Hysterectomy ranks among the most common gynecologic operations, with more than 600,000 procedures performed each year in the United States.1,2 The advent of laparoscopic techniques has greatly affected the approach to hysterectomy. With the current widespread use of laparoscopic surgery, we were compelled to evaluate the optimal approach to hysterectomy.
Myriad studies have evaluated hysterectomy outcomes. A 2002 meta-analysis found a significantly lower overall risk of complications with laparoscopic hysterectomy compared with laparotomy.3 Compared with vaginal hysterectomy, the laparoscopic approach provides better visualization of the peritoneal cavity, improving adhesiolysis or adnexectomy.4 These benefits are juxtaposed with potentially longer operative times and increased costs.4–7
Laparoscopic hysterectomy can be further subdivided into total laparoscopic hysterectomy and laparoscopically assisted vaginal hysterectomy (LAVH) techniques. These distinct approaches may confer different outcomes; however, studies evaluating these approaches have yielded inconsistent results.5,8–13 Although these studies provide valuable information, the majority have relied on data from a single high-volume institution with small sample sizes, limiting the value of their findings. This is of particular concern with such technically challenging laparoscopic procedures, which have demonstrated a considerable dependence on surgeon skill.14,15 Multicentered studies are able to moderate differences across institutions, expertise, and geographical regions to provide a more accurate analysis of the procedural risk profiles.
The American College of Surgeons (ACS) National Surgical Quality Improvement Program aims to improve surgical outcomes and collects data from more than 250 institutions across the nation. The objective of this study was to identify preoperative risk factors and compare outcomes of total laparoscopic hysterectomy and LAVH.
MATERIALS AND METHODS
An analysis was performed using the ACS National Surgical Quality Improvement Program data from 2006 to 2010. Data collection methods for the National Surgical Quality Improvement Program registry previously have been described in detail.16,17 In brief, patient demographics, comorbidities, preoperative laboratory values, and perioperative details are collected. Postoperative outcomes are tracked for 30 days after the primary operation. High-quality data are ensured by routine auditing and the use of specially trained surgical nurses to record patient variables. A random 8-day sampling method is used to ensure a diverse range of surgical procedures are captured. Deidentified patient information is freely available to all institutional members who comply with the ACS National Surgical Quality Improvement Program Data Use Agreement. The Data Use Agreement implements the protections afforded by the Health Insurance Portability and Accountability Act of 1996 and the ACS National Surgical Quality Improvement Program Hospital Participation Agreement.
To identify patients undergoing laparoscopic hysterectomy, the National Surgical Quality Improvement Program registry was queried using the primary Current Procedural Terminology codes pertaining to total laparoscopic hysterectomy (58570-58573) and LAVH (58550, 58552-58554). According to the Current Procedural Terminology codes of the American Medical Association, a total laparoscopic hysterectomy was defined as a laparoscopic total hysterectomy, with or without removal of tubes, ovaries, or both. Likewise, LAVH was defined as a laparoscopic operation with vaginal hysterectomy, with or without removal of tubes, ovaries, or both. Patients with codes for multiple hysterectomy types were excluded.
Primary outcomes of interest were overall morbidity, wound complications, medical complications, and reoperations within 30 days. Overall morbidity was defined as the presence of one or more of the following complications: superficial, deep, and organ or space surgical site infections; wound dehiscence; deep vein thrombosis; pulmonary embolism; unplanned reintubation; ventilator dependence for more than 48 hours; renal insufficiency; acute renal failure; coma; stroke; cardiac arrest; myocardial infarction; peripheral nerve injury; pneumonia, urinary tract infection; bleeding requiring transfusion; and sepsis or septic shock. Wound complications consisted of superficial, deep, and organ or space surgical site infection and wound dehiscence. Importantly, infections involving any part of the anatomy that was opened or manipulated during the operation are recorded. Medical complications consisted of deep vein thrombosis, pulmonary embolism, unplanned reintubation, ventilator dependence for more than 48 hours, renal insufficiency, acute renal failure, coma, stroke, cardiac arrest, myocardial infarction, peripheral nerve injury, pneumonia, urinary tract infection, bleeding requiring transfusion, and sepsis or septic shock. All outcomes were tracked for 30 days postoperatively and used as defined in the National Surgical Quality Improvement Program user guide.16
Variables for risk adjustment included patient demographics, comorbidities, and operative factors. Patient demographics included age, body mass index (BMI, calculated as weight (kg)/[height (m)]2), race, smoking (defined as active smoking during the year before the index operation), steroid use, radiotherapy within 90 days of the operation, chemotherapy within 30 days of the operation, and previous operations within 30 days. Comorbidities of interest included diabetes, dyspnea, hypertension, chronic obstructive pulmonary disorder, congestive heart failure, bleeding disorders, previous percutaneous coronary intervention or cardiac surgery, and previous stroke or transient ischemic attack (TIA). Operative factors used in risk adjustment analyses included the type of hysterectomy (LAVH or total laparoscopic hysterectomy) and total operative time. Additionally, the sums of the relative value units for additional procedures were used to adjust for the added complexity and risk, as has been described previously.18,19
