Abstract
Abstract
Background:
To compare the clinical results of two types of laparoendoscopic single-site surgery (LESS) laparoscopic hysterectomy (LH): LH with some vaginal component [LH(a)] versus laparoscopically assisted vaginal hysterectomy (LAVH).
Subjects and Methods:
This is a retrospective comparative study. A single surgeon performed 50 LESS-LAVH procedures consecutively between March 2009 and October 2009 and 50 LESS-LH(a) procedures consecutively between January 2011 and July 2011.
Results:
Most LESS-LH(a)s/LAVH procedures were successful. Of 50 LESS-LH(a) procedures, 2 were converted to LESS-LAVH. Of 50 LESS-LAVHs, 1 required additional ports. The LESS-LH(a) group had a shorter operative time and less postoperative pain compared with the LESS-LAVH group. Operative complications were not significantly different between the groups.
Conclusions:
LESS-LH(a) and LESS-LAVH are both feasible and safe methods, with similar surgical outcomes. In terms of operative time and postoperative pain, LESS-LH(a) is superior to LESS-LAVH.
Introduction
L
Technologic advances in endoscopic instrumentation and optics have allowed the development of an even less invasive procedure than conventional laparoscopy using multiple ports: laparoendoscopic single-site surgery (LESS), also known as single-port access laparoscopy. Currently, LESS-TLH/LH(a) and LESS-LAVH are all feasible, with comparable perioperative outcomes when compared with conventional laparoscopy.5,6 However, there is no study comparing the surgical outcomes between these procedures. Therefore, the current study was performed to compare the surgical outcomes between LESS-LH(a) and LESS-LAVH in order to determine the advantages and disadvantages of these surgical methods.
Subjects and Methods
Patients
This study is a comparative study of 50 LESS-LH(a) procedures and 50 LESS-LAVH procedures performed by a single surgeon at the Samsung Medical Center in Seoul, Republic of Korea. Between March 2009 and October 2009, an experienced surgeon (T.-J.K.) performed LESS-LAVH on consecutive patients for benign gynecologic diseases with the assistance of two residents. Subsequently, the same surgeon performed LESS-LH(a) on 50 consecutive patients with the same gynecologic indications between January 2011 and July 2011. During each study period, none of the patients had elective, conventional TLH/LH(a)/LAVH; all patients were treated with either LESS-LH(a) or LESS-LAVH. The data for all patients were collected prospectively after approval by the Institutional Review Board at the Samsung Medical Center.
For both LESS-LH(a) and LESS-LAVH, inclusion criteria included a planned hysterectomy for benign gynecologic disease, no evidence of gynecologic malignancy, and appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification I–II). Exclusion criteria included a uterine size >18 gestational weeks by pelvic examination, recent diagnosis of cancer, or inability to understand and provide written informed consent. Operative time was defined as the time from the umbilical skin incision to completion of skin closure. The estimated blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference in the total weight of gauzes before and after surgery. Hemoglobin change was defined as the difference between the hemoglobin level preoperatively and that on postoperative Day 1. Failure of operation was defined as the use of additional ports, conversion to laparotomy, or conversion to LESS-LAVH in cases of LESS-LH(a). Postoperative hospital stay was defined as the day from operation to discharge. Operative complications were defined as all intraoperative and postoperative complications arising within 90 days of surgery, including any major vessel, nerve, gastrointestinal, and urinary tract injury. Postoperative pain intensity was rated with patients using a visual analog scale at 12, 24, and 36 hours after surgery. The scale was presented as a 10-cm line with anchored verbal descriptors using “no pain” and “worst imaginable pain.”
