Minimally Invasive Gynecological Surgery

18. Learning Curve and Perioperative Outcomes Associated with Laparoendoscopic Single-Site Surgery

Camille Catherine Gunderson1, 2   and Amanda Nickles Fader1, 3  

(1)

Department of Gynecology and Obstetrics, Johns Hopkins Medical Institutions, Baltimore, MD, USA

(2)

325 NE 4th Street #1, Oklahoma City, OK 73104, USA

(3)

Department of Gynecology and Obstetrics, Division of Gynecologic Oncology, Greater Baltimore Medical Center/Johns Hopkins Medical Institutions, Baltimore, MD, USA

Camille Catherine Gunderson (Corresponding author)

Email: ccgunder@gmail.com

Amanda Nickles Fader

Email: amandanfader@gmail.com

18.1 Introduction

18.1.1 Pain Associated with LESS

18.1.2 Infection Associated with LESS

18.1.3 Hernia Associated with LESS

18.1.4 Cosmesis Associated with LESS

18.1.5 Convalescence Associated with LESS

18.1.6 Learning Curve Associated with LESS

18.1.7 Future Directions Associated with Laparoendoscopic Single-Site Surgery

18.2 Conclusion

References

18.1 Introduction

Single-port laparoscopic surgery is a novel minimally invasive technique that is being increasingly utilized in gynecologic surgery. Although numerous terms are associated with this technique, it was recently determined that the most accurate and scientific terminology is laparoendoscopic single-site surgery (LESS) (Gill et al. 2010). This approach involves performing a surgical procedure through a single, small umbilical incision (1.5–2.5 cm) employing specialized multichannel, single-port technology. Published reports in the general surgery, urologic, and gynecologic literature demonstrate safe and reproducible results with LESS utilized for a variety of procedures including cholecystectomy, nephrectomy, splenectomy, hysterectomy, and adnexal surgery, among others (Fader et al. 2010; Desai et al. 2009; White et al. 2009; Froghi et al. 2010; Fumagalli et al. 2010). Initial reports in the gynecologic literature have demonstrated the feasibility of LESS for the performance of a variety of benign and oncologic procedures with excellent clinical outcomes and overall low rates of major perioperative morbidity, ranging from 1 to 3 % (Fader et al. 2010; Lee et al. 2010; Kim et al. 2009; Fader and Escobar 2009; Escobar et al. 2009; Escobar et al. 2010; Cho et al. 2007; Kalogiannidis et al. 2007).

18.1.1 Pain Associated with LESS

For abdominal or pelvic procedures, LESS is performed exclusively through the base of the umbilicus. Thus, in theory, the single incision should yield less pain than conventional laparoscopy as it utilizes the privileged location of the umbilicus: the relatively avascular, thinnest portion of the anterior abdominal wall. Prior studies have demonstrated that in conventional laparoscopy, specimen extraction through an umbilical port leads to less postoperative pain than extraction via a lateral port (Chou et al. 2010). There is a paucity of high-quality data evaluating postoperative pain associated with LESS as it is a relatively new technique. In one of the larger series of women undergoing gynecologic single-port laparoscopic surgery, 38 % did not require narcotic use as an outpatient (Fader et al. 2010). Retrospective data has demonstrated decreased pain with single-port laparoscopic hysterectomy as compared to conventional total laparoscopic hysterectomy (TLH) (Yim et al. 2010; Kim et al. 2010). Furthermore, a recent randomized controlled trial reported decreased pain scores on a visual analog scale and lesser analgesia requirements with single-port laparoscopic-assisted vaginal hysterectomy (LAVH) as compared to conventional LAVH (Chen et al. 2011). Fagotti et al. also demonstrated decreased immediate postoperative pain and less postoperative analgesia requirements in another randomized prospective study including women undergoing surgery for benign adnexal disease (Fagotti et al. 2011). However, other prospective studies have not found a difference in postoperative pain scores and analgesia requirements with LESS (Jung et al. 2011; Li et al. 2012). At this time, the available data suggest similar or better pain profiles with LESS as compared to conventional laparoscopy for gynecologic procedures (Table 18.1).

Table 18.1

Comparison of outcomes with LESS in gynecology (as compared to conventional laparoscopy when applicable)

Study

Pain

Infection

Hernia

Convalescence

Complications

 

Chen et al.

