| Literature DB >> 31997510 |
Natalya Danilyants1, Mamta M Mamik2, Paul MacKoul1, Louise Q van der Does1, Leah Haworth1.
Abstract
AIM: To compare the safety protocols and operative outcomes of women undergoing laparoscopic-assisted myomectomy (LAM) by the same surgeons at a freestanding ambulatory surgery center (ASC) versus a hospital outpatient setting.Entities:
Keywords: ambulatory surgery center; laparoscopic; leiomyoma; ligation; myomectomy
Mesh:
Year: 2020 PMID: 31997510 PMCID: PMC7065249 DOI: 10.1111/jog.14197
Source DB: PubMed Journal: J Obstet Gynaecol Res ISSN: 1341-8076 Impact factor: 1.730
Patient characteristics
| ASC | Hospital |
| |
|---|---|---|---|
|
|
| ||
| Age group, | 0.7093 | ||
| <30 | 51 (8.6) | 28 (12.2) | |
| 30–39 | 349 (59.4) | 128 (55.9) | |
| 40–49 | 181 (30.8) | 69 (30.1%) | |
| 50–59 | 6 (1.0) | 4 (1.8) | |
| Race, | <0.0001 | ||
| White | 115 (19.6%) | 28 (12.3%) | |
| Black | 301 (51.2%) | 175 (76.8%) | |
| Other | 77 (13.1%) | 24 (10.5%) | |
| Unknown | 95 (16.2%) | 1 (0.4%) | |
| Number of previous myomectomies, | 0.2911 | ||
| None | 510 (86.7%) | 188 (82.5%) | |
| 1 | 71 (12.1%) | 36 (15.8%) | |
| 2 or more | 7 (1.2%) | 4 (1.8%) | |
| Number of previous abdominal surgeries, | 0.3217 | ||
| None | 355 (60.4%) | 129 (56.6%) | |
| 1 | 170 (28.9%) | 77 (33.8%) | |
| 2 | 39 (6.6%) | 17 (7.5%) | |
| 2 or more | 24 (4.1%) | 5 (2.2%) | |
| Number of comorbidities, | 0.4219 | ||
| None | 235 (40.0%) | 90 (39.5%) | |
| 1 | 200 (34.0%) | 76 (33.3%) | |
| 2 | 93 (15.8%) | 35 (15.4%) | |
| 3 or more | 60 (10.2%) | 27 (11.8%) |
ASC, ambulatory surgery center; BMI, body mass index; g, grams; kg, kilograms; kg/m2, kilogram per meter squared; n, number; SD, standard deviation; yrs, years.
Figure 1BMI by setting (%). () ASC, () Hospital
Figure 2Aggregate fibroid weight by setting (%). () ASC, () Hospital
Operative outcomes (unadjusted analysis)
| Setting | |||||
|---|---|---|---|---|---|
| ASC | Hospital |
| |||
|
| Mean (SD) |
| Mean (SD) | ||
| Estimated blood loss (mL) | 582 | 199.8 (227.2) | 227 | 265.0 (370.5) | 0.3218 |
| Length of stay (days) | 588 | 0.0 (0.0, 0.0) | 228 | 0.5 (1.0) | 0.9753 |
| Total surgery time (min) | 579 | 69.9 (26.3) | 226 | 81.3 (29.0) | <0.0001 |
| Number of ports | 573 | 2.2 (0.5) | 223 | 2.4 (0.9) | 0.0058 |
Operative outcomes (adjusted analysis)†
| Setting | |||
|---|---|---|---|
| ASC | Hospital |
| |
|
|
| ||
| Estimated blood loss (mL) ‐ adj. medians (95% CI) | 153.3 (139.0–167.6) | 147.2 (122.2–172.2) | 0.6948 |
| Operative time (min) ‐ adj. medians (95% CI) | 67.8 (65.5–70.1) | 80.0 (76.0–84.0) | <0.0001 |
| Number of ports ‐ adj. counts (95% CI) | 2.2 (2.1–2.4) | 2.4 (2.2–2.6) | 0.2912 |
| Intra‐op complications, % (95% CI) | 3.4 (1.8–5.0) | 4.9 (1.7–8.1) | 0.4430 |
| Post‐op complications, % (95% CI) | 4.9 (3.1–6.7) | 5.9 (2.6–9.1) | 0.6288 |
| Blood transfusions, % (95% CI) | 2.0 (0.8–3.2) | 6.5 (3.0–10.1) | 0.0247 |
Adjusted for age, race, number of previous surgeries, body mass index, number of comorbidities, number of additional procedures, fibroid weight, number of previous myomectomies and uterine artery ligation/occlusion.
