Minimally invasive surgical techniques have been championed as a result of their association with less postoperative pain, decreased morbidity, and a speedier recovery when compared with open abdominal procedures.1 However, methods for tissue extraction during minimally invasive gynecologic surgery have recently come under increased scrutiny. Electromechanical morcellation was first introduced in 1993 to improve speed and ease of tissue extraction without the need of a laparotomy.2,3
In addition to the intrinsic risk of visceral or vascular injury associated with operation of the device itself,4 there is concern for tissue dissemination during intracorporeal, or “open,” power morcellation. Fragments of tissue that are not retrieved may result in postoperative infection, pain, and the need for reoperation.5,6 Moreover, two retrospective studies estimate that disseminated parasitic leiomyomatosis occurs after 0.1–1% of cases involving laparoscopic power morcellation of uterine leiomyoma tissue.7,8 Perhaps most alarming, intracorporeal morcellation has also been reported to result in the seeding of occult malignancies.9–12 The unintended morcellation of uterine leiomyosarcoma is of particular concern, because this condition may be difficult to differentiate from the much more common entity of benign leiomyoma tumors preoperatively. Procedure-related fragmentation and intraperitoneal dissemination of leiomyosarcoma tissue has been associated with upstaging of disease and worsened outcomes.13,14,15
In this report, we describe an innovative technique to perform morcellation of uterine and myoma tissue in a contained fashion within an insufflated isolation bag. This practice allows patients to benefit from a minimally invasive surgical approach while potentially minimizing complications of laparoscopic specimen retrieval.
MATERIALS AND METHODS
We present a cohort study of patients who underwent uterine tissue morcellation within an insufflated isolation bag from January 2013 to April 2014 at Fairview Ridges Hospital (Burnsville, Minnesota) and from January 2014 to April 2014 at Johns Hopkins Hospital (Baltimore, Maryland), Massachusetts General Hospital, and Brigham and Women's Hospital (both in Boston, Massachusetts). The physicians who contributed cases to this study are all high-volume surgeons experienced in advanced minimally invasive gynecologic surgical techniques; most completed fellowship training in gynecologic oncology or minimally invasive gynecologic surgery.
All patients in whom morcellation was planned at the time of a minimally invasive myomectomy or hysterectomy during the study period were offered contained morcellation in an isolation bag and included in the study. Data from Fairview Ridges Hospital were collected by retrospective chart review; all other institutions performed data collection on a prospective basis. Exclusion criteria were known or suspected malignancy. The preoperative workup to evaluate risk of genital tract cancer included a recent Pap test, endometrial sampling in cases of abnormal uterine bleeding, and imaging with either pelvic ultrasonography or magnetic resonance imaging. The only exception to routine endometrial sampling was in isolated cases of inability to obtain a specimen after endometrial ablation. Demographic information abstracted from the medical record included patient age, race, obstetric history, body mass index (calculated as weight (kg)/[height (m)]2), surgical history, and indication for surgery. Perioperative information collected included mode of access, type of procedure(s) performed, operative time (defined as time from incision to closure), estimated blood loss (defined as surgeon estimate that was recorded in the operative record), specimen weight, intact status of isolation bag postmorcellation (obtained by visual inspection of the isolation bag by the surgeon), length of hospital stay, intraoperative complications (defined as visceral, vascular, or nerve injury; estimated blood loss greater than 1,000 mL; or serious anesthesia complication), postoperative complications (graded on a Clavien-Dindo 5-point scale),16 readmission, and reoperation. Institutional review board approval or exemption was obtained from all respective institutions.
Descriptive statistics were performed using the Microsoft Office Excel 2007 software package. Median and range are presented for continuous variables; categorical variables are presented as a number and percentage.
