Abstract
Abstract
Objective:
We propose a mini-invasive technical variant for laparoscopic myomectomy, which is currently less invasive and more feasible.
Study Design:
This was a prospective, controlled, randomized trial, involving 170 patients, who underwent laparoscopic myomectomy. Patients were randomized into two groups: Group A (n=98) underwent standard laparoscopic myomectomy, and Group B (n=72) underwent the mini-invasive technique. The current mini-invasive variant is performed with a 10-mm umbilical trocar and only two 5-mm ancillary trocars. Morcellation is transumbilical: a 0° 5-mm optical system is used and is inserted either in the left or in the right iliac trocar according to the surgeon's preference.
Results:
The degree of surgical difficulty, evaluated using a visual analog scale (VAS), was similar in the two groups (P=nonsignificant). Postoperative pain measured on a VAS scale showed there was less pain experienced in patients in Group B than in Group A (P<.01). Esthetic results measured on a VAS scale showed a higher compliance for patients in Group B than Group A (P<.01).
Conclusions:
The mini-invasive laparoscopic myomectomy described is, in our opinion, currently less invasive and more feasible than techniques usually used. Finally, this technique is a valid approach for the surgeon, and it gives women very acceptable aesthetic results.
Introduction
Laparoscopic myomectomy is recommended in the removal of pedunculated, subserosal, intramural, and intraligamentous myomas in women who desire to preserve fertility.1,3 Laparoscopic myomectomy is not only feasible, but it is also associated with the recognized advantages of minimal access surgery, including shorter hospitalization and more rapid recovery times.4–7
Despite its proven feasibility, surgical expertise is required for the safe and time-efficient removal of large myomas from the abdomen. 4 Various methods of minimally invasive surgery have been described, such as laparoscopic, single-incision laparoscopic, minilaparotomic, or laparoscopically assisted myomectomy. 1 Thanks to technical improvements and increasing experience, surgeons are attempting to decrease the number of abdominal incisions and visible scars. 1 The experience of 20 years of laparoscopic myomectomy (approximately 4000 interventions) has allowed us to refine a variant that maximizes the already considerable benefits of laparoscopy in terms of surgical trauma, esthetic results, and patient compliance.
In this prospective, controlled, randomized study, we compare a mini-invasive technique of laparoscopic myomectomy with traditional laparoscopic myomectomy, and we provide surgical analysis and operative outcomes.
Subjects and Methods
Setting
These studies were performed at the Department of Obstetrics, Gynaecology and Reproductive Medicine of the Second University of Naples, Naples, Italy, and at the Operative Unit of Obstetrics and Gynaecology, Highly Specialized National Hospital “San Giuseppe Moscati,” Avellino, Italy.
Population study
In total, 170 patients who underwent laparoscopic myomectomy in the period from January 2009 until January 2011 were enrolled in this study. All the patients gave their written informed consent. The study protocol received institutional review board approval before the beginning of the study, in accordance with the Code of Ethics of the Declaration of Helsinki.
In order to obtain results comparable in term of patient selection and numbers and diameters of myoma, only women with up to seven intramural myomas and the largest myoma diameter of ≤8 cm were enrolled. All patients underwent transvaginal ultrasonography within the 2 weeks before surgery to evaluate size, location (with respect to uterine layers), and position (with respect to the uterine axis) of the myomas.
Exclusion criteria for the study were previous uterine surgery, additional diseases requiring surgical treatment (such as endometriosis, tubal surgery, or appendicitis), body mass index ≥29 kg/m2, contraindications for general anesthesia, and psychiatric disorders precluding informed consent. No patient included in the study underwent medical treatment for ovarian suppression before surgery.
Data collection
Demographic data of the patients included in the study were collected on the day before surgery. For the purpose of the study, hemoglobin (Hb) concentration was determined on the day before surgery and at 24 hours after surgery; the difference in Hb concentration (ΔHb) was calculated in order to estimate intraoperative blood loss.
All surgical procedures were recorded. Operative times were determined by reviewing the surgical procedures using Final Cut Pro (Apple®, Inc., Cupertino, CA) and were calculated from the beginning of the operation (after the insertion of the trocars) until the removal of the trocars. At the end of each surgical procedure, the surgeons evaluated the degree of surgical difficulty by use of a visual analog scale (VAS) ranging from 1 (low difficulty) to 10 (high difficulty) as previously described by other authors. 3 At the moment of discharge, patients were asked to evaluate pain on a VAS, and after 30 days they were asked to describe esthetic results on a VAS.