Descriptive statistics were calculated for the study population and complication profiles were computed using Pearson χ2 or Fisher exact tests for categorical variables, and independent t tests were used for continuous variables. Multivariable regression models were used to control for potential confounding variables and to identify independent risk factors for postoperative complications. This analysis was used to quantify the association between predictors and overall morbidity, wound complications, medical complications, and reoperations. Preoperative variables underwent univariable screening using Pearson χ2 and independent t tests for categorical and continuous variables, respectively. Factors with a significance value of P<.2 were included in the regression models. The method of hysterectomy was included in regression models regardless of significance, with laparoscopic-assisted vaginal hysterectomy serving as the reference group. To improve model precision, variables with fewer than 10 events per variable were excluded.20 Hosmer-Lemmeshow and C-statistics were computed to assess model goodness-of-fit and the ability to discriminate between events and nonevents, respectively.21
A total of 6,190 patients underwent minimally invasive hysterectomy during the study period, of whom 4,107 (66.3%) underwent LAVH and 2,083 (33.7%) underwent total laparoscopic hysterectomy. A comparison of patient characteristics is summarized in Table 1. There were no significant differences in the distribution of age or clinical characteristics among cohorts. There were no significant differences in the distribution of patient comorbidities, except for hypertension, which was elevated in the total laparoscopic hysterectomy cohort (27.8% compared with 24.2%; P=.002). An elevated BMI was observed in the total laparoscopic hysterectomy cohort (30.5 compared with 29.8; P<.001) and an unequal distribution of race was noted (Table 1).
Overall morbidity was low and did not differ significantly among cohorts, with LAVH and total laparoscopic hysterectomy patients experiencing morbidity rates of 7.05% and 6.3%, respectively (P=.353). Few wound complications were observed, with overall infection rates of 2.2% and 1.8% for LAVH and total laparoscopic hysterectomy, respectively (P=.227). Overall medical complications occurred in less than 5.5% of patients for all cohorts and did not differ significantly (Table 2). Reoperations within 30 days and length of postoperative stay did not differ significantly among procedure types. Patients undergoing total laparoscopic hysterectomy experienced significantly longer operations, averaging 2.66 hours compared with 2.20 hours for LAVH patients (P<.001).
When adjusting for potential confounders, no significant association between the hysterectomy technique and 30-day morbidity was observed (Table 3). However, smoking, previous stroke or TIA, and increased operative time were found to be significant independent risk factors in the development of postoperative complications. Smokers were 1.35-times as likely to experience 30-day morbidity compared with nonsmokers (P=.011). Patients with a history of stroke or TIA were nearly twice as likely to have development of one or more postoperative complications (odds ratio [OR] 1.94, 95% confidence interval [CI] 1.03–3.65; P=.041). Each additional hour of surgery, independent of surgical technique, was found to confer a 22% increase in risk (P<.001). Outpatient procedures and elderly patients were associated with fewer complications (Table 3). Interestingly, patient BMI was not significantly associated with morbidity.
Examination of wound complications found operative length to be the only significant independent risk factor (Table 4). Each subsequent hour of operative time conferred an 18% increase in risk, irrespective of surgical technique (OR 1.18, 95% CI 1.04–1.34; P=.009). No association was observed between surgical approach and wound complications. Again, patients undergoing hysterectomy in an outpatient setting were less likely to experience wound complications (OR 0.670, 95% CI 0.45–0.99; P=.043).
Independent risk factors associated with medical complications included smoking, previous stroke or TIA, and operative time (Table 5). The odds for development of a medical complication were 1.52-times and 2.23-times greater in patients who smoked or who had a previous stroke or TIA, respectively (P<.001 and P=.018). No association was observed between hysterectomy technique and medical complications. Again, outpatient procedures were associated with fewer medical complications (OR 0.63, 95% CI 0.49–0.81; P<.001).
Regression analysis for reoperations found no association between surgical technique and reoperation rates (Table 6). However, each additional hour of operative time increased the risk of reoperation by 23% (P<.001).
The lack of significance found with the Hosmer-Lemmeshow goodness-of-fit tests represents an adequate fit for all regression models (Tables 3–6). The C-statistic was less than the desired threshold of 0.7 for all regression models, which may reflect a low discriminatory power or perhaps low patient-level variability.
Increased utilization of laparoscopic approaches in hysterectomies has prompted a critical evaluation of the procedure-specific outcomes. Previous studies, including prospective randomized control trials, have attempted to quantify the respective outcomes for total laparoscopic hysterectomy and LAVH techniques but generally have been limited by their single institution perspective and small sample sizes.5,8–13 This current analysis of more than 6,000 laparoscopic hysterectomies provides the largest multicenter series to date describing 30-day outcomes and evaluating the clinical implications of risk factors.