VAS:

NR

NR

NR

2 % (vs. 4 %)

 

24 h postop: 3.6 ± 2.8 vs. 5.1 ± 2.8, p = 0.011

p > 0.999

 

48 h postop: 1.9 ± 2.3 vs. 2.8 ± 2.1, p = 0.043

 

Analgesia usage:

 

Total meperidine dosage (mg): 74.4 ± 24.3 vs. 104.8 ± 57.1, p = 0.001

 

Total NSAID dosage (mg): 16.0 ± 13.4 vs. 33.6 ± 28.7, p < 0.001

 

Cho et al. (2012)

VAS:

NR

NR

Return to work (days):

   

After 24 h: 3.3 ± 1.9 vs. 3.5 ± 2.0, p = NS

 

7.4 ± 3.8 vs. 6.4 ± 3.5, p = NS

 

After 48 h: 2.3 ± 1.4 vs. 2.2 ± 1.6, p = NS

 

Analgesia usage:

 

Intramuscular use within 24 h: 0.4 ± 0.7 vs. 0.3 ± 0.5, p = NS

 

Oral use after discharge: 1.3 ± 1.8 vs. 0.9 ± 1.5, p = NS

 

Fader et al. (2010)

38 % did not require outpatient narcotic usage

1.4 %

NR

NR

4 %

 

Fagotti et al.

VAS:

NR

NR

NR

3 % vs. 0 %, p = 0.5

 

2 h postop: p = 0.02

 

4 h postop: p = 0.004

 

Upon discharge: p = NS

 

Analgesia usage:

 

8 vs. 21 of paracetamol, p = 0.001

 

Gunderson et al.

NR

5.2 %

2.4 %

NR

2.4 %

 

Kim et al. (2010)

VAS:

0 % vs. 0 %

NR

NR

0 % vs. 0 %

 

After 24 h: 2.5 ± 0.7 vs. 3.5 ± 0.8, p = 0.01

 

After 36 h: 1.7 ± 1.2 vs. 2.9 ± 1.1, p = 0.01

 

Lee et al.

Request for additional analgesic medications:

0 % vs. 0 %

NR

NR

0 % vs. 0 %

 

7 patients vs. 19 patients, p = 0.597

 

Li et al.

Patients requiring postop analgesics: 7.7 % vs. 10.7 %, p = NS

1.9 % vs. 8.9 %, p = 0.03

0 % vs. 0 %

Duration of immobilization (h): 14.6 ± 2.1 vs. 15.7 ± 2.3, p = 0.01

0 % vs. 0 %

 

NR not recorded, LESS laparoendoscopic single-site surgery, VAS visual analog scores, NSAID nonsteroidal anti-inflammatory drugs, NS not significant

18.1.2 Infection Associated with LESS

The incidence of incisional cellulitis or wound infection with LESS appears to be at least comparable to that of conventional laparoscopy. In a large multi-institutional series of women undergoing LESS for a gynecologic procedure, 5.2 % of women developed umbilical cellulitis. None of these patients required readmission or an additional procedure to manage this minor complication, and obesity was found to be significantly associated with umbilical morbidity (Gunderson et al. 2012). However, some reports have actually concluded lower rates of infection with LESS. In a prospective randomized trial of 108 women undergoing hysterectomy via LESS or conventional total laparoscopic hysterectomy (TLH), Li et al. reported a 1.9 % infection rate with LESS versus 8.9 % with TLH (p = 0.03) (Li et al. 2012).

Concern rightfully exists regarding the occult bacteria that the umbilicus may harbor, even after a sterilizing prep is applied. The American College of Obstetricians and Gynecologists does not routinely recommend antibiotic prophylaxis for adnexal surgery without hysterectomy (ACOG 2009). However, we propose consideration of antibiotic use with any LESS procedure in concordance with the individual’s umbilical anatomy, planned procedure, and underlying comorbidities.

18.1.3 Hernia Associated with LESS

Given the larger size of the umbilical incision required for LESS as compared to conventional laparoscopy, there is a theoretically increased risk of umbilical hernia formation. Furthermore, it is well understood that the incidence of hernia formation correlates with incision size, complexity and length of procedure, and underlying comorbidities (Kadar et al. 1993; Boike et al. 1995). However, the available data encompassing LESS in gynecology actually suggests a comparable rate of hernia formation to that of conventional laparoscopy. In a series of 211 women undergoing LESS for a variety of gynecologic procedures, Gunderson et al. noted a 2.4 % incidence of umbilical hernia formation when utilizing a 1.5–2.5 cm umbilical incision (Gunderson et al. 2012). It should be noted that the authors of this study used a meticulous incisional closure technique to reapproximate the fascia in a “mass closure” fashion and reattach the fascia to the umbilical stalk. Prospective studies are warranted to further validate these findings.

18.1.4 Cosmesis Associated with LESS

Advocates of the LESS approach deem that the single umbilical incision is cosmetically preferable to the multiple smaller incisions associated with conventional laparoscopy. The single central incision is relatively “scarless” as it may be easily concealed within the umbilicus. Several years ago, it was proposed that this predilection was purely surgeon speculation and was not based on objective information regarding actual patient preferences (Ramirez 2009). However, data have subsequently emerged which dispute this claim. Park et al. surveyed patients undergoing urologic surgery and found that they favored the cosmetic outcomes of LESS as compared to conventional laparoscopy or laparotomy (Park et al. 2011). This validation has also been recognized within the gynecologic surgery literature. Higher patient satisfaction scores were reported with LESS hysterectomy as compared to TLH (Li et al. 2012). Additionally, a recent randomized controlled trial noted a statistically significant higher rate of satisfaction by both the patient and the surgeon with the cosmetic result of LESS for benign adnexal surgery as compared to conventional laparoscopy. The improved satisfaction scores were noted both upon discharge from the hospital and 30 days postoperatively (Fagotti et al. 2011).

