Laparoendoscopic Single-Site Surgery in Gynecologic Oncology

Postoperative Pain

Postoperative pain after gynecologic surgical procedures varies and is affected by both patient and technical factors, both modifiable and unmodifiable. Given that LESS uses only one small skin incision, in theory it should further minimize incision-related pain compared with MPL. The hypothesis that LESS may result in reduced postoperative pain has been explored in several comparison series, as well as in three randomized controlled trials.

In the first randomized study, 100 women underwent laparoscopically assisted vaginal hysterectomy performed with either LESS or MPL. A single team of a lead surgeon and an assistant surgeon performed every procedure. MPL was accomplished with a 12-mm umbilical port and three 5-mm ports (suprapubic and right and left lower abdomen). A single 1.5-cm intraumbilical skin incision and a 1.5- to 2-cm fascial incision were used for LESS. Two women in the LESS group required placement of an additional port (suprapubic) to assist with adhesiolysis, but no cases required conversion to laparotomy. No differences in operative time, estimated blood loss, length of stay, or complication rate were noted between the groups. Abdominal and shoulder pain were independently assessed by using a visual analog scale (VAS) at 12, 24, and 48 hours postoperatively. This prolonged evaluation was possible because of the culture of longer hospitalization (length of stay >3 days for both groups) in the country where the study was performed (Taiwan). The VAS consisted of a nongraduated 10-cm line ranging from “no pain” to “pain as bad as it could be.” Pain medication (meperidine and/or tenoxicam) was administered when requested, and accumulated doses were summated at 48 hours after operation. Abdominal pain scores at 24 and 48 hours after operation were significantly lower in women who underwent LESS compared with MPL (3.64 ± 2.75 vs. 5.08 ± 2.76 at 24 hours, P = .011; and 1.94 ± 2.31 vs. 2.84 ± 2.07 at 48 hours, P = .043). Accumulated doses of pain medication were significantly lower in women who underwent LESS compared with MPL (74.4 ± 24.25 vs. 104.8 ± 57.08 mg of meperidine, P = .001; and 16 ± 13.4 vs. 33.6 ± 28.7 mg of tenoxicam, P < .001). Neither postoperative pain 12 hours after operation nor shoulder pain at any time point differed between surgical approaches. Although women were randomized to either LESS or MPL for completion of the procedures, they and the investigators collecting data, including pain scores, were not prevented from identifying the number of incisions present postoperatively. This lack of blinding with respect to surgical approach could conceivably have influenced the results. Details concerning anesthesia and intraoperative administration of pain medication were not reported and may also have affected postoperative pain measures independent of surgical approach.

In the second randomized study, 60 women underwent adnexal surgery with either LESS or MPL. MPL was accomplished with a 10-mm umbilical port and three 5-mm lower abdominal ports. A single 1.5- to 2-cm open umbilical incision was used for LESS. The anesthesiology protocol, including administration of pain medications intraoperatively, was strictly standardized. Of note, no preoperative or postoperative local anesthesia was used at skin incisions. No intraoperative complications or conversions to laparotomy occurred in either group, and operative times were similar. Postoperative pain was evaluated at rest and after Valsalva maneuver at 20 minutes and 2, 4, and 8 hours after operation by using a similar VAS. Investigators collecting these postoperative data were blinded with regard to each patient’s surgical approach. Women in the LESS group reported reduced pain at each interval, both at rest and with Valsalva maneuver. The difference was greatest and statistically significant at 4 hours postoperatively ( P = .004 and P = .01 at rest and after Valsalva maneuver, respectively). Women in the LESS group also used less pain medication (8 vs. 21 doses of paracetamol 1000 mg orally or intravenously, P = .001). No difference in pain was reported between surgical approaches at the time of discharge (mean hospital stay of 1.3 vs. 1.4 days for LESS and MPL, respectively). Thus, although the measured differences in postoperative pain and analgesia use achieved statistical significance, their clinical significance may be debated.

A third randomized study compared postoperative pain after adnexal surgery for benign disease via LESS versus MPL in 40 women. Of potential significance in this study was a standardized protocol of preoperative analgesia. One hour before operation, all women received 1.5 g of paracetamol, 100 mg of diclofenac, and 10 mg of oxycodone orally. Furthermore, 0.5% bupivacaine hydrochloride was injected subcutaneously immediately before each skin incision. Both overall postoperative pain and shoulder-specific postoperative pain were assessed at 6 and 24 hours after operation by using a 10-point scale. Women in both groups reported similar levels of pain at 6 and 24 hours after operation (2.2 vs. 1.9, P = .62 at 6 hours; and 3.0 vs. 2.5, P = .35 at 24 hours for LESS vs. MPL, respectively). Furthermore, no difference in postoperative analgesia needs was noted. The impact of the rigorous preoperative analgesia protocol as well as local anesthetic injections on these results is unclear but may have contributed to improved pain measures across surgical approaches. It is curious to note that women who underwent LESS reported significantly more shoulder pain than women in the MPL group (2.4 vs. 0.6, P = .01 at 6 hours; and 3.1 vs. 1.4, P = .03 at 24 hours, respectively). The authors hypothesized that increased shoulder pain in the LESS group may be explained by the longer operative time of 42 minutes compared with 31 minutes for MPL. Overall, currently available evidence suggests postoperative pain and use of analgesia may be reduced after LESS compared with MPL, but the clinical significance of this difference may be small.

