Total Robotic Radical Hysterectomy in Locally Advanced Cervical Cancer Patients after Neoadjuvant Chemotherapy

Abstracts / Journal of Minimally Invasive Gynecology 19 (2012) S36–S70 Study Objective: To determine the incidence of and risk factors for vaginal cuff dehiscence after all types of total hysterectomies, including abdominal (TAH), vaginal (TVH), laparoscopic assisted (LAVH), total laparoscopic (TLH), and robotic procedures (RATLH). Design: Retrospective analysis using ICD-9 codes was performed on all women who experienced a vaginal cuff dehiscence after total hysterectomy over ten-year period. Setting: Two academic teaching institutions in Florida. Patients: Women who experienced a vaginal cuff dehiscence after total hysterectomy. Intervention: Total hysterectomies by any route. Measurements and Main Results: Between 2000-2010 there were 4,135 total hysterectomies performed at the two institutions. There were a total of 8 dehiscences giving an overall incidence of vaginal cuff dehiscence of 0.19%. By route of hysterectomy, there was 1 dehiscence in the TLH category (incidence 0.59%, 95% CI -0.5-1.7), 1 LAVH (incidence 0.19%, 95 % CI -0.19-0.56), 1 RATLH (incidence 0.52%, 95% CI -0.50-1.6), 5 TAH (incidence 0.19%, 95% CI -0.02-0.36), and no dehiscences among the vaginal hysterectomies. Risk ratios of dehiscences after total laparoscopic hysterectomy compared to other modes of hysterectomy were as follows: compared to RATLH 0.89 (95% CI: 0.06-14.32), LAVH: risk ratio = 0.65 (95% CI: 0.06-7.26), TAH: risk ratio = 0.32 (95% CI: 0.04-2.78). There were no dehiscences observed in the vaginal group, so no risk ratios were calculated for this group. Case control analysis revealed no significant differences between the cases and controls in regard to any of the risk factors collected likely due to the small sample size. Conclusion: The overall risk of vaginal cuff dehiscence in our study was 0.19%, similar to that reported in the literature. Our reported incidence of dehiscence after TLH and robotic assisted TLH was much lower than previously reported. There does not appear to be an increased risk in vaginal cuff dehiscence after hysterectomy with minimally invasive procedures. 152

Open Communications 10dHysterectomy (3:38 PM d 3:43 PM)

The PREOPt Project Carugno JA, Gyang A, Hoover F, Taylor K, Lamvu G. Department of Graduate Medical Education. Division of Advanced Gynecology and Minimally Invasive Surgery, Florida Hospital-Orlando, Orlando, Florida Study Objective: The Physician Risk Estimation of OPerative time project is an effort to identify risk factors for prolonged operative time. In this first report, we identify patient characteristics that are associated with prolonged operative time and that are specific for robotic or laparoscopic total hysterectomy. Our long-term goal is to create a scoring system that can assist surgeons in predicting operative time based on patient characteristics. Design: Retrospective descriptive analysis followed by a predictive analysis. Setting: Tertiary center teaching hospital. Patients: A total of 1,290 patients underwent conventional total laparoscopic hysterectomy (732) or robotic total hysterectomy (558). Comparisons were performed for patient characteristics and their association to prolonged operative time. Intervention: Conventional laparoscopic or robotic total hysterectomy. Measurements and Main Results: Prolonged operative time was defined as R 180 minutes. Mean age was 46.28 (SD = 9.6). The robotic group was older with a mean age of 48.64 vs 44.48 in the conventional laparoscopy group (p = 0.00). Both groups were similar in race and BMI (mean BMI 29.06 (SD = 6.6)). Mean operative time was 115.79 minutes (SD: 60.37). In a preliminary analysis, obesity and history of myomectomy were the strongest factors associated with prolonged operative time. A definitive report analyzing other variables will be presented describing whether some patient variables are more important for robotic or conventional laparoscopic approach. Conclusion: In this cohort, both obesity and history of myomectomy are associated with operative time longer than 180 min. The ability to preoperatively identify patient characteristics that would increase the risk of prolonged operative time, will assist surgeons in adequate pre-operative planning and patient counseling and alert anesthesiologist and other OR personnel. It may even aid surgeons in determining when they should

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consider referring the patient to a facility better equipped to handle the challenges presented by cases with prolonged operative time. 153

Open Communications 10dHysterectomy (3:44 PM d 3:49 PM)