Randomization
Computer-based randomization by a statistician determined into which of the two groups patients fell: Group A (n=98), standard laparoscopic myomectomy; or Group B (n=72), mini-invasive technique.
Surgical procedure
Three surgeons (I.A., L.C., and M.A.) performed the surgical procedures. These procedures were performed with the patients under general anesthesia, which was induced and maintained as previously described.2,8 As in most laparoscopic procedures carried out in our centers, the patient is placed in a modified lithotomic position, with hands placed along the body, legs slightly flexed and abducted, and the pelvic floor protruding a few centimeters from the operating table to allow easy mobilization of the uterus, with an intrauterine device.
Either an open laparoscopy or a Veress needle classic technique was used for laparoscopy, and a 10-mm port was inserted through the umbilicus to introduce the laparoscope. Pneumoperitoneum was obtained with carbon dioxide insufflation until 10 mm Hg.
After randomization, patients of Group A underwent standard laparoscopic myomectomy with three operative ports as previously described by other authors2,3 (Fig. 1A). Specifically, a 10-mm intraumbilical port is used to introduce the laparoscope, and three operative additional ports—a 10-mm port on the left-hand side, a 5-mm port in the central suprapubic region, and a 5-mm port on the right-hand side of the patient—are used. After myoma enucleation and suture of uterine defects, morcellation is performed through the 10-mm left-hand-side trocar with a 10-mm morcellator (Rotocut™ G1 tissue morcellator; Karl Storz GmbH & Co. KG, Tuttlingen, Germany).
Patients of Group B were subjected to the current mini-invasive variant with only two 5-mm ancillary trocars positioned under laparoscopic vision, in the right and left pelvic region, 2 cm above and 1 cm medially to the anterior superior iliac spine (Fig. 1B).
The operating technique, in the phases that precede suture and morcellation of the myomas, is not very dissimilar from that of the standard laparoscopic myomectomy. However, two types of 5-mm instruments are needed for this technique: 5-mm traction instruments and a bipolar cutting and coagulation device. We mainly use the 5-mm myoma drill and the 5-mm Museaux (Karl Storz GmbH & Co. KG) as the traction instrument and the PKS™ PlasmaSpatula bipolar electrosurgical device (Gyrus Medical Inc., Minneapolis, MN). Suturing and morcellation for Group B are described below.
Suture
In order to do the suture, a 1-Monocryl™ (poliglecaprone 25; Ethicon Endo-Surgery, Cincinnati, OH) (½-circle and 36-mm) needle is introduced into the abdominal cavity directly through the skin breech, while the left iliac trocar is temporarily removed. Then, the surgeon can perform either extra- or intracorporeal knots, introducing laparoscopic instruments directly through the skin breech.
Morcellation
The 10-mm optical system is now replaced by a 0° 5-mm system, which is inserted either in the left or in the right iliac trocar, depending on the surgeon's preference. The 10-mm Rotocut G1 tissue morcellator is inserted in the umbilical breech. The morcellation is therefore transumbilical (Fig. 1C).
After this phase is completed, the 10-mm laparoscope is repositioned in the umbilical port in order to allow peritoneal washing and other necessary maneuvers. After trocar removal, surgical laparoscopic breeches are closed with biological surgical glue (synthetic surgical glue; Glubran® 2; GEM S.r.l., Viareggio, Italy) (Fig. 2).
Postoperative scars in a patient who had undergone mini-invasive laparoscopic myomectomy.
Statistical analysis
A power calculation had been undertaken to determine an appropriate sample size for this noninferiority study. We calculated the mean (±standard deviation) time required to perform the intervention of the uterine wall defect in the last 100 laparoscopic myomectomies performed by the three surgeons (I.A., L.C., and M.A.), which was 59.4±9.2 minutes.
A two-sided test power calculation was performed given that the minilaparoscopic myomectomy was expected to be as fast as the standard technique. The standard deviation of the time required for the 100 laparoscopic myomectomies performed by the three surgeons (9.2 minutes) was the sigma value used. This power calculation indicated that 22 patients in each group would be necessary to detect a 15% difference in the time required to perform the myomectomy with a power ≥90% at a 1% level of significance. Data were analyzed by using Student's t test and chi-squared test for parametric variables, whereas the Mann–Whitney U test was used for nonparametric variables. Statistical calculations were performed using Statistical Package for the Social Sciences (SPSS) software (version 17.0; SPSS Inc., Chicago, IL). A value of P<.05 was considered statistically significant.