Surgical techniques
All patients underwent the same standard preparation prior to surgery, including prophylactic antibiotics 30 minutes before the procedure. They were placed in the dorsal lithotomy position, and general anesthesia with endotracheal intubation was achieved. After uterine sounding and cervical dilation, a uterine manipulator was fixed onto the cervix to effectively manipulate the uterus: an RUMI uterine manipulator with a Koh Colpotomizer™ system (Cooper Surgical, Trumbull, CT) in cases of LESS-LH(a) and a Hulka uterine manipulator (Allegiance Healthcare, McGraw Park, IL) in cases of LESS-LAVH were used. At the start of surgery, a 2.0–2.5-cm vertical incision was made within the umbilicus via an open Hasson approach. The LESS port was inserted into the wound opening transumbilically. The LESS port utilized was a homemade port (noncommercial port system) or a SILS™ port (Covidien, Norwalk, CT). A homemade port, which was previously described, 7 consists of a small wound retractor (Alexis; Applied Medical, Rancho Santa Margarita, CA) and a surgical glove with three cannulas. The multiple fingers of the glove functioned as a multichannel for laparoscopic instruments and a scope. The SILS port consists of a blue, flexible, soft-foam port with access channels for three cannulas. To perform laparoscopic procedures, a 5-mm, 30° or 0°, rigid laparoscope, conventional laparoscopic instruments such as graspers and dissectors, and electrosurgical instruments such as monopolar or bipolar devices (bipolar Maryland dissector; Aesculap, Tuttlingen, Germany) and the 5-mm blunt tip LigaSure™ (Valleylab, Covidien, Boulder, CO) were used. Also, an articulating instrument (Roticulator™ shears, dissector, and grasper; Covidien, Mansfield, MA) was used to avoid clashing of the instruments and to optimize the range of motion.
LESS-LH(a)
After a laparoscope was introduced, the entire abdominal cavity was carefully inspected. Either the infundibulopelvic ligament or utero-ovarian ligament was secured and divided by the LigaSure, depending on whether the ovary was preserved or not. To expose the lateral side of the uterus, the uterine body was retracted medially with a laparoscopic claw forceps or a myoma screw, then the round ligament was transected, and the anterior and posterior leaves of the broad ligament were separated. Next, the vesicouterine peritoneal fold was identified, and the bladder was mobilized by blunt and sharp dissection using the LigaSure or a bipolar dissector until the anterior vagina was identified. The uterine vessels were skeletonized, sealed, and transected using the LigaSure or a bipolar device, while the uterus was mobilized to the opposite side with the uterine manipulator and a claw forceps (or a myoma screw). The cardinal and uterosacral ligaments were then transected. The procedure was then repeated on the opposite side. After the balloon of a Colpo-Pneumo Occluder™ (Cooper Surgical) was insufflated with air, a circumferential colpotomy was performed completely with an articulating monopolar device (Roticulator) over the Colpotomizer cup, and then the specimen was removed via the vagina. Vaginal uterine morcellation was performed as necessary to facilitate vaginal removal of the large uterus. The vaginal cuff was vaginally sutured with a running suture. After bleeding was controlled, the LESS port was removed, and fascia and subcutaneous tissue were approximated and closed layer-by-layer with delayed absorbable suture material. To close the skin, we used skin adhesive (Dermabond®; Ethicon, Somerville, NJ), which was convenient for the patient.
LESS-LAVH
Patient preparation and the technique of placing the LESS port in LESS-LAVH were identical to those in LESS-LH(a). After the entire abdominal cavity was carefully inspected with a laparoscope, LESS-LAVH was performed as follows. 7 The ovarian ligaments, round ligaments, and broad ligaments were severed by a 45-mm Endo GIA™ (a single-use loading unit with titanium staples; Covidien) at once. If the adnexal collaterals were not dissected because of distorted uterine anatomy, the adnexal collaterals were secured by monopolar and bipolar devices. When the adnexal collaterals were dissected bilaterally and the bleeding was controlled, the vaginal procedure commenced. For the vaginal procedures, the anterior and posterior aspects and the cervix were grasped together with two tenacula, and a circumferential incision was made at the junction of the vagina and the cervix. After a vesicovaginal space was made by using both blunt and sharp dissection, the bladder was displaced from the region of dissection by inserting a right-angle retractor into the vesicovaginal space. The rectum was displaced from the dissected region with a right-angle retractor after the posterior cul-de-sac was exposed by a culdotomy. The uterosacral ligaments and uterine arteries were clamped, cut, and ligated. After these procedures, the uterus was completely isolated and removed by wedge resection, coring, and morcellation. After completion of hemostasis, closure of the peritoneum was performed along with closure of the vaginal vault and the insertion of a Foley catheter. The abdominal cavity was then insufflated with CO2 gas and laparoscopically washed with normal saline solution, and finally the umbilical incision was closed in the same way as for LESS-LH(a).