Adj, adjusted; ASC, ambulatory surgery center; CI, confidence interval; intra‐op, intraoperative; min, minutes; mL, milliliter; post‐op, postoperative.
Most common complications
| Complications | Setting | |
|---|---|---|
| ASC | Hospital | |
|
|
| |
| Intraoperative | ||
| Intraoperative hemorrhage (EBL > 1000 mL) | 9 (1.5) | 6 (2.6) |
| Blood transfusion | N/A | 5 (2.2) |
| Bowel injury | 5 (0.8) | 2 (0.9) |
| Conversion to laparotomy | 0 (0.0) | 2 (0.9) |
| Uterine artery laceration | 2 (0.3) | 1 (0.4) |
| Bladder injury | 1 (0.2) | 0 (0.0) |
| Postoperative | ||
| Blood transfusion | 10 (1.7) | 20 (8.8) |
| Fever | 0 (0.0) | 3 (1.3) |
| Intra‐abdominal bleeding | 1 (0.2) | 3 (0.3) |
| Ileus/small bowel obstruction | 0 (0.0) | 2 (0.9) |
| Abdominal wall hematoma | 1 (0.2) | 2 (0.9) |
| Emergency department for abdominal pain | 6 (1.0) | 1 (0.4) |
| Shortness of breath, chest pain | 0 (0.0) | 1 (0.4) |
| Pelvic fluid collection (drained) | 0 (0.0) | 1 (0.4) |
| Syncope | 1 (0.2) | 1 (0.4) |
| Incisional bleeding | 2 (0.3) | 1 (0.3) |
| Hypoxia | 0 (0.0) | 1 (0.4) |
| Nausea/vomiting | 2 (0.3) | 0 (0.0) |
| Pelvic abscess | 1 (0.2) | 0 (0.0) |
| Hemothorax | 1 (0.2) | 0 (0.0) |
Includes multiple intraoperative complications as dictated in operative notes, but counted as one event in statistical analysis.
Safety protocols
| Safety standards | Setting | |
|---|---|---|
| ASC | Hospital | |
| Preoperative |
(1) Hemoglobin cut‐off of 9.0 g/dL. (2) I‐STAT used just prior to surgery on the day of surgery. (3) LAM cases are only scheduled as morning cases to allow for ample observation and recovery time. |
(1) Blood count from within 30 days suffices. (2) Hemoglobin cut‐off of 7.5 g/dL. (3) No limitations in timing of scheduling LAM cases. |
| Intraoperative |
(1) No blood transfusion capability. (2) Transfer to contracted hospitals if blood transfusion required. (3) Aseptic techniques, infection control and surgical sterility procedures are the same as the hospital setting. | (1) Blood transfusion available. |
| Postoperative |
(1) 1:1 nurse/patient ratio (2) 23 h observation is available at ASC. (3) Thromboprophylaxis follows the same protocol as the hospital except high risk patients may go home with portable SCDs. (4) Travel patients required to stay in hotel near ASC and return for follow up 2–3 days postop. (5) Local patients return for follow‐up 2 weeks post‐op. |
(1) >1:2 nurse/patient ratio. (2) Unlimited inpatient observation. (3) Patients with high risk for thrombosis must remain inpatient for SCD use. (4) Patients return for office follow‐up 2 weeks post‐op. |