| Literature DB >> 25374656 |
N Lambrou1, R E Diaz1, P Hinoul2, D Parris3, K Shoemaker2, A Yoo2, M Schwiers2.
Abstract
A hybrid technique of robot-assisted, laparoscopic hysterectomy using the ENSEAL(®) Tissue Sealing Device is described in a retrospective, consecutive, observational case series. Over a 45 month period, 590 robot-assisted total laparoscopic hysterectomies +/- oophorectomy for benign and malignant indications were performed by a single surgeon with a bedside assistant at a tertiary healthcare center. Patient demographics, indications for surgery, comorbidities, primary and secondary surgical procedures, total operative and surgical time, estimated blood loss (EBL), length of stay (LOS), complications, transfusions and subsequent readmissions were analyzed. The overall complication rate was 5.9% with 35 patients experiencing 69 complications. Mean (SD) surgery time, operating room (OR) time, EBL, and LOS for the entire cohort were 75.5 (39.42) minutes, 123.8 (41.15) minutes, 83.1 (71.29) millilitres, and 1.2 (0.93) days, respectively. Mean surgery time in the first year (2009) was 91.6 minutes, which declined significantly each year by 18.0, 19.0, and 24.3 minutes, respectively. EBL and LOS did not vary -significantly across the entire series. Using the cumulative sum method, an optimization curve for surgery time was evaluated, with three distinct optimization phases observed. In summary, the use of an advanced laparoscopic tissue-sealing device by a bedside surgical assistant provided an improved operative efficiency and reliable vessel sealing during robotic hysterectomy.Entities:
Keywords: ENSEAL; hysterectomy; laparoscopy; robot-assisted; robotic; surgery
Year: 2014 PMID: 25374656 PMCID: PMC4216979
Source DB: PubMed Journal: Facts Views Vis Obgyn ISSN: 2032-0418
Fig. 1Port Placement and Surgical Assistant.
Original Cohort Procedure Profile by Indication for Surgery.
| Total Patients (N = 770) | n (%) |
|---|---|
| Laparoscopic Robot-Assisted Hysterectomy | 628 (81.6) |
| Total laparoscopic hysterectomy +/- USO/BSO1 | 601(78.1) |
| Total laparoscopic hysterectomy with BSO | 488 (63.4) |
| Total laparoscopic hysterectomy only | 112 (14.5) |
| Total laparoscopic hysterectomy with USO | 1 (0.13) |
| Radical hysterectomy | 23 (3.0) |
| Supracervical hysterectomy | 4 (0.5) |
| Laparoscopic Robot-Assisted Salpingectomy and Oophorectomy | 79 (10.3) |
| Salpingo-oophorectomy | 72 (9.4) |
| Oophorectomy | 5 (0.6) |
| Salpingectomy | 2 (0.3) |
| Other Primary Surgeries | 63 (8.2) |
| Myomectomy | 36 (4.7) |
| Cystectomy | 9 (1.2) |
| Debulking | 7 (0.9) |
| Miscellaneous (≤ 2) | 11 (1.4) |
1 BSO = Bilateral salpingo-oophorectomy, USO = Unilateral salpingo-oophorectomy.
Fig. 2Participant Flow Diagram.
Indications for Surgery and Comorbidity Score.
| Total patients (N = 590) | n (%) |
|---|---|
| Benign Indication | 459 (77.8) |
| Benign Neoplasms | 263 (44.6) |
| Uterine leiomyomas | 231 (39.2) |
| Ovary/Adnexa | 30 (5.1) |
| Cervix | 1 (0.2) |
| Genital organs, unspecified | 1 (0.2) |
| Non-Inflammatory Disorders | 56 (9.48) |
| Endometriosis | 39 (6.61) |
| Abnormal Bleeding | 37 (6.27) |
| Inflammatory Disorders | 11 (1.86) |
| Prolapse | 4 (0.7) |
| Other | 49 (8.3) |
| Malignant Indication | 103 (17.5) |
| Uterus | 79 (13.4) |
| Ovary/Adnexa | 12(2.0) |
| Cervix | 5 (0.8) |
| Other (Breast, Bone, Skin) | 7 (1.2) |
| Carcinoma In Situ (n = 28) | 28 (4.7) |
| Comorbidity Score | |
| 0 | 250(42.4) |
| 1 | 173 (29.3) |
| ≥ 2 | 167 (28.3) |
Univariate impact of preoperative diagnoses and secondary procedures.