Analgesic Efficacy of Transversus Abdominis Plane Block Versus Local Injection in Postoperative Pain Management Following Minimally Invasive Gynecological Surgery Liberman EC,1 Denehy T,1 Schortz J,1 Dorian R,2 Hoffman J,3 Thomas M.2 1 Department of Obstetrics and Gynecology, Saint Barnabas Medical Center, Livingston, New Jersey; 2Department of Anesthesia, Saint Barnabas Medical Center, Livingston, New Jersey; 3Department of Pharmacology, Saint Barnabas Medical Center, Livingston, New Jersey Study Objective: To determine if there is a difference in postoperative pain after local injection of analgesia at port sites versus transversus abdominis plane block (TAP) in patients undergoing minimally invasive gynecological procedures. Design: Prospective, Double-Blind Randomized Clinical Trial. Setting: Community-based, university-affiliated teaching hospital. Patients: Inclusion criteria were patients aged > 18 scheduled to undergo minimally invasive gynecological surgery requiring an overnight hospital admission. Exclusion criteria included fibromyalgia, chronic pelvic pain, history of relevant drug allergy, or conversion to laparotomy. Sixty-eight subjects were randomly allocated to one of the three arms and completed the study. Intervention: Patients were randomly assigned to one of three arms: a.) placebo local injection, treatment TAP, b.) treatment local injection, placebo TAP, or c.) treatment local injection and treatment TAP. Time of injections, medications, and postoperative analgesic regimens were standardized among the arms. Measurements and Main Results: The primary outcome measurement was pain which was recorded for each patient using VAS (0-10) at time 1, 6, 24 hours after arriving in PACU. Secondary measurements consisted of time until first request for pain medication and total narcotic usage during admission. A statistical significance (p = 0.047) was noted in pain scores at 6 hours. Specifically, pain in the placebo local, treatment TAP arm was twice more than the treatment local, treatment TAP arm. Conclusion: There was no statistical difference among the arms of the study regarding age, weight, height, BMI, and length of surgery. Although not statistically significant, several trends were noted. Time until first request for pain medications was greatest in the treatment local, treatment TAP arm, and least in the treatment local, placebo TAP arm. Moreover, total narcotic usage was greatest in the treatment local, placebo TAP arm and least in the treatment local, treatment TAP arm. Subjects receiving treatment TAP appear to benefit over those receiving placebo TAP. 154

Open Communications 10dHysterectomy (3:50 PM d 3:55 PM)

Total Robotic Radical Hysterectomy in Locally Advanced Cervical Cancer Patients after Neoadjuvant Chemotherapy Vizza E,1 Corrado G,1 Mancini E,1 Baiocco E,1 Patrizi L,2 Saltari M,2 Sindico S,1 Cimino M,1 Francesco B.3 1Gynecologic Oncology Unit, National Cancer Institute ‘‘Regina Elena’’, Rome, Italy; 2Department of Surgery, Section of Gynecology and Obstetrics, ‘‘Tor Vergata’’ University, Rome, Italy; 3Gynecology and Obstetrics Unit, San Giovanni Hospital, Rome, Italy Objective: The aim of this report is to evaluate the feasibility and morbidity of total robotic class C1 radical hysterectomy (TRRH) with pelvic lymphadenectomy in patients with locally advanced cervical cancer after neoadjuvant chemotherapy (NACT). Methods: A prospective collection of data of all women underwent TRRH for cervical cancer stage IB2 to IIB, after neoadjuvant chemotherapy, was conducted at National Cancer Institute ‘‘Regina Elena’’of Rome. From August 1st 2010 to May 1st 2012 cervical cancer patients, stage IB2-IIB, with clinical response after 3 courses of NACT with paclitaxel 175 mg/

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Abstracts / Journal of Minimally Invasive Gynecology 19 (2012) S36–S70

m2, ifosfamide 5 g/m2 and cisplatin 75 mg/m2 (TIP) underwent TRRH , using the da Vinci robotic system. Results: All the 19 radical hysterectomies were performed with the use of all robotic arms, three robotic instruments, and one assistant trocar. Pathological evaluation showed 3 complete response (pCR), 2 partial response (pPR1) with microscopic tumour, and 14 partial response (pPR2) with macroscopic tumour. The mean operative time was 203,6 min (range, 120-300); the mean estimated blood loss was 250 ml (range,100-400), with two postoperative blood transfusion; the mean number of removed pelvic lymph nodes was 24,3 (range, 8-69). Conclusions: Our experience allowed us to note advantages of robotic surgery in the performance of radical hysterectomy performed in patients with stage IB2-IIB carcinoma of cervix after NACT, with of minimal blood loss and morbidity. 155

Open Communications 10dHysterectomy (3:56 PM d 4:01 PM)

