Materials and Methods
This is a multicenter prospective cohort study of adult women scheduled to undergo minimally invasive hysterectomy or myomectomy using contained tissue extraction techniques. Participating institutions in the greater Boston, MA, area included the following: Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital, Massachusetts General Hospital, Newton-Wellesley Hospital, and Lahey Hospital and Medical Center.
Thirteen surgeons, all experienced laparoscopic surgeons, enrolled patients in this study. The majority of surgeons are fellowship trained in either minimally invasive gynecologic surgery or reproductive endocrinology and infertility. Institutional review board approval was obtained at all institutions, and the Brigham and Women’s Hospital Institutional Review Board served as the data and safety monitoring board for this study.
The primary outcome measure was leakage of dye or tissue fragments during specimen removal using contained power morcellation. Secondary outcomes included operative time, time required for contained power morcellation, and perioperative complications. Inclusion criteria for enrollment were women 18 years of age or older eligible to undergo laparoscopic or robot-assisted laparoscopic myomectomy or hysterectomy, as determined clinically by the operating surgeon. Exclusion criteria included suspected malignancy, medical illness precluding laparoscopy, inability to give informed consent, allergy to either indigo carmine or methylene blue dye, or morbid obesity. Routine preoperative testing was performed at the discretion of the operating surgeon and included a Papanicolaou smear, endometrial biopsy, imaging with pelvic magnetic resonance imaging or ultrasound, and blood work as indicated.
The following demographic variables were collected: patient age, race, obstetrical history, body mass index (BMI), past surgical history, and indication for surgery. Perioperative variables that were collected included the following: mode of access, type of procedure(s) performed, operative time (defined as time from incision to closure), time for morcellation procedure (defined as time from placing containment bag into abdomen to complete specimen removal), estimated blood loss (defined as surgeon estimate that was recorded in the operative record), specimen weight, number of fibroids removed in cases of myomectomy, type of containment bag used, intact status of the containment bag as visually inspected by surgical team at the end of the procedure, the presence of dye or tissue leakage outside the containment bag, intraoperative complications (defined as visceral, vascular, or nerve injury; estimated blood loss greater than 1000 mL; or serious anesthesia complication), postoperative complications (graded on Clavien-Dindo 5 point scale), length of hospital stay, readmission, reoperation, and pathological results.
Eligible patients were offered enrollment and, if interested, signed informed consent to participate in the study protocol. Patients who declined participation were offered other standard methods of tissue extraction including specimen removal via a colpotomy or minilaparotomy incisions. The contained power morcellation was performed according to a technique that has previously been described.
The laparoscopic or robot-assisted laparoscopic myomectomy or hysterectomy was performed in standard fashion: a 5 or 12 mm port was placed at the umbilicus with additional ports on the abdomen as per surgeon discretion. Following hysterectomy or myomectomy, a tightly rolled containment bag was inserted into the abdomen. Specimen containment bags used for this purpose included the following: EcoSac (Espiner Medical, North Somerset, United Kingdom), 50 × 50 cm isolation bag (3, St Paul, MN), Anchor tissue retrieval system (Anchor Products Co, Addison, IL), and Endocatch (Covidien, Minneapolis, MN).
These containment bag options were chosen from among hospital stock, and the use of a particular bag type was based on surgeon preference. The bag was then opened and the specimen placed into the bag. The bag edges were brought out through the umbilical site, and once the entire rim of the bag was outside the abdominal cavity, a laparoscopic trocar was replaced through the orifice of the bag. Next, the abdominal cavity was desufflated by opening an ancillary port, and the insufflation tubing was connected to the trocar inside the containment bag. After visual inspection to confirm that the inflated bag contained the tissue specimen, a lateral trocar was redirected to pierce the bag. A balloon-tipped trocar (Kii Advanced Fixation, Applied Medical, Irvine, CA) was recommended for this purpose to maintain the trocar position within the bag. The laparoscope was then placed via the lateral port and insufflation tubing connected at this site as well.