Postoperative management
According to the postoperative pain management protocol in our institution, intravenous patient-controlled analgesia was used in all patients from 30 minutes before the end of surgery to 48 hours after surgery. After surgery, parenteral analgesia (30 mg of ketorolac tromethamine) was administered on demand. Oral nonsteroidal anti-inflammatory drugs (8 mg of zaltoprofen) were given regularly three times daily, generally beginning on postoperative Day 2 when a soft diet was permitted. On postoperative Day 1, we measured serum hemoglobin levels.
Statistics
Statistical analyses were performed using SPSS software (version 15.0; SPSS, Inc., Chicago, IL). We did not exclude the data involving failed cases for the intent-to-treat analysis. A chi-squared test or Fisher's exact test was used to compare nominal scales, such as the use of an additional port and perioperative complications between groups, after the normality of the data was checked. A Student's t test or Mann–Whitney test was used for analysis of differences depending on the distribution of continuous data. Statistical significance was set at P<.05, and all reported P values are two-sided.
Results
Of 100 patients who were initially planned to undergo LESS-LH(a) (n=50) and LESS-LAVH (n=50), none of the patients was excluded for data analysis. The baseline characteristics of the study populations are summarized in Table 1. There was no statistically significant difference in age or body mass index between the two groups. Preoperative characteristics, including vaginal delivery history, abdominal surgical history, existence of comorbidities, and uterine size measured by ultrasonography, were comparable between the groups. The most common surgical indication in both groups was uterine myoma and/or adenomyosis. Operative procedures performed and adhesiolysis were also not significantly different between the groups.
Comorbidity included diabetes, hypertension, heart disease, and stroke.
The diameter of the uterus was measured by transvaginal ultrasonography before surgery.
LAVH, laparoscopically assisted vaginal hysterectomy; LESS, laparoendoscopic single-site surgery; LH(a), laparoscopic hysterectomy with some vaginal component.
The surgical results are compared between the two groups in Table 2. Most LESS-LH(a)/LAVH procedures were successful, but 2 cases in the LESS-LH(a) group and 1 case in the LESS-LAVH group failed. In the LESS-LH(a) group, none of the patients needed an additional port; however, 2 patients with large lower uterine myomas and dense adhesions in the posterior cul-de-sac area were converted to LESS-LAVH to complete the procedure. In the LESS-LAVH group, one additional port was needed for 1 case because of large uterine size (1149 g). No conversion to laparotomy occurred in either group. The uterine weight, estimated blood loss, serum hemoglobin change, and postoperative hospital stay were similar between the two groups. However, the mean operative time for LESS-LH(a) was significantly shorter than that for LESS-LAVH (91.2 minutes versus 107.1 minutes; P=.013). The number of parenteral analgesics given and the postoperative visual analog scale pain score at 12 hours were comparable between the two groups. However, the pain scores at 24 and 36 hours were significantly lower in the LESS-LH(a) group than in the LESS-LAVH group (P=.011 and P=.001, respectively).
Postoperative pain score was measured by visual analog scale.
Vaginal vault problem includes abscess formation, bleeding, and dehiscence.
Urinary tract problem includes bladder laceration and vesicovaginal fistula.
