement. This study was approved by our institutional review board. We had been given the informed consent to use the LAP DISK by all patients. All operations were performed under general endotracheal anesthesia with the patient in the Trendelenburg position. The bladder was catheterized, and a uterine retractor was placed transcervically. A 4-cm horizontal incision was made in the pubic area to insert the LAP DISK (Hakko Inc., Tokyo, Japan; Fig. 1A). The fascia and the peritoneum were incised transversely. After the LAP DISK was introduced into the abdominal cavity (Fig. 1B and C), the disk was closed, then CO 2 gas was introduced through a 10-mm principal cannula to fill the abdominal cavity (Fig. 1D). By means of laparoscopic visualization through this cannula, a second 5-mm trocar and cannula was safely inserted through the subumbilical incision. A 5-mm laparoscope was reintroduced through the subumbilical cannula. Using laparoscopic visualization, two ancillary 5-mm cannulas were placed in FERTILITY & STERILITY 1121

3 both sides of the lower quadrant. Once cannula placement was complete, the location of all myomas was identified, and pelvic adhesions were lysed as necessary. After completing these procedures, the CO 2 insufflator and video laparoscopic system were turned off temporarily. A suture was applied as a guide to apply traction to the myoma during dissection. To decrease uterine bleeding, 3 5 ml of Vasopression (Sankyo Co. Ltd., Tokyo, Japan) at a concentration of 0.2 U/mL was injected into the myometrium around the myoma nodules. A horizontal incision was made with monopolar electrocautery over the uterine serosa until the capsule of the leiomyoma was reached. Enucleation was made along the cleavage plane separating the myoma nodule and surrounding the myometrium. Uterine bleeding was easily and safely controlled with electrocautery through the LAP DISK. The myometrial or subserous defects were repaired with 2-0 or 3-0 Monocryl (Monocryl; Johnson and Johnson Co., Ltd, Tokyo, Japan). The hysterotomy was usually sutured in two or three layers when the myoma was located deeply or the uterine cavity was opened. If the stalk of a subserous myoma was thin, the uterine wound was closed with one muscular layer. Myoma extraction was performed by the suprapubic route through the LAP DISK, either directly or using the electric morcellator, depending on the size of the myoma. After washing the pelvic cavity with saline, Interceed (Johnson and Johnson Medical, New Brunswick, NJ) or TachoComb (Torii Pharmac. Co., Ltd, Tokyo, Japan) was applied over the uterine wound to prevent adhesion between the uterine serosa and other organs. After the CO 2 insufflator and video-laparoscopic system were resumed, a concomitant adnexal cystectomy and adhesiolysis, and particularly in infertile patients, chromopertubation was performed. The abdominal horizontal incision was sutured at the level of the fascia to prevent herniation. The other puncture sites were closed with 3-0 nylon thread. RESULTS All 43 patients studied underwent laparoscopic myomectomy with the LAP DISK. Ninety-two myomas with a diameter of 20 mm that were located in the intramural and subserosal were removed. The indications for LAM and the main characteristics of the study population are presented in Table 1. Mean blood loss and operating time were 42.3 ml (range: ml) and minutes (range: minutes), respectively. Mean total accumulated weight of operative specimens and size of the largest myoma was g (range: g) and 5.4 cm (range: 2 10 cm). The average postoperative hospital stay was 5.7 days (range: 2 10 days). Although there was no complication necessitating longer stay, some patients desired longer hospitalization. Twelve of the 43 patients underwent concomitant adnexal cystectomy and adhesiolysis. Eight patients had electrocautery to treat endometriosis. In no case was laparotomy necessary. We excluded the 8 patients who required ICSI therapy for oligo-asthenospermia from 26 infertile