At this time, 5 mL of either indigo carmine or methylene blue dye were injected into the bag, and then a power morcellator device (Rotocut G1; Karl Storz, Tuttlingen, Germany) was introduced at the umbilicus. This small volume of blue dye was sufficient to stain the specimen and coat the tissue and associated fluids. The specimen was then morcellated under continuous laparoscopic vision.
At the end of morcellation, the specimen bag was desufflated, the abdominal cavity reinsufflated, and, if using a balloon-tipped trocar, the pneumatic anchor device of the trocar deflated and removed from the bag. This was done in sequence in an effort to avoid the exit of liquids and gas under pressure inside the bag into the abdominal cavity. Following removal of the containment bag, the abdomen and pelvis was carefully examined for any signs of spillage of blue dye, fluid, or tissue.
The integrity of the containment system was also examined by the surgeon. Precautions were outlined such that if a bag tear or leakage was noted at any time prior to or during morcellation, the procedure would be halted and either a new containment bag would be utilized or alternative extraction techniques undertaken.
Given the lack of existing data on the incidence of leakage with contained tissue extraction, a formal power analysis was not performed. The enrollment goal was set at 400 patients in an attempt to comprehensively evaluate this technique, with plans for interim analyses. Specifically, a plan was outlined to halt the study at the time of interim analysis if any complications related to the use of the containment bags were noted or if blue dye leakage was observed in greater than 5% of cases.
Descriptive statistics were calculated using SAS statistical software. Median and range or mean and SD are presented for continuous variables; categorical variables are presented using frequency.
Results
Eighty-nine patients signed informed consent for contained power morcellation of uterine or myoma tissue and were enrolled in this study. Seventy-six patients successfully underwent the contained power morcellation protocol. There were three cases in which the contained power morcellation was not performed as planned because the surgeon found the specimen size too large for either placement of the tissue into a bag or adequate visualization. There were ten cases in which the contained power morcellation was found to be unnecessary and not attempted, most often because of small specimen size or surgeon preference. Following an interim analysis, the decision was made to close the study early because of seven observed instances of fluid or tissue leakage.
Table 1 outlines the patient and procedural characteristics of all cases, separated into completed, unsuccessful, or no contained power morcellation categories. Hysterectomy was performed in 55% of cases; supracervical hysterectomy was performed most often (69% of hysterectomy cases). The most common mode of access was multiport laparoscopy. Among the completed morcellation cases, the mean patient age was 43 years (±8.53). The majority of patients were of white race with a mean BMI of 26.47 (±5.93). Half of the patients were nulliparous and 43% had undergone prior surgery. The predominant indication for surgery was uterine fibroids.
| Characteristics | Completed morcellation (n = 76) | No morcellation (n = 10) | Unsuccessful morcellation (n = 3) |
|---|---|---|---|
| Procedure, n, % | |||