Incisional Morbidity

Use of only one incision, and creation of that incision by using an open technique, may be theorized to result in less morbidity related to incisions and port placement, such as vascular, gastrointestinal, or nerve injury. These injuries may be highly clinically significant when they occur but are fortunately relatively rare with MPL. Their potential minimization with LESS, although desirable, would be challenging to demonstrate given statistical sample size requirements. As anticipated, no study to date has demonstrated a statistically significant reduction of incisional morbidity with LESS as compared with MPL.

Paradoxically, one concern regarding LESS is that use of a larger umbilical incision may result in more postoperative hernias in this location. Previous studies have demonstrated a correlation between trocar size and risk of incisional hernia, lending validity to this concern. A recent meta-analysis of 19 randomized controlled trials, including 1705 patients, comparing LESS and MPL for completion of either cholecystectomy or appendectomy suggested a slightly higher incidence of incisional hernia after LESS. Trocar-site hernia was noted in 2.2% of patients in the LESS group, compared with 0.7% in the MPL group (odds ratio [OR], 2.26; 95% confidence interval [CI], 1.00–5.08; P = .05). Secondary analysis of 14 trials considered to be of “high or acceptable quality” demonstrated an OR of 2.88 (95% CI, 1.09–7.61; P = .03). The authors acknowledge a number of limitations of their meta-analysis. Detailed information regarding fascial closure method and follow-up assessment was not reported in several studies. Incisional hernia incidence was a primary outcome in only 2 of the 19 studies. In addition, 1 of the 19 reports contributed a relative weight of 20.1% of the combined data. In this industry-sponsored study in which participating surgeons had limited experience with LESS, rate of trocar site hernia was 10% for LESS and 1.6% for MPL. If the results of this study are excluded in sensitivity analysis, the higher rate of incisional hernia with LESS is not maintained (OR, 1.85; 95% CI, 0.58–5.86; P = .30). Regardless, the recommendation for “meticulous closure of the fascia” during LESS is reasonable.

Results from a retrospective cohort analysis of 211 women who underwent LESS for a variety of gynecologic indications at four institutions are reassuring. Fascial closure was performed in either a running fashion or with interrupted figure-of-eight sutures by using a delayed absorbable 0-Vicryl suture (Ethicon, Somerville, New Jersey). After a median follow-up of 16 months, umbilical hernias occurred in 2.4% of patients (n = 5), between 3.5 and 18 months postoperatively. Most had additional risk factors, such as obesity or connective tissue disorders. In women lacking these risk factors, the rate of umbilical hernia was only 0.5%. These rates are comparable to those reported for MPL.

Cosmesis

The cosmetic result of an LESS incision is dependent on the preoperative size and appearance of each particular patient’s umbilicus and the surgeon’s ability to “hide” the incision. Although it seems logical that a single incision hidden within the umbilicus would provide cosmetic improvement compared with the use of three to five abdominal incisions in MPL, studies examining this question in gynecologic surgery are scarce.

Satisfaction with cosmesis after LESS or MPL for hysterectomy was the primary outcome of a randomized controlled trial including 40 women. The Body Image Questionnaire (BIQ), a validated tool for assessment of body image and cosmetic satisfaction, was completed before operation and at 1, 4, and 24 weeks after operation. A 12-mm umbilical port and either two or three 5-mm ports in the lower abdomen were used for MPL. Of note, there were no significant differences between the two groups with regard to clinical demographic data, operative times, uterine weights, perioperative complication rate, postoperative hospital stay, postoperative pain scores, or analgesic use. Women in the LESS group reported significantly higher cosmetic satisfaction compared with those in the MPL group at 1, 4, and 24 weeks after operation ( P < .01).

In a survey study, 250 women were shown a series of photos of an unscarred female abdomen. Each photo was marked with typical incision lengths and locations for gynecologic procedures performed using LESS, MPL, or robotic-assisted laparoscopy (RAL). When asked to rank the incisions in order of preference, the first choice was MPL, LESS, or RAL 56.4%, 41.1%, and 2.5% of the time, respectively. Notably, the MPL photo showed a 5-mm incision at the umbilicus compared with a 25-mm incision for LESS. Whereas the locations of all three additional MPL incisions were drawn below the waistline, this is often not practical in reality.