patients. Intrauterine pregnancy was achieved in 50.0% (n 18) of infertile patients. Four of the 9 patients (44.4%) had a vaginal deliv- TABLE 1 Main characteristics of the study population (n 43). Characteristics n Mean SD % Age (year SD) Indication for LAM Pelvic pain Sense of abdominal distension Menorragia or metrorragia Infertility Past abortion or premature delivery Size of the largest myoma (cm SD) cm cm Total no. of myomas 92 No. of myomas SD/patient Type of the largest myoma No. of subserous No. of intramural Leiomyoma weight (grams SD) Operative time (min SD) Blood loss (ml SD) Postoperative hospital stay (days SD) Taniguchi. Use of the LAP DISK in LAM. Fertil Steril Taniguchi et al. Use of the LAP DISK in LAM Vol. 81, No. 4, April 2004

4 ery without complications. Five had a cesarean section. Of these, none had any sign of adhesion formation at the myomectomy sites. No cases of uterine rupture during pregnancy or labor occurred among the patients who were included in this study. No antepartum or intrapartum complications occurred. DISCUSSION We showed that LAM with the LAP DISK combines the benefits of simplicity, speed, and better anatomic reconstruction with a quicker recovery time. This procedure is technically less difficult than TLM and allows better closure of the uterine defect. Total laparoscopic myomectomy is sometimes difficult and time consuming, requiring advanced skills to enucleate and morcellate the myoma nodule and repair the uterine defect without tactile sensation. The LAP DISK provides a quick transition from laparoscopic procedures to Lapt and reverse change is also easily performed. Operative laparoscopy is increasingly being used and provides several advantages, such as shorter hospital stay and recovery, and decreased de novo adhesion formation. With the laparoscopic route, it is impossible to palpate the myometrium, which means that small intramural nuclei that do not deform the uterine serosa can be overlooked, resulting in incomplete resection. In contrast, LAM with a LAP DISK allows surgeons to assess the pelvic cavity, identify the number and location of tumors, perform adhesiolysis, and treat endometriosis by laparoscopic surgery. This method is also applicable for laparoscopic procedures for a certain size of resected specimen, with malignant disease, or with frequent complications, such as intraoperative massive bleeding. Dubuisson et al. (8) reported that the risk of conversion to an open procedure after TLM was greater among patients with myoma measuring 50 mm at ultrasonography and among patients with intramural or anterior myoma. In this study, the use of the LAP DISK made it possible to resect retroperitoneal and large myomas (10-cm diameter). The risk of uterine rupture is a major concern after any surgery involving the muscularis layer (9, 10). The difficulty in adequately closing all layers using a laparoscopic approach may contribute to a higher risk of uterine rupture and fistula. Some investigators have emphasized that TLM does not provide adequate uterine repair in cases of intramural myoma (11, 12). Dubuisson et al. (13) reported that the incidence of uterine rupture after TLM is relatively low and that the risk of uterine rupture specifically due to TLM was 0.5% among 293 pregnancies. Indeed, any technical deficiency affecting this repair may result in uterine rupture during a subsequent pregnancy. Therefore, the suture must always take up the full depth of the edges of the hysterotomy and result in total contact over the whole of the myomectomy defect to avoid secondary constitution of hematoma inside the myometrium. The presence of uterine myoma associated with infertility may reduce uterine contractility, affecting sperm migration, and vascular changes can disturb the endometrial function and may hinder implantation. Stovall et al. (14) suggested that patients undergoing IVF and ET programs may benefit from myomectomy before ovarian stimulation. However, because of the presence of concomitant factors, it