| Hysterectomy | 42 (55.3%) | 6 (60.0%) | 1 (33.3%) |
| Myomectomy | 34 (44.7%) | 4 (40.0%) | 2 (66.7%) |
| Subtype of hysterectomy, n, % a | |||
| Total | 13 (31.0%) | 3 (50.0%) | 1 (100.0%) |
| Supracervical | 29 (69.0%) | 2 (33.3%) | 0 (0%) |
| Radical | 0 (0%) | 1 (16.7%) | 0 (0%) |
| Approach, n, % | |||
| Laparoscopic multiport | 66 (86.8%) | 7 (70.0%) | 1 (33.3%) |
| Robotic, multiport | 10 (13.2%) | 3 (30.0%) | 2 (66.7%) |
| Additional procedure, n, % | |||
| No | 26 (34.2%) | 3 (30.0%) | 2 (66.7%) |
| Yes | 50 (65.8%) | 7 (70.0%) | 1 (33.3%) |
| Age | |||
| Mean (SD) | 43.16 (8.53) | 44.50 (8.06) | 40.67 (6.66) |
| Race, n, % | |||
| White | 50 (65.8%) | 8 (80.0%) | 2 (66.7%) |
| Black | 12 (15.8%) | 1 (10.0%) | 0 (0%) |
| Hispanic/Latino | 6 (7.9%) | 0 (0%) | 0 (0%) |
| Asian/Pacific Islander | 6 (7.9%) | 1 (10.0%) | 1 (33.3%) |
| Other | 1 (1.3%) | 0 (0%) | 0 (0%) |
| Declined | 1 (1.3%) | 0 (0%) | 0 (0%) |
| BMI | |||
| Mean (SD) | 26.47 (5.93) | 25.59 (8.54) | 27.80 (5.56) |
| Parity, n, % | |||
| Nulliparous | 38 (50.0%) | 5 (50.0%) | 2 (66.7%) |
| 1-2 live births | 30 (39.5%) | 5 (50.0%) | 1 (33.3%) |
| > 2 live births | 8 (10.5%) | 0 (0%) | 0 (0%) |
| Prior abdominal surgery, n, % | |||
| None | 43 (56.6%) | 5 (50.0%) | 1 (33.3%) |
| Laparotomy | 16 (21.1%) | 1 (10.0%) | 0 (0%) |
| Laparoscopy | 11 (14.5%) | 3 (30.0%) | 1 (33.3%) |
| Both | 6 (7.9%) | 1 (10.0%) | 1 (33.3%) |
| Indication for surgery b | |||
| Pain/endometriosis | 14 (18.4%) | 2 (20.0%) | 0 (0%) |
| Abnormal bleeding | 23 (30.3%) | 1 (10.0%) | 0 (0%) |
| Fibroids | 59 (77.6%) | 8 (80.0%) | 3 (100%) |
| Pelvic organ prolapse | 6 (7.9%) | 2 (20.0%) | 0 (0%) |
| Other indication | 4 (5.3%) | 0 (0%) | 0 (0%) |
a Among those who had a hysterectomy
Perioperative outcomes for the 76 patients who completed the contained power morcellation protocol are listed in Table 2 . Mean operative time was 174.9 minutes (±84.9), whereas the mean time for the contained morcellation procedure was 30.2 minutes (±22.4). Mean estimated blood loss was 164.7 mL (±435.1). There was one intraoperative complication, which was a case with an estimated blood loss of 3600 mL and intraoperative conversion to open radical hysterectomy because of the size of the uterine fibroid and the degree of anatomic distortion. The mean hysterectomy specimen weight was 480.1 g (±359.1), and the mean myomectomy specimen weight was 239.1 g (±229.7), with 26% of myomectomies involving removal of more than 5 fibroids.
| Variable | Completed morcellation |
|---|---|
| OR time, incision to close (minutes) | |
| Mean (SD) | 174.9 (84.94) |
| Time for morcellation procedure, bag in to bag out (minutes) | |
| Mean (SD) | 30.15 (22.38) |
| Intraoperative complications, n, % | |
| No | 75 (98.7%) |
| Yes | 1 (1.3%) |
| EBL > 1000 mL | |
| No | 75 (98.7%) |
| Yes | 1 (1.3%) |
| EBL, mL | |
| Mean (SD) | 164.7 (435.1) |
| Hysterectomy specimen weight by pathology, g | |
| Mean (SD) a | 480.1 (359.1) |
| Myomectomy specimen weight by pathology, g b | |
| Mean (SD) | 239.1 (229.7) |
| Postoperative Clavien-Dindo complication rating (1-5) | |
| 0 | 69 (90.8%) |
| 1 | 2 (2.6%) |
| 2 | 5 (6.6%) |
| Length of stay, d | |
| 0 | 56 (73.7%) |
| 1 | 17 (22.4%) |
| 2 | 3 (3.9%) |
| Pathology findings c | |
| Fibroids | 64 (84.2%) |
| Adenomyosis | 17 (22.4%) |
| Endometriosis | 2 (2.6%) |
| Ovarian or Fallopian tube cyst | 3 (3.9%) |
| Other benign finding | 10 (13.2%) |
| Cancer | 0 (0.0%) |
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