Incisional Utility

Although not captured in published reports, we, as well as many other gynecologic surgeons who are currently performing LESS, find the longer incision at the umbilicus used in LESS to be useful in a number of situations. Most incisions for MPL are meant to minimize fascial disruption. Removal of even normal-size adnexa, as in the case of risk-reducing BSO, let alone a substantial adnexal mass, is generally not possible without significant expansion of one of the incisions or use of a colpotomy. After extension of an incision and mass extraction, performance of additionally indicated procedures may be challenging owing to difficulty with maintenance of pneumoperitoneum. Alternatively, if an adnexal mass removed by using LESS is found to be malignant at intraoperative pathology evaluation, pneumoperitoneum can be easily reestablished for laparoscopic staging. Furthermore, the LESS incision can be used in a fashion similar to “mini-laparotomy” for extracorporeal performance of procedures such as partial omentectomy, repair of small bowel enterotomy, or even performance of small bowel resection with anastomosis. After these, replacement of the LESS access device can facilitate further laparoscopic work when indicated. Finally, the central location of the typical umbilical LESS incision provides equally useful access to both pelvic and upper abdominal regions. This facilitates proper thorough intraperitoneal evaluation during comprehensive surgical staging of gynecologic malignancies while minimizing potential incisional morbidity.

Maintenance of Pneumoperitoneum

Pneumoperitoneum is essential for performance of laparoscopy and requires an airtight seal between laparoscopic ports and the body wall. Individual ports traditionally allow passage of only one instrument at a time. To enable LESS, passage of multiple instruments must occur through one skin incision. A number of industry-developed access devices are available that overcome this challenge. Although the devices commonly available in the United States are noted here, their inclusion should not be perceived as an endorsement. Each design has strengths as well as limitations, which may or may not be pertinent depending on the needs of the surgeon and the particular case.

The Triport+, Triport 15, and Quadport+ (Olympus America, Center Valley, Pennsylvania) are single-port access devices consisting of two flexible rings with an intervening plastic sleeve ( Fig. 24.1 ). An introducer is used to place one ring through a small incision into the peritoneal cavity. The second ring is pushed flush to the skin of the abdomen as the intervening plastic sleeve is pulled tight. The device can span a body wall incision up to 10 cm in length. An airtight, removable cap is then placed onto the outer ring. The design with respect to the cap differs in terms of number and size (5–15 mm) of available port openings. The openings are flexible and allow placement of either straight or curved instruments. There are also tubes for insufflation and gas evacuation.

The GelPOINT Advanced Access Platform (Applied Medical, Rancho Santa Margarita, California) consists of three parts: the Alexis Wound Retractor, a GelSeal cap, and several low-profile sleeves ( Fig. 24.2 ). The wound retractor consists of two flexible plastic rings with an intervening sleeve. One ring is inserted through an incision 1.5 to 7 cm in diameter. The other ring is pulled tight to the skin by reducing the length of the intervening plastic sleeve. Once the apparatus is tightly in place on the abdominal wall, a removable GelSeal cap is applied. Valves for insufflation and evacuation of gas are present. Three 5- to 10-mm and one 12-mm self-retaining low-profile sleeves (ports) are included and can be placed through the gel in any desirable configuration. The GelPOINT Mini Access Platform (Applied Medical) is a similar but smaller product, accommodating incisions with diameters of 1.5 to 3 cm.

The SILS Port (Medtronic, Minneapolis, Minnesota) consists of a foam plug with four central channels ( Fig. 24.3 ). It is placed within an incision and meant to span the body wall but is currently available in only one size (approximately 4 cm in length). Individual ports 5 to 15 mm in diameter are then placed through three of the channels. The fourth channel is used for gas insufflation.

Dedicated access devices are not necessarily required for the performance of LESS. Multiple low-profile ports can be placed through separate fascial punctures in one skin incision. The AnchorPort Single Incision Laparoscopy Kit (SurgiQuest, Milford, Connecticut) includes three specialized 5-mm ports that “self-anchor” to the abdominal wall and “self-adjust” to the thickness of the wall. The self-adjusting design minimizes the space occupied by the port both inside and outside the incision, allowing the ports to be placed in close proximity to each other. On completion of the LESS procedure, separate fascial defects are connected, both for ease of specimen retrieval and to facilitate adequate closure.

One creative solution for maintenance of a pneumoperitoneum with passage of multiple instruments is the use of a surgical glove applied over an Alexis Wound Retractor (Applied Medical). Holes are cut in the glove fingers through which any desired laparoscopic port is placed.