has been difficult to identify which myomas play a role in infertile patients. In their 2-year follow-up period, Ribeiro et al. (15) and Dubuisson et al. (16) reported that intrauterine pregnancy rates after TLM were 65.4% and 43.9%, respectively. Reproductive outcome after LAM was only examined in the Nezhat et al. (7) study. Those investigators stated that 4 of 14 infertile women (28.5%) conceived after LAM. The cumulative pregnancy rate of the present study is 50.0% (9/18). The number of patients in both studies is still small; further studies with a large number of patients will be required. Nezhat et al. (7) summarized that the operative time and the intraoperative blood loss were comparable among LAM, TLM, and Lapt, although the mean size of resected leiomyoma in TLM was smaller than those of LAM and Lapt. Silva et al. (17) also stated that blood loss in TLM and LAM was comparable to Lapt. The present study showed that the operative time in LAM with LAP DISK was not long and that the amount of blood loss was extremely small (Table 1). In summary, our results suggest that surgeons can effectively remove myomas and repair uterine defects through the LAP DISK. This allows safe surgery to be performed by most gynecologists rather than only by those who have extensive experience with laparoscopic surgery. Quick transition between laparoscopy and laparotomy via the LAP DISK may also provide surgeons with a new operative field for more complicated surgical procedures. References 1. Bulletti C, Polli V, Negrini V, Giacomucci E, Flamigni C. Adhesion formation after laparoscopic myomectomy. J Am Assoc Gynecol Laparosc 1996;3: Dubuisson JB, Fauconnier A, Chapron C, Kreiker G, Norgaard C. Second look after laparoscopic myomectomy. Hum Reprod 1998;13: Dubuisson JB, Lecuru F, Foulot H, Mandelbrot L, Aubriot FX, Mouly M. Myomectomy by laparoscopy: a preliminary report of 43 cases. Fertil Steril 1991;56: Nezhat C, Nezhat F, Silfen SL, Schaffer N, Evans D. Laparoscopic myomectomy. Int J Fertil 1991;36: Nezhat C, Nezhat F. Letter to the editor: Laparoscopic myomectomy complications. Int J Fertil 1991;37: Harris WJ. Uterine dehiscence following laparoscopic myomectomy. Obstet Gynecol 1992;80: Nezhat C, Nezhat F, Bess O, Nezhat CH, Mashiach R. Laparoscopically assisted myomectomy: a report of a new technique in 57 cases. Int J Fertil Menopausal Stud 1994;39: Dubuisson JB, Fauconnier A, Fourchotte V, Babaki-Fard K, Coste J, Chapron C. Laparoscopic myomectomy: predicting the risk of conversion to an open procedure. Hum Reprod 2001;16: Friedman W, Maier RF, Luttkus A, Schafer AP, Dudenhausen JW. Uterine rupture after laparoscopic myomectomy. Acta Obstet Gynecol Scand 1996;75: Perosi M, Perosi MA. Spontaneous uterine rupture at thirty-three weeks subsequent to previous superficial laparoscopic myomectomy. Am J Obstet Gynecol 1997;177: Harris WJ. Uterine dehiscence of following laparoscopic myomectomy. Obstet Gynecol 1992;80: Nezhat C. The cons of laparoscopic myomectomy in women who may reproduce in the future. Int J Fertil 1996;41: FERTILITY & STERILITY 1123

5 13. Dubuisson JB, Fauconnier A, Deffarges JV, Norgaard C, Kreiker G, Chapron C. Pregnancy outcome and deliveries following laparoscopic myomectomy. Hum Reprod 2000;15: Stovall DW, Parrish SB, Van Voorhis BJ, Hahn SJ, Sparks AET, Syrop CH. Uterine leiomyomas reduce the efficacy of assisted reproduction cycles: results of a match follow-up study. Hum Reprod 1995;13: Ribeiro SC, Reich H, Rosenberg J, Guglielminetti E, Vidali A. Laparoscopic myomectomy and pregnancy outcome in infertile patients. Fertil Steril 1999;71: Dubuisson JB, Fauconnier A, Chapron C, Kreiker G, Norgaard C. Reproductive outcome after laparoscopic myomectomy in infertile women. J Reprod Med 2000;45: Silva BA, Falcone T, Bradley L, Goldberg JM, Mascha E, Lindsey R, et al. Case-control study of laparoscopic versus abdominal myomectomy. J Laparoendosc Adv Surg Tech A 2000;10: Taniguchi et al. Use of the LAP DISK in LAM Vol. 81, No. 4, April 2004