Rate of detecting CIN3+ among patients with ASC-US using digital colposcopy and dynamic spectral imaging.

The present study compared two methods for the detection of severe cervical dysplasia in women with atypical squamous cells of underdetermined significance (ASC-US) cytology; digital colposcopy with adjunctive dynamic spectral imaging (DSI) and conventional colposcopy. IMPROVE-COLPO was a two-arm cross-sectional study of US community-based colposcopy. The active (prospective) arm of this study recruited patients examined by digital colposcopy and adjunctive DSI. Preceding consecutive patients that had been examined with conventional methods were used as historical controls in the retrospective arm of the study after being matched in number to those in the prospective arm by a colposcopist. In the present study, the primary measure was the number of women detected with cervical intraepithelial neoplasia (CIN) grade 3 or worse (CIN3+) following punch biopsy. The study included 1,353 retrospective and 1,226 prospective patients eligible for this analysis who were examined by 146 colposcopists in 42 community-based clinics. The patient baseline characteristics were comparable between the two arms. The average number of biopsies taken per patient was higher among the prospective arm patients (including standard and DSI-assisted biopsies) compared with the retrospective arm control patients (1.21 vs. 0.97 respectively). Biopsy detected 31 patients with CIN3+ [2.29%; 95% confidence interval (CI), 1.56-3.24] in the retrospective arm, and 48 patients with CIN3+ (3.92%; 95% CI, 2.90-5.16) in the prospective arm. The difference in the number of patients detected with CIN3+ in the two arms of the study was 1.62% (95% CI, 0.30-3.04; P=0.022), which corresponds to a 70.9% relative increase in the prospective compared with the retrospective arm. Biopsy appeared less efficient in detecting patients with CIN3+ in the retrospective arm compared with the prospective arm. However, there was no statistically significant difference between the retrospective arm and the prospective arm in terms of: i) Biopsies taken (over the entire population) per patient detected with CIN3+ (42.2 in the retrospective arm vs. 30.8 in the prospective arm; P=0.164) and ii) positive predictive value of using biopsies to identify patients with CIN3+ (2.83 vs. 3.92; P=0.118). Adoption of digital colposcopy with DSI increased the number of biopsies collected from ASC-US patients compared with retrospective controls of standard colposcopy and detected a significantly higher number of patients who were CIN3+. The number of additional biopsies taken in the prospective arm compared with the retrospective arm was too small to explain the increased detection of patients with CIN3+ observed in the prospective arm, suggesting that biopsies in the prospective arm were better at identifying CIN3+.

Increased detection of precancerous cervical lesions with adjunctive dynamic spectral imaging.

OBJECTIVE: To validate, in US community-based colposcopy clinics, previous reports of increased detection of high-grade cervical intraepithelial neoplasia (CIN2+) with biopsies selected using dynamic spectral imaging (DSI) mapping after standard colposcopy. STUDY DESIGN: Cross-sectional observational study of 26 colposcopists across nine clinics recruiting consecutive colposcopy patients. Standard assessment with biopsy selections was completed before seeing the DSI map which was subsequently interpreted and used for additional biopsies per clinical judgment. Primary measure was the number of women with CIN2+ detected by DSI-assisted biopsies, over those detected by standard colposcopy biopsies. RESULTS: A total of 887 women were recruited. After exclusions, 881 women and 1,189 biopsies were analyzed. Standard biopsy detected 78 women with CIN2+ and DSI-assisted biopsies another 34, increasing the detection rate from 8.85% to 12.71% (p=0.00016). This was achieved with 16.16% of DSI-assisted biopsies finding CIN2+ compared to 13.24% for the preceding standard biopsies. For secondary specificity analysis, 431 women had only

Robotic-assisted laparoscopic hysterectomy and lymphadenectomy for endometrial cancer: Analysis of surgical performance.

OBJECTIVES: To provide an objective analysis of surgical performance of robotic-assisted laparoscopic hysterectomy (RALH) with lymphadenectomy for endometrial cancer during the learning phase of the procedure and to assess opportunities for improvement. METHODS: From July 2006 to March 2008, 100 patients with endometrial cancer underwent RALH with lymphadenectomy using the da Vinci Robotic Surgical System. Data were analyzed for operative time (OT), estimated blood loss (EBL), length of stay (LOS), intra-operative complications, surgical-pathologic factors, and post-operative complications using an intent-to-treat analysis. A comparison of the data on a quartile (Q) basis was performed for the 100 RALH cases and separately for the 65 cases that had a complete pelvic-and-aortic lymphadenectomy (PAL). RESULTS: Age and body mass index (BMI) did not change significantly during the study. More grade 3 tumors were treated in the last 50 cases (22% vs. 10%, p<0.05). Stage III tumors were identified in 18.7% cases in Q2-4 and none in Q1 (p<0.05). The number of patients undergoing complete PAL and the number of aortic lymph nodes (LN) removed per case increased each quarter. There were 4 (4%) conversions to laparotomy. Delayed vaginal cuff healing decreased from 16% in Q1 to 0% in Q3-4. No case required blood transfusion. Comparing first 10 cases to the last 10 cases, the total LN counts increased from 15 to 21 nodes, the aortic LN counts increased from 4.7 to 8.0, and the OT decreased from 203 to 160 min. Intra-surgeon analysis revealed an improvement in the total LN yields from first 50 to second 50 cases for each surgeon. CONCLUSIONS: Operative times decreased and aortic dissections improved with increasing LN counts during the first 100 cases of RALH. Furthermore, patient safety and improvement in surgical performance was demonstrated.