A Randomized Controlled Trial of Barbed Versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results Einarsson JI,1 Wang KC,1 Cohen SL,1 Sandberg EM,1 Vree FEM,1 Jonsdottir GM,1 Gobern J,2 Brown DN.2 1Minimally Invasive Gynecologic Surgery, Brigham and Women’s Hospital, Boston, Massachusetts; 2 Minimally Invasive Gynecologic Surgery, Walter Reed National Military Medical Center, Bethesda, Maryland Study Objective: To compare closure times, cuff healing and postoperative dyspareunia between barbed and traditional suture when used for vaginal cuff closure during total laparoscopic hysterectomy. Design: Randomized controlled trial. Setting: Two tertiary-care academic medical centers. Patients: 64 women who planned total laparoscopic hysterectomy for benign indications. Patients were randomized utilizing a permuted block design to either QuillÔ or Vicryl suture and evenly allocated to either attending or trainee performing cuff closure. Intervention: Total laparoscopic hysterectomy was performed using standard techniques. Time required for cuff closure was documented. Patients were examined postoperatively to assess cuff healing and medical records were reviewed to ascertain if any complications occurred. A standardized sexual function questionnaire (FSFI) was administered preoperatively and at 3 months postoperatively. Measurements and Main Results: Baseline characteristics and indications for hysterectomy between the barbed and vicryl suture groups were similar. There was a trend toward more smokers in the vicryl suture group (23.3% versus 6.3%; p = .056). Mean vaginal cuff closure time was not significantly different (9.6 min for vicryl versus 10.4 minutes for barbed; p = .49); these findings were maintained with subgroup analyses of the attending and trainee surgeons. Intraoperative and postoperative complications were rare and not significantly different between groups. Regarding vaginal cuff healing, two patients experienced difficulty with bleeding from the cuff that required treatment (one from each group), three patients had dehiscence (two in the vicryl group, one in the barbed group) and two patients were treated for cuff cellulitis or abscess (one from each group). Conclusion: Barbed suture is a viable option for vaginal cuff closure during a total laparoscopic hysterectomy, and is not associated with any increase in complications. Data collection regarding effects on sexual functioning is underway. 156

Open Communications 10dHysterectomy (4:02 PM d 4:07 PM)

Do Residents and Fellows Really Slow You down? - A Prospective Determination of the Impact of Surgical Learners in the Gynecology OR Bates SK, Youash S, Levy K. Obstetrics and Gynecology, McMaster University, Hamilton, Ontario, Canada Study Objective: To determine the impact of Resident and Fellow participation in the surgery of women undergoing laparoscopic

hysterectomy. Primary outcomes were OR times and post-operative clinical outcomes. Design: All women undergoing laparoscopic hysterectomy during the 13 month period ending Dec 31, 2011 had concurrent prospective data regarding the surgery’s complexity (Surgical Complexity Index, (SCI)) entered into the OR database by the surgeon immediately following the OR. Postoperative clinical outcomes were divided into those attributable and non-attributable to the prolonged period of general anesthesia. Other predictor variables were derived from the Hospital’s databases and patients’ chart. Multiple regression techniques were used to analyze the data. Setting: Community Hospital with Residents and Fellows. Measurements and Main Results: In total, 219 women underwent laparoscopic hysterectomy during the study period. Mean OR time was 182 min. (SD = 54 min). If the Resident and/or Fellow performed most of the procedure the OR time was extended by 24.5 minutes. (p \ 0.001). After adjustment for covariates extent of resident participation was not a predictor of post-operative complications. The overall complication rate attributable to the prolonged period of general anesthesia was 1.5%. After adjustment for surgical complexity (SCI), OR time was a statistically significant predictor of the probability of attributable postoperative complications (p = .034). For the 3 patients with attributable complications, OR time was 269 min. versus 182 min for those without. The prospectively derived SCI score was a strong predictor of OR time (p\. 001). Conclusion: In women undergoing hysterectomy, the longer OR times associated with the laparoscopic route of access leads to very low attributable complication rates. However, there is a definite increase in these complications with very long procedures. Surgical complexity predicts longer OR times. Full Resident or Fellow participation prolongs surgery by a (arguably) ‘‘clinically significant’’ degree.

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Open Communications 10dHysterectomy (4:08 PM d 4:13 PM)

Effect of Electrosurgery for Initial Incision at the Time of Vaginal Hysterectomy Lavallee MA,1 Morosky CM.2 1Obstetrics and Gynecology, University of Connecticut School of Medicine, Farmington, Connecticut; 2Obstetrics and Gynecology, The Hospital of Central Connecticut, New Britain, Connecticut Study Objective: An increased incidence of vaginal cuff dehiscence has been documented in the setting of total laparoscopic and robotic hysterectomies. One of the proposed etiologies of this increase is the use of electrosugery to laparoscopically perform colpotomy. The aim of this study was to determine if there is a similar increase in vaginal cuff dehiscence when electrosugery is used for the initial incision at the time of vaginal hysterectomy. Design: We performed a multi-centered retrospective chart review of all patients undergoing trans-vaginal hysterectomy (TVH) or laparoscopicassisted vaginal hysterectomy (LAVH) from January 1, 2005 to December 31, 2010. Patients: Inclusion criteria were all women undergoing TVH or LAVH where the incision into the vaginal epithelium was performed vaginally with either a cold scalpel or monopolar electrosurgery. Exclusion criteria were women who either primarily underwent or were secondarily converted to alternate routes of hysterectomy. Intervention: Patient charts were followed until April 1, 2012 for hospital readmission. The primary outcome was readmission for vaginal cuff dehiscence. Secondary outcomes included readmission for other complications such as bleeding, infection or deep vein thrombosis. Measurements and Main Results: A total of 128 energy group and 270 scalpel group patients were identified. Both groups were similar in respect to mean age, body mass index, estimated blood loss and uterine weight. There were no vaginal cuff dehiscence readmissions noted in either group. There was no difference in total or individual complications noted in either group.