| Pre-Operative Diagnoses | ||||
|---|---|---|---|---|
| Adhesions | Mean (SE) | Mean (SE) | Mean (SE) | Mean (SE) |
| Yes (n = 93) | 83.1 (8.47) | 1.34 (0.10) | ||
| No (n = 497) | 83.1 (3.57) | 1.23 (0.04) | ||
| Cancer | ||||
| Yes (n = 103) | 84.8 (8.13) | 1.36 (0.09) | ||
| No (n = 487) | 82.7 (3.60) | 1.22 (0.04) | ||
| Diabetes | ||||
| Yes (n = 36) | 77.9 (6.58) | 127.9 (6.86) | 78.9 (13.73) | 1.47 (0.15) |
| No (n = 554) | 75.4 (1.68) | 123.5 (1.75) | 83.3 (3.39) | 1.23 (0.04) |
| Endometriosis | ||||
| Yes (n = 210) | 72.0 (2.72) | 82.4 (5.44) | ||
| No (n = 380) | 77.5 (2.02) | 83.4 (4.13) | ||
| Elixhauser Comorbidity Index | ||||
| 0 (n = 250) | 70.9 (2.47) | 118.0 (2.57) | 79.0 (5.07) | 1.21 (0.06) |
| 1 (n = 173) | 74.0 (2.97) | 121.1 (3.08) | 86.5 (6.10) | 1.16 (0.07) |
| 2+ (n = 167) | 85.7 (6.12) | |||
| Secondary Procedures | ||||
| Adhesiolysis and Enterolysis | Mean (SE) | Mean (SE) | Mean (SE) | |
| Yes (n = 43) | 1.44 (0.14) | |||
| No (n = 547) | 1.23 (0.04) | |||
| Lymphadenectomy | ||||
| Yes (n = 38) | 75.9 (13.73) | 1.37 (0.15) | ||
| No (n = 552) | 83.5 (3.39) | 1.24 (0.04) | ||
| Morcellation | ||||
| Yes (n = 77) | 78.9 (13.73) | 1.17 (0.11) | ||
| No (n = 513) | 83.3 (3.39) | 1.26 (0.04) | ||
1 p < 0.02; 2 p < 0.05 for between group comparison.
Fig. 3Cumulative Summation Analysis – Optimization Curve.
Summary Statistics.
| Outcome | Time by Year | ||||
|---|---|---|---|---|---|
| Surgery time (min) | Overall (n = 590) | 2009 (n = 124) | 2010 (n = 164) | 2011 (n = 158) | 2012 (n = 144) |
| Mean | 75.54 | 91.57 | |||
| SD | 39.42 | 42.13 | 30.49 | 30.03 | 50.18 |
| Median | 66.00 | 81.50 | |||
| Minimum | 33.00 | 42.00 | 39.00 | 33.00 | 34.00 |
| Maximum | 483.00 | 363.00 | 204.00 | 260.00 | 483.00 |
| Operating room time (min) | Overall (n = 590) | 2009 (n = 124) | 2010 (n = 164) | 2011 (n = 158) | 2012 (n = 144) |
| Mean | 123.78 | 140.87 | |||
| SD | 41.15 | 42.74 | 33.20 | 31.81 | 51.54 |
| Median | 114.50 | 130.50 | |||
| Minimum | 72.00 | 78.00 | 76.00 | 75.00 | 72.00 |
| Maximum | 522.00 | 400.00 | 257.00 | 304.00 | 522.00 |
| Blood loss (ml) | Overall (n = 471) | 2009 (n = 105) | 2010 (n = 128) | 2011 (n = 131) | 2012 (n = 107) |
| Mean | 83.07 | 84.03 | 78.43 | 90.54 | 78.55 |
| SD | 71.29 | 62.03 | 65.90 | 81.53 | 72.72 |
| Median | 50.00 | 66.00 | 50.00 | 50.00 | 50.00 |
| Minimum | 0.00 | 39.00 | 0.00 | 0.00 | 5.00 |
| Maximum | 500.00 | 204.00 | 400.00 | 500.00 | 500.00 |
| Length of stay (days) | Overall (n = 590) | 2009 (n = 124) | 2010 (n = 164) | 2011 (n = 158) | 2012 (n = 144) |
| Mean | 1.24 | 1.27 | 1.30 | 1.17 | 1.24 |
| SD | 0.93 | 0.80 | 0.96 | 0.72 | 1.17 |
| Median | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 |
| Minimum | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 |
| Maximum | 11.0 | 7.0 | 8.0 | 8.0 | 11.0 |
1 = p ≤ .0005 by Analysis of Variance for comparison to 2009 ; 2 = p < 0.0001 by Wilcoxon Rank Sum test for comparison to 2009.