18.1.5 Convalescence Associated with LESS

The single incision and seemingly decreased pain associated with LESS may yield quicker convalescence. Yim et al. retrospectively reported earlier diet intake (p < 0.001) and shorter hospital stay (p = 0.001) with LESS hysterectomy as compared to TLH (Yim et al. 2010). However, other studies have demonstrated no difference in length of postoperative hospital stay (Li et al. 2012; Fagotti et al. 2011). With the current available data, it seems that convalescence after LESS is at least as rapid as that of conventional laparoscopy.

18.1.6 Learning Curve Associated with LESS

There is an undeniable learning curve associated with any new surgical technique. LESS imposes unique challenges as it precludes the triangulation which a surgical team utilizes with conventional multiport laparoscopy. Instrument collision (“sword fighting”) and difficulty with overcoming in-line visualization are perhaps two of the greatest challenges. The use of flexible tip laparoscopes and articulating instruments can assist in restoring the typical intracorporeal triangulation to maximize exposure and allow for countertraction.

Efficiency has become a topic of interest as technology has allowed minimally invasive approaches to become more widely embraced. This is paramount considering the risk and cost incurred while under general anesthesia. Several retrospective studies in the gynecology literature have noted similar operative times for LESS as compared to conventional laparoscopy. Bedaiwy et al. studied a group of 78 women and reported a 1 min difference in operative time with LESS versus conventional laparoscopy for adnexectomy (p = 0.08) (Bedaiwy et al. 2012). Furthermore, Yim et al. reported 117 min for LESS hysterectomy versus 110 min with TLH (p = 0.924) (Yim et al. 2010). A randomized controlled trial by Cho et al. further supports similar operative times with LESS and conventional laparoscopy (Cho et al. 2012).

Fader et al. reported the first learning curve analysis for LESS hysterectomy and bilateral salpingo-oophorectomy (BSO). Therein, the authors described a dramatic reduction in operative time between the tenth and twentieth cases (Figs. 18.1 and 18.2). The results did achieve statistical significance, both with time for entry and port insertion (p < 0.001) and for total operative time (p = 0.002). This trend applied to both cancer staging and benign procedures. The decrease in operative time stabilized after 20 cases were performed by a uniform team; these results suggest performance of a minimum of 20 cases for proficiency (Fader et al. 2010).

A304172_1_En_18_Fig1_HTML.gif

Fig. 18.1

Learning curve of LESS with benign procedures

A304172_1_En_18_Fig2_HTML.gif

Fig. 18.2

Learning curve of LESS with cancer staging procedures

18.1.7 Future Directions Associated with Laparoendoscopic Single-Site Surgery

As we continue to embrace new minimally invasive approaches, it is crucial to ensure safety and efficacy in order to minimize morbidity. As with the introduction of any new technique, the initial data is largely retrospective and involves relatively small cohorts of subjects. Well-designed larger and randomized trials are required to validate the results of the early studies and to effectively compare LESS to other minimally invasive surgical approaches.

Another exciting innovation will be the merger of LESS is with the da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA). Escobar and Fader et al. reported the first successful robotic-assisted LESS hysterectomy/BSO in 2009; this was performed as a risk-reducing procedure in a woman with a BRCA mutation. The procedure was performed with the da Vinci S robot utilizing a GelPort (Applied Medical, Rancho Santo Margarita, CA) through which a 30°, 12-mm robotic laparoscope was inserted, along with two standard 8 mm robotic trocars (Escobar et al. 2009). Since then, Escobar et al. have described a cadaveric model to apply robotic-assisted LESS to perform several gynecologic oncology procedures (Escobar et al. 2011). The da Vinci single-port surgery adaptation is currently undergoing investigation and FDA approval, and its emergence on the market is eagerly anticipated.

18.2 Conclusion

Although once developed as an extension of conventional laparoscopy, LESS has now established itself as an independent surgical approach with its own unique benefits and indications. The goals in employing LESS technology are to minimize postoperative pain and complications, decrease convalescence time, and optimize cosmetic results. Although initial studies in the gynecologic and nongynecologic surgical literature have demonstrated the feasibility, safety, and reproducibility of this approach, these results must be validated. Additionally, further questions remain to be answered including the long-term risks and benefits as well as the cost-effectiveness of LESS. In the process of collecting data to address these crucial uncertainties, more information can be gathered regarding the learning curve and optimal setting for the application of LESS.

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