Results
The demographic characteristics of the patients, given in Table 1, were globally homogeneous. All procedures were completed by laparoscopy with the technique used at the outset, and no conversion to laparotomy was required. No major complications, such as ureteric injury, bladder injury, or bowel injury, occurred in any case. No significant difference was observed in operative times (median±standard deviation [95% confidence interval]) among patients in Group A (58.4±7.1 [35.4–62.8] minutes) and in Group B (57.2±9.3 [34.7–70.1] minutes) (Table 2).
Continuous variables were expressed as mean±standard deviation values (95% confidence interval), whereas discrete variables were expressed as frequencies and percentages.
P<.05 was considered statistically significant.
Mean±standard deviation (range).
BMI, body mass index; NS, difference not significant.
Data are median±standard deviation values (95% confidence interval). Degree of surgical difficulty, postoperative pain, and esthetics results by the patient were rated on a visual analog scale.
P<.05 was considered statistically significant.
NS, difference not significant.
Intraoperative blood loss was similar in the two groups: Group A, ΔHb=0.4 g/dL; Group B, ΔHb=0.3 g/dL (P=nonsignificant). Blood transfusion was not required in any case. The degree of surgical difficulty (median±range [95% confidence interval]), evaluated by VAS, was similar in the two groups: Group A, 7±2 (5–9); Group B, 7±3 (5–10) (P=not significant).
Postoperative pain measured on a VAS showed less pain was experienced by patients in Group B than in Group A: 5±2 (3–7) versus 6±2 (4–8) (P<.01).
Esthetic results measured on a VAS showed a higher compliance for patients in Group B than in Group A: 9±1 (8–10) versus 7±2 (5–9) (P<.01).
Discussion
Over the past 10 years, several studies have demonstrated that laparoscopic myomectomy has several advantages over laparotomic and minilaparotomic approaches, including lower operative Hb drop, shorter hospital stays, less postoperative pain, and faster recovery times.1,8 On the other hand, laparoscopy itself is a surgical technique that may present significant challenge to the surgeons. 4 The suture of the uterine wall defect is probably the most difficult and time-consuming task for surgeons performing laparoscopic myomectomy.1,8
The present study compared a mini-invasive technique of laparoscopic myomectomy with traditional laparoscopic myomectomy, providing surgical analysis and operative outcomes. We showed that no significant difference exists between the two techniques in operative times and degree of surgical difficulty, although patients treated with a minilaparoscopic approach experienced less postoperative pain and thought esthetic results were better. The use of a suitable electrosurgical bipolar device and an adequate traction instrument let us complete all the minilaparoscopic procedures without converting to a standard laparoscopic myomectomy or to a laparotomy.
A brief look at suture and morcellation surgical times of the minilaparoscopic myomectomy reveals that these procedures are no more difficult than in traditional laparoscopic myomectomy. Namely, in order to do the suture, the needle is introduced by removing the left 5-mm trocar, and this allows the surgeon to work more efficiently and to perform either extra- or intracorporeal knots with ease.
The transumbilical morcellation technique, performed by using a 0° 5-mm optical system introduced in the left 5-mm trocar, allows the surgeon to operate in a comfortable position, and, in addition, this method keeps the morcellator blade at a safe distance from the uterus and bowel. Additionally, the telescope introduced in the left 5-mm trocar allows optimal spatial vision. As a result, the use of a mini-invasive technique with two 5-mm ancillary trocars allowed minimum skin, fasciae, muscular, and peritoneal damage in patients, thus resulting in lower postoperative pain.
In addition, the current use of two 5-mm ancillary trocars for laparoscopic myomectomy gives women very acceptable esthetic results. Indeed, our data perfectly match those of a striking recent survey by Bush et al., 9 which refuted the claim that single-incision laparoscopy is esthetically preferable to traditional laparoscopy incisions. By a significant margin, patients in the survey preferred the traditional incisions, and the robotic incision configuration was given a strong negative preference. 9
The potential advantages of the present minilaparoscopic myomectomy over conventional laparoscopy include better cosmetic results, the need for fewer and smaller trocar incisions, and a possible decrease in morbidity related to visceral and vascular injury during accessory trocar placement.
Additionally, the lateral 5-mm incisions result in the reduction of postoperative pain. Another advantage of minilaparoscopic myomectomy in women is that the approach may be psychologically more attractive for patients in terms of body image. With minimized scarring and potential multiport-site complications, this technique may enhance surgical outcomes and postoperative quality of life.
In conclusion, the mini-invasive laparoscopic myomectomy described here is, in our opinion, currently less invasive and more feasible. Summing up, this technique is a valid approach for the surgeon and gives the female patients very acceptable esthetic results.
Footnotes
Acknowledgments
We thank Mrs. Lina Ronga for her valuable help.
Disclosure Statement
No competing financial interests exist.