With regard to perioperative complications, there were 3 cases in the LESS-LH(a) group and 2 cases in LESS-LAVH group. In the LESS-LH(a) group, 2 patients (4%) had a vaginal vault problem, and 1 patient (2%) had a urinary tract problem. There was 1 case of vaginal vault dehiscence, which developed during sexual coitus 2 months after surgery and was repaired vaginally without sequelae, 1 case of vaginal vault bleeding, which occurred 10 days after surgery and was managed with vaginal packing, and 1 case of intraoperative bladder injury, which developed during laparoscopic adhesiolysis and was immediately repaired laparoscopically. In the LESS-LAVH group, 1 patient (2%) had a vaginal vault problem (abscess), and another patient had a urinary tract problem (vesicovaginal fistula, which developed 4 weeks postoperatively, required laparoscopic surgical repair, and resolved without sequelae). Overall, operative complications were not significantly different between the groups.
Discussion
In the present series, we compared 50 cases of LESS-LH(a) and 50 cases of LESS-LAVH that were performed by a single surgeon without case selection. Our findings confirmed that LESS-LH(a) and LESS-LAVH are both feasible and safe treatment options with similar surgical outcomes for women with benign gynecologic diseases. We also found that each procedure has its merits and faults. Compared with LESS-LAVH, LESS-LH(a) is associated with shorter operative time and less postoperative pain. In contrast, LESS-LAVH was feasible in cases where LESS-LH(a) seemed to be impossible because of large lower uterine myomas or severe cul-de-sac obliteration. Large myomas located in the lower uterine body or cervix made instrumental approaches through the single transumbilical port difficult. On account of the complete cul-de-sac obliteration, it was not easy to dissect laparoscopically because of lower grasping power of an articulating instrument. The current study is the first study to assess and compare individual LESS LHs with prospective data collection.
Since its initial description, 8 several LH techniques have been described with variation in the proportion of the procedures performed laparoscopically versus vaginally. To standardize the terminology of this procedure, in 1995, Nezhat et al. 9 and Richardson et al. 10 proposed their classification systems, which included seven steps and five stages, respectively. Also, in 2000, the American Association of Gynecologic Laparoscopists published its classification system of five types. 11 According to these classification systems, LAVH corresponds to step 2/stage 2/type I, and LH(a) corresponds to step 6/stage 5/type IV. In the recent Cochrane review about the surgical approach to hysterectomy, 2 LH was simply divided into LAVH, LH(a), and TLH in order to improve communication between clinicians and researchers. In the term “LH(a),” “a” means uterine artery. The term “TLH” can be used only if the entire operation including suturing of the vaginal vault is performed laparoscopically and there is no vaginal component except for the removal of the uterus. Considering our experiences, in which laparoscopic vault suturing in LESS-TLH required a high degree of skill, we thought that LESS-LH(a) was a more appropriate choice than LESS-TLH.
In the current study, the operative time in the LESS-LH(a) group was significantly shorter than that of the LESS-LAVH group. This finding was perhaps due to the use of LigaSure in the LESS-LH(a) group; securing vascular pedicles with the LigaSure was faster than conventional clamping and suture ligation of vascular pedicles. This concurs with the results of randomized studies, including one study that reported reduction of around 50% in the mean operative time for hemorrhoidectomy with the use of LigaSure12,13 as well as a randomized study of vaginal hysterectomy, 14 in which LigaSure led to a significant reduction in the operative time from 66 minutes to 57 minutes (P=.004).
Pain after surgery is a critical issue because of its connection to postoperative analgesic supplement usage, recovery, hospital stay, and return to normal activities. Our study demonstrates that the postoperative pain at 24 and 36 hours after surgery was decreased significantly in LESS-LH(a) compared with LESS-LAVH. Herein, several possible explanations can be hypothesized to explain our data. First, unlike LESS-LH(a), LESS-LAVH frequently requires applying a vigorous downward traction on the uterus. Second, we used the LigaSure to coagulate and dissect tissues during LESS-LH(a), whereas the vaginal phase of LESS-LAVH was performed using clamps, scissors, and tying knots, according to traditional vaginal techniques. Regarding this latter possible explanation, some studies have consistently shown how the implementation of the LigaSure in vaginal surgery resulted in a significant reduction of postoperative pain.14–16
According to Hur et al.17,18 and Uccella et al., 19 TLH is associated with an increased risk of vaginal vault problems compared with other modes of total hysterectomy. Actually, we also encountered 1 case of vaginal vault dehiscence in the LESS-LH(a) group. Although we sutured the vaginal cuff by the vaginal route (not by the laparoscopic route) in that case, thermal necrosis might be encountered while separating the uterus from the vagina. Therefore, surgeons should be careful of thermal necrosis when they cut the vagina laparoscopically.
