Objective
The study objectives were to determine the surgical outcomes of a large series of gynecology patients treated with laparoendoscopic single-site surgery (LESS).
Study Design
This was a retrospective, multi-institutional analysis of gynecology patients treated with LESS in 2009. Patients underwent surgery via a single 1.5- to 2.5-cm umbilical incision with a multichannel single port.
Results
A total of 74 women underwent LESS. Procedures were performed for benign pelvic masses (n = 39), endometrial hyperplasia (n = 9), endometrial (n = 15) and ovarian (n = 6) cancers, and nongynecologic malignancies (n = 5). Median patient age and body mass index were 47 years and 28, respectively. A Pearson product-moment correlation coefficient was computed and demonstrated a significant linear relationship between the operating time and number of cases for cancer staging (r = –0.71; n = 26; P < .001) and nonstaging (r = –0.78; n = 48; P < .002) procedures. Perioperative complications were low (3%).
Conclusion
LESS is feasible, safe, and reproducible in gynecology patients with benign and cancerous conditions. Operative times are reasonable and can be decreased with experience.
Laparoendoscopic single-site surgery (LESS), also known as single-port surgery, is a novel, rapidly advancing minimally invasive technique. LESS is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. Recent data in the general surgery and urology literature have demonstrated technical feasibility and reproducibility of this technique when utilized for a variety of procedures, including cholecystectomy, appendectomy, nephrectomy, and hemicolectomy. These early reports indicate that LESS is a promising surgical innovation that results in improved cosmesis for patients, and in many cases, results in a shorter convalescence period and decreased postoperative analgesia requirements when compared to patients treated with conventional laparoscopic approaches.
Laparoscopy has become the standard treatment for many gynecologic conditions. In the last 2 decades, numerous studies have demonstrated that laparoscopic approaches to various benign and cancerous gynecologic diseases result in shorter hospital stays, improved quality of life, and improved surgical outcomes when compared to abdominal staging. There are few reports in the literature regarding LESS for gynecologic conditions other than case reports or small, retrospective series. Previously, our group described the first report in the literature of robotic-assisted LESS gynecologic surgery, as well as the initial technique for LESS risk-reducing total laparoscopic hysterectomy (TLH) and bilateral salpingo-oophorectomy (BSO) in patients at high risk for ovarian cancer, the initial report on LESS staging of gynecologic malignancies, and a case series on LESS for the treatment of pelvic masses. These studies demonstrated preliminary feasibility and safety of LESS in the treatment of various benign and oncologic female conditions. Validation of these early series with larger studies is imperative. Furthermore, data are needed regarding the learning curve for gynecologic LESS procedures to determine the practicality and reproducibility of this surgical approach. Therefore, the primary objective of the current study is to determine the surgical outcomes of a large series of gynecology patients with either benign or early-stage cancer diagnoses treated with LESS. A secondary objective is to perform a learning curve analysis of LESS gynecologic procedures.
Materials and Methods
Patient and surgical characteristics
This retrospective, multi-institutional study was approved by the institutional review board at each participating center. Eligible patients included women treated on 1 of 3 gynecologic oncology services at participating institutions (Cleveland Clinic, Cleveland, OH; Greater Baltimore Medical Center, Baltimore, MD; and Avera McKenna Hospital, Sioux Falls, SD) who were deemed to be reasonable candidates for laparoscopic surgery and underwent a LESS procedure. Patients may have had a preoperative diagnosis of benign or malignant disease. For those with cancer, only apparent, early-stage gynecologic cancer patients were included or women with an advanced, nongynecologic cancer that involved a gynecologic organ or required diagnostic laparoscopy. Ineligible patients were those who had undergone at least 2 previous laparotomy surgeries (with midline vertical incisions), had a uterus or ovarian mass >16 cm, had a preoperative diagnosis of advanced malignancy, or who had undergone LESS for risk-reducing TLH, BSO, or both, as these patient outcomes will be presented in a separate manuscript. Participating attending surgeons were all gynecologic oncologists with advanced conventional laparoscopic training in pelvic and paraaortic lymphadenectomy, radical hysterectomy, endometriosis, and upper abdominal techniques.