Robotically assisted laparoscopic hysterectomy versus total abdominal hysterectomy and lymphadenectomy for endometrial cancer.

OBJECTIVE: To compare surgical morbidity and clinical-pathologic factors for patients with endometrial cancer (EC) undergoing robotic-assisted laparoscopic hysterectomy (RALH) versus total abdominal hysterectomy (TAH) with aortic and/or pelvic lymphadenectomy (LA). METHODS: During the first 14 months of a robotics surgical program, 56 patients with EC were scheduled to undergo RALH with LA. Cases were analyzed for operative (op) time, estimated blood loss (EBL), transfusion, intra- and post-op complications, surgical-pathologic data, patient demographics and length of stay (LOS). Data was compared to 106 serially treated patients with EC who underwent TAH with LA immediately prior to initiation of our robotics program. RESULTS: Three robotic cases (5.4%) were converted to TAH secondary to intra-op factors. FIGO stages for RALH vs. TAH were: stage I (82 vs. 69%), stage II (7 vs. 7.5%) and stage III (11 vs. 21.5%). Patients' mean age was 59+/-10 vs. 63+/-11 years (p=0.05) and body mass index (BMI) was 29+/-6.5 vs. 34+/-9 kg/m(2) (p=0.0001) for the robotic and open groups, respectively. Severe medical co-morbidities affected 5.4% of robotic patients compared to 8.5% of open cases (p>0.05). Comparing RALH and TAH, mean op time was 177+/-55 vs.79+/-17 min (p=0.0001), EBL was 105+/-77 vs. 241+/-115 ml (p<0.0001), transfusion was 0 vs. 8.5% (p=0.005), and LOS was 1.0+/-0.5 vs. 3.2+/-1.0 days (p<0.0001). Robotic patients incurred a 3.6% major peri-operative complication rate while women undergoing open procedures had an incidence of 20.8% (p=0.007). Total lymph node count was 19+/-13 nodes for robotic cases vs. 18+/-10 nodes obtained from open hysterectomy patients. CONCLUSIONS: Patients with EC who underwent RALH with LA during the first year of our robotics program were younger, thinner and had less cardio-pulmonary illness than patients previously treated with TAH and LA. LOS, EBL and peri-op complication rates were significantly lower for the robotic cohort.

Clinical-pathologic and morbidity analyses of Types 2 and 3 abdominal radical hysterectomy for cervical cancer.

OBJECTIVE: To provide representative data analyses of surgical morbidity and clinical-pathologic factors for Types 2 and 3 abdominal radical hysterectomies (ARH) with pelvic+/-aortic node dissection performed in a private practice with a fellowship-training program. METHODS: From 1997 to 2005, 329 cervical cancer patients underwent ARH with lymphadenectomy. Two hundred and one cases performed at our primary institution were analyzed for operative time, blood loss, intra-operative complications, surgical-pathologic data, recurrence of disease and adjuvant therapy. RESULTS: We evaluated 201 surgical patients who underwent Type 2 (n=45) or Type 3 (n=156) ARH with node dissection. The FIGO stages were: IB1=64%, IB2=6.5%, IA=28.4%, and IIA=1%. Aortic node dissection was performed in 64% of Type 3 cases and none of Type 2 cases. Pfannenstiel incision was used in 80% (Type 2) and 76% (Type 3) cases. A suprapubic catheter was placed in 9% of Type 2 and 81% of Type 3 cases. Median age and weight were 47+/-13 years and 149+/-35 lb. Positive nodes were identified in 12% of Type 3 and 2.2% of Type 2 cases. No positive aortic nodes were found. For Types 2 and 3 ARH, median operative time was 80+/-19 vs. 99+/-23 min (p<0.001) and blood loss was 250+/-134 vs. 300+/-234 ml (p<0.001). The transfusion rate was 3%. Intra-operative complications included: 3 ureteral injuries and 1 colotomy. Tumor histology was 60% squamous, 37% adenocarcinoma, 1% adenosquamous, and 2% others. CONCLUSIONS: ARH with pelvic lymphadenectomy in modern practice is an efficient, safe procedure with low transfusion rate and shorter hospital stay than previously reported. Data will be useful as comparison when scrutinizing novel approaches to radical hysterectomy including robotic-assisted and laparoscopic techniques.