In the present study, there were 2 cases of conversion to LESS-LAVH from LESS-LH(a). Considering that LESS-LH(a) requires much more laparoscopic skill than LESS-LAVH, it could be more difficult to perform LESS-LH(a) than LESS-LAVH. Although the choice of the route of hysterectomy depends on the patient's anatomy and the surgeon's preference, LESS-LH(a)/LAVH has its advantages and disadvantages based on our study's findings and experiences. Compared with LESS-LH(a), LESS-LAVH has the advantage of a back-up approach in cases where LESS-LH(a) seemed to be impossible because of large lower uterine myomas and severe pelvic adhesions around the cul-de-sac, but it has the disadvantage of longer operative time. In contrast to this, LESS-LH(a) has the advantages of less postoperative pain and shorter operative time, but it has the disadvantage of the use of expensive laparoscopic instruments such as the LigaSure system.
In this study, there was a change of the operative device from Endo GIA to LigaSure in LESS-LH(a). We used Endo-GIA in LESS-LAVH because Endo GIA allowed the round ligament, broad ligament, and ovarian ligament (or infundibulopelvic ligament) to be severed simultaneously and readily, and the bladder peritoneum was not dissected during the laparoscopic phase of LAVH. In contrast, we used LigaSure instead of Endo GIA in LESS-LH(a) because the LH(a) technique included laparoscopic dissection of the vesicouterine peritoneal fold and laparoscopic transection of the uterine artery.
Laparoscopic suturing is widely considered one of the most difficult and time-consuming tasks performed during laparoscopic surgery. The main reason for this is the need to tie knots in a confined space with limited visualization. These limitations are even more pronounced in LESS. Therefore, to avoid the technical difficulty that accompanies intracorporeal suturing of the vaginal cuff during LESS hysterectomy, we used a transvaginal cuff suture in all cases. However, if surgeons were familiar with laparoscopic suturing under the LESS setting, LESS-TLH may be the best choice for LH.
The limitations of this study are as follows. First, all procedures were performed by one surgeon, and the results may not be applicable to other surgeons. The findings remain to be validated through a randomized protocol, if possible, with many surgeons at multiple institutions. Second, the laparoscopic devices were not the same in all intervention. We used LigaSure in LESS-LH(a), whereas we used conventional suture ligation in LESS-LAVH. This may lead to a bias. The use of LigaSure may lead to the reduction of the operative time and postoperative pain. Also, we used two different LESS ports: a homemade port and SILS (a commercial LESS port). When we started LESS, there was no available commercial LESS port in Korea. Consequently, most procedures were performed using a homemade port, not a commercial LESS port. Therefore, our results may not be directly relevant to other surgeons using different devices, and the reproducibility may be questionable. Third, our study patients were enrolled from two cohorts of consecutive patients with a time gap. These factors may weaken our results. We performed a randomized controlled trial of LESS-LAVH compared with conventional LAVH during the time gap and reported that LESS-LAVH was superior to conventional LAVH in terms of cosmetic satisfaction assessed at 1, 4, and 24 weeks after surgery (P<.01). 20
In conclusion, our study suggests that both LESS-LH(a) and LESS-LAVH are a feasible and safe approaches with similar surgical outcomes to manage benign gynecologic disease. LESS-LH(a) using LigaSure is associated with shorter operative time and shorter postoperative time, compared with LESS-LAVH. Multicenter prospective randomized clinical trials are warranted to validate the results of this study. Furthermore, a more detailed analysis of complications with a large sample size will be necessary.
Footnotes
Acknowledgments
This study was supported by the Samsung Medical Center Clinical Research Development Program (grant CRS-110-02-1).
Disclosure Statement
No competing financial interests exist.