Patient demographics and surgical and postoperative data were collected. Operative times were recorded electronically and were defined as the interval between incision start to closure. Body mass index (BMI) (mg/kg 2 ) was categorized by standard World Health Organization criteria. Data collection also included perioperative complications and patient use of postoperative narcotics as recorded electronically by nursing staff for inpatient use and subjectively by patients after discharge.
Instruments
All cases were performed by a 2-surgeon team. When indicated, a V-Care Uterine Manipulator (Conmed Endosurgery, Utica, NY) was utilized. Patients underwent surgery through a single 1.5- to 2.5-cm vertical umbilical incision (as measured by a sterile ruler), performed via an open Hasson approach. Incisions were made at the base of the umbilicus. Two different multichannel, single-port systems were utilized. The SILS Port Multiple Instrument Access Port (Covidien, Mansfield, MA) is a multi-instrument access port that allows up to 3 laparoscopic instruments (three 5-mm cannulas or two 5-mm and one 12-mm cannula) to be used simultaneously through separate flexible channels. A second multichannel port used was the Gelpoint (Applied Medical, Rancho Santa Margarita, CA), a smaller, single-port version of the Alexis wound retractor (Applied Medical) with a Gelseal cap (Applied Medical). Endoscope systems utilized included the rotatable 30-degree Visera EndoEye laparoscope (Olympus America Inc, Center Valley, PA) or the Stryker (San Jose, CA) 30- or 45-degree bariatric length laparoscope with an angled light cord adapter. Articulating atraumatic instruments were also utilized in some cases. Multifunctional instruments including the 5-mm Ligasure Advance (Covidien) or the Harmonic scalpel (Ethicon Endosurgery, Cincinnati, OH) were utilized in all cases.
Statistics
Patient clinical and demographic characteristics and surgical outcomes were compared between benign/precancerous cases and cancer cases by use of Student t test, Fisher’s exact test, or the Wilcoxon rank sum test (utilized when variables were not normally distributed). A learning curve analysis of cancer staging procedures (CSPs) and nonstaging procedures (NSPs) was performed. A Pearson product-moment correlation coefficient was computed to assess the relationship between operative time and number of cases. Fisher’s exact test or analysis of variance was employed to compare the procedure times. Specifically, single-port insertion time and total operative time was analyzed for all LESS TLH/BSO cases (n = 31). Patients were arranged in sequential order based on surgery date and operative times were analyzed among quartiles (quartile 1 defined as TLH/BSO cases 1-10, quartile 2 defined as cases 11-20, and quartile 3 defined as cases 21-31). A 2-surgeon team (P.F.E. and A.N.F.) performed the cases analyzed in the TLH/BSO learning curve analysis.
Results
In all, 74 patients underwent an attempted LESS gynecologic procedure during the study period, and 96% were performed successfully through a single umbilical incision. Specifically, 2 endometrial cancer patients were converted to open and conventional laparoscopic approaches, respectively, due to prohibitive adhesive disease, and 1 postmenopausal patient with a complex pelvic mass and elevated CA-125 was converted to laparotomy when ovarian cancer with metastatic pelvic implants were identified intraoperatively. Median patient age and BMI were 49 years and 28, respectively. Patient demographics and surgical characteristics are outlined in Table 1 and compare those patients who had LESS performed for benign/precancerous conditions to those with a cancer diagnosis. There were no differences in outcomes between groups for BMI, comorbidities, history of surgeries, or mean hospital stay. Procedures were performed for benign pelvic masses (n = 39), endometrial hyperplasia (n = 9), endometrial (n = 15) and ovarian (n = 6) cancers, and nongynecologic malignancies (n = 5). The specific procedures performed for the above indications are listed in Table 1 , and the LESS techniques utilized to perform these procedures have been reported previously.