A technique for morcellation within an insufflated isolation bag was developed by one of the authors (T.S.) for use during laparoendoscopic single-site hysterectomy17 (Video 1, available online at http://links.lww.com/AOG/A543). In this approach, a single-site access port (either the TriPort15 access system or the SILS port) is used at the umbilicus for the procedure. The case proceeds in a standard fashion, and when the uterine specimen is ready for extraction, it is placed in the right upper quadrant of the abdomen. Next, a 50×50-cm isolation bag is folded lengthwise accordion-style beginning at the closed end (Figs. 1 and 2), and air is compressed out of the folded bag. Of note, the isolation bag cost ranges between $2 and $30 per unit at the study sites. Using a laparoscopic grasper, the tightly folded bag is then introduced through the single-site port into the pelvis and laid open. Once the bag is positioned correctly in the pelvis, the specimen is brought down from the upper abdomen and placed into the bag (Fig. 3). The edges around the open end of the bag are grasped and brought to the umbilical incision. The edges of the bag are then exteriorized around the base of the access port and it is resealed (Fig. 4). After this, the abdominal cavity is desufflated, and the isolation bag containing the uterine specimen is insufflated. The laparoscopic camera and morcellator are placed through the access port and the uterine specimen is morcellated under direct vision. All small fragments and fluids are contained within the bag, which is then removed through the umbilical port after sufficient size reduction of the specimen. After a final view of the pelvis to ensure hemostasis, the port is removed and the fascial defect is closed with a delayed absorbable suture. Skin is then closed and dressed in a standard fashion.
This technique has been successfully adapted to multiport laparoscopic and robot-assisted laparoscopic hysterectomy and myomectomy as well. The multiport technique is performed with a 12-mm trocar at the umbilicus and three to four additional 5-mm to 8-mm accessory trocars. After hysterectomy or myomectomy, the uterine specimen is placed into the right upper quadrant and a tightly folded isolation bag inserted into the abdomen at the umbilical site. In these cases, the bag may be inserted either after upsizing to a 15-mm trocar or directly through the skin incision, which can be extended to 2 cm if needed to allow for introduction of the bag without tearing. The isolation bag is then opened and the specimen placed into the bag as before. The bag edges are brought out through the umbilical site, and once the entire rim of the bag is outside of the abdominal cavity, an additional 8–10 cm of bag is circumferentially exteriorized to avoid excess material within the abdomen, which may limit visibility with insufflation. The trocar is then placed again through the orifice of the bag. The abdominal cavity is desufflated and the insufflation tubing connected to the trocar inside the bag at the umbilicus to insufflate the bag under laparoscopic guidance. Once this is accomplished, visual inspection confirms that the inflated bag fully lines the peritoneal cavity with the specimen inside the bag. At this time, a lateral trocar is redirected through the initial skin incision to pierce the isolation bag under laparoscopic guidance, taking care to avoid any bowel, which may be relocated along the lateral abdominal wall and could be in the path of trocar entry. After this, the camera is placed laterally at the lower quadrant site, the insufflation tubing is connected to the lower quadrant trocar, and the umbilical trocar is removed. The morcellator device is then placed at the umbilical location, inside of the inflated bag, and the specimen morcellated under continuous laparoscopic visualization (Fig. 5). After the specimen is removed, a laparoscopic survey of the abdomen and pelvis confirms that no visible specimen pieces are present in the abdomen.
An additional modification involves using a single-site access device along with the multiport approach to facilitate introduction of the isolation bag and removal of the specimen fragments. The authors have used the GelPoint access device and the SILS port through a 2.5- to 3-cm umbilical incision in addition to the lower quadrant trocars noted previously to perform the same procedure. A variety of power morcellators has been used with this technique, including the Rotocut G1, Gynecare Morcellex, and PKS PlasmaSORD.
A total of 73 cases of uterine tissue morcellation within an insufflated isolation bag were performed at the four study institutions. Table 1 summarizes the baseline characteristics of the study population. The median patient age was 43 years (range 30–56 years), median body mass index was 27.9 (range 16.5–56), and the majority were of white race. Approximately two-thirds of patients had undergone prior abdominal surgery.
The operative characteristics of the study population are reported in Table 2. The majority of patients underwent surgery for an indication of leiomyomas or abnormal bleeding. The procedure breakdown was as follows: multiport laparoscopic total hysterectomy (n=12), multiport laparoscopic supracervical hysterectomy (n=12), multiport laparoscopic myomectomy (n=9), single-site laparoscopic total hysterectomy (n=4), single-site laparoscopic supracervical hysterectomy (n=27), single-site laparoscopic myomectomy (n=1), multiport robot-assisted laparoscopic total hysterectomy (n=5), multiport robot-assisted myomectomy (n=2), and single-site robot-assisted laparoscopic total hysterectomy (n=1). Approximately half of the cases included adnexal removal and 18% included adhesiolysis as ancillary procedures.
Key perioperative outcomes included median operative time of 114 minutes (range 32–380 minutes) and median estimated blood loss of 50 mL (range 10–500 mL). Specimen weight ranged from 53 to 1,481 g with a median weight of 257 g. There were no cases of conversion to laparotomy, readmission or reoperation, and 78% of patients were discharged home the same day. One patient experienced an intraoperative complication (asystole during induction of anesthesia, resolved, and case proceeded), and there were four Clavien-Dindo grade 1 postoperative complications (including additional treatments for respiratory infection, ileus, and pain). The isolation bag was successfully used to achieve contained morcellation in all cases. Additionally, the bag was visually inspected at the end of each procedure and was found to be without any additional perforations aside from a single 5-mm puncture site created when using the multiport technique.
Morcellation within an insufflated isolation bag offers gynecologic surgeons an additional option for uterine specimen retrieval, which allows the surgeons to visualize the target anatomy easily, maintain control of the morcellator within the bag, and keep the specimen away from the abdominal viscera. The cases presented in this series highlight the feasibility and reproducibility of this technique. Of note, this is an off-label application of the isolation bag.
Before integrating this technique in the operating room, surgeons will require adequate training. The isolation bag is made of clear plastic drape film and may tear easily during insertion into the abdomen if the skin or trocar site is too small or the bag is folded incorrectly. If this occurs, the tear in the bag will preclude successful insufflation and require replacement with a new bag before morcellation. To overcome bag insertion difficulties, the authors suggest tightly folding the bag in a horizontal fashion, rolling the folded bag if needed to obtain a smaller diameter, and ensuring adequate size of the insertion site. When placing a lateral trocar into the isolation bag with the multiport approach, it is critical to first confirm the location of the bowel along the lateral abdominal wall because it may be displaced along with insufflation of the bag. To avoid slippage of the lateral trocar from its location within the isolation bag, consideration may be given to use of a balloon-tipped trocar (such as Kii balloon-tipped trocars) to enhance stability at this site.
The use of a Lahey bag for containment during removal of large surgical specimens has been previously described during hand-assisted laparoscopic splenectomy in cases of massive splenomegaly.18 Manual morcellation of tissue within a specimen bag under laparoscopic guidance has also been reported as a safe and effective option for specimen retrieval after laparoscopic nephrectomy.19 In vitro studies of porcine renal morcellation have documented some instances of bag perforation when using a power morcellator within a laparoscopic specimen retrieval bag.20–22 In the case of our technique, issues with bag perforation are less likely because the isolation bag is significantly larger than the specimen and once insufflated lies flush against all aspects of the abdominal cavity. The multiport approach does involve an intentional 5-mm puncture of the isolation bag, although it is not known whether this puncture site may serve as an outlet for cellular debris during the morcellation process. Given that the puncture is in a nondependent portion of the isolation bag and is occluded by a trocar, the authors believe it is unlikely for tissue to escape from this site. A study of bag integrity after contained morcellation is an important next step, however. There are many additional aspects of tissue dissemination in the setting of occult malignancy that also require future investigation. For example, microscopic cellular dissemination may occur during a myomectomy or supracervical hysterectomy even when performed through laparotomy. Furthermore, efforts should be made to implement contained morcellation even when not using power morcellation devices; manual tissue morcellation through the vagina or minilaparotomy may also result in dissemination.
Strengths of this study include participation of surgeons from multiple institutions and varying gynecologic disciplines. This, along with the breadth of procedures performed, supports the generalizability of morcellation within an insufflated isolation bag. Weaknesses include the overall small study size, observational nature, and inclusion of only high-volume surgeons. Additionally, the intact status of the bag and lack of tissue dissemination were identified by the surgeon's visual inspection and as such may introduce ascertainment bias. Microscopic tears and leakage from the multiport puncture were not assessed in this study. This is an evolving technique that is in the early stages of development and will benefit from further testing and refinement.
Additional enhancement of minimally invasive specimen retrieval techniques is critical to enhance and optimize perioperative outcomes for women with gynecologic conditions requiring myomectomy or hysterectomy. The intent is not to perform surgery on a malignancy in this manner, but to help protect women who unknowingly have cancer at the time of surgery for presumed benign disease. The benefits of morcellation under direct vision within an insufflated isolation bag include the potential reduction of tissue dissemination while preserving the well-known benefits of minimally invasive gynecologic surgery.
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