A low complication rate was observed in both total laparoscopic hysterectomy and LAVH methods, supporting the relative safety of these procedures (6.3% and 7.0%, respectively).8,11 In a univariable analysis, no significant difference was observed in overall morbidity, wound complications, medical complications, and reoperations among patients undergoing total laparoscopic hysterectomy or LAVH. This finding was corroborated with logistic regression analyses, which demonstrated no association with surgical approach and adverse events after adjusting for potential confounding factors. This is in agreement with previous analyses.8,11,12
The mean operating times in our series were 132 minutes and 160 minutes for LAVH and total laparoscopic hysterectomy, respectively (P<.001). These times are consistent with previous reports, which also demonstrated reduced operative times in LAVH procedures.4,10,12,22 However, operative length has demonstrated a strong dependence on surgeon skill. Consequently, studies evaluating outcomes from a single surgeon or institution are unable to provide a complete investigation of operative times. Our study utilized data from a random sampling of surgeons from numerous medical institutions, enabling a more representative analysis of operative times in general practice.
Interestingly, regression analysis identified operative time as an independent predictor of postoperative morbidity and reoperation, irrespective of surgical approach. Although increased operative times have long-been speculated to confer additional risk, the association between increased operative time and morbidity may simply indicate that more technically complex cases require a greater amount of time to complete and predispose patients to deleterious outcomes. An additional consideration is the time that patients are placed in Trendelenburg position that is required to complete laparoscopic hysterectomies. Further analysis of this association is needed for clarification.
It is well-established that obesity confers significant risk for postoperative surgical morbidity.23–25 Although once considered a contraindication to laparoscopic surgery, the effect of obesity in laparoscopic hysterectomy outcomes does not appear to be as significant as once believed, with numerous studies reporting comparable complication rates in obese and nonobese individuals.26–28 Our analysis supports these findings, revealing no significant association observed between BMI and postoperative morbidity. Because of technical obstacles and potential underlying medical comorbidities precluding adequate Trendelenburg positioning, obese patients are at increased risk for conversion to laparotomy.11,26 As a result of the reporting protocols associated with the National Surgical Quality Improvement Program registry, our analysis was unable to accurately capture conversion rates.
The main limitation of this study is its retrospective nature. Additionally, an incomplete capture of procedure-specific outcomes, such as urinary tract injury, may have resulted in an under-reporting of complications. Because of National Surgical Quality Improvement Program protocols, we were unable to accurately track conversion rates and, as such, only procedures successfully completed using a single surgical approach were analyzed. Although the National Surgical Quality Improvement Program registry is well-suited for an analysis of short-term complications, a more thorough investigation of longer-term outcomes, such as adhesive disease and pelvic abscesses, would further clarify total laparoscopic hysterectomy and LAVH outcomes. Additional observations of minimally invasive gynecologic hysterectomies also should include the laparoscopic supracervical hysterectomy in comparison with the total laparoscopic hysterectomy and LAVH.
1. Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol 2007;110:1091–5.
2. Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990-1997. Obstet Gynecol 2002;99:229–34.
3. Chapron C, Fauconnier A, Goffinet F, Breart G, Dubuisson JB. Laparoscopic surgery is not inherently dangerous for patients presenting with benign gynaecologic pathology. Results of a meta-analysis. Hum Reprod 2002;17:1334–42.
4. Ikhena SE, Oni M, Naftalin NJ, Konje JC. The effect of the learning curve on the duration and peri-operative complications of laparoscopically assisted vaginal hysterectomy. Acta Obstet Gynecol Scand 1999;78:632–5.
5. Drahonovsky J, Haakova L, Otcenasek M, Krofta L, Kucera E, Feyereistl J. A prospective randomized comparison of vaginal hysterectomy, laparoscopically assisted vaginal hysterectomy, and total laparoscopic hysterectomy in women with benign uterine disease. Eur J Obstet Gynecol Reprod Biol 2010;148:172–6.
6. Makinen J, Johansson J, Tomas C, Tomas E, Heinonen PK, Laatikainen T, et al.. Morbidity of 10 110 hysterectomies by type of approach. Hum Reprod 2001;16:1473–8.
7. Jonsdottir GM, Jorgensen S, Cohen SL, Wright KN, Shah NT, Chavan N, et al.. Increasing minimally invasive hysterectomy: effect on cost and complications. Obstet Gynecol 2011;117:1142–9.
8. Ghezzi F, Cromi A, Bergamini V, Uccella S, Beretta P, Franchi M, et al.. Laparoscopic-assisted vaginal hysterectomy versus total laparoscopic hysterectomy for the management of endometrial cancer: a randomized clinical trial. J Minim Invasive Gynecol 2006;13:114–20.
9. Holub Z, Jabor A, Sprongl L, Fischlova D, Urbanek S. Clinical outcome, inflammatory response and tissue trauma in total laparoscopic hysterectomy: comparison to laparoscopically-assisted vaginal hysterectomy. Ceska Gynekol 2002;67:315–20.
10. Kim DH, Bae DH, Hur M, Kim SH. Comparison of classic intrafascial supracervical hysterectomy with total laparoscopic and laparoscopic-assisted vaginal hysterectomy. J Am Assoc Gynecol Laparosc 1998;5:253–60.
11. Fader AN, Michener CM, Frasure HE, Giannois N, Belinson JL, Zanotti KM. Total laparoscopic hysterectomy versus laparoscopic-assisted vaginal hysterectomy in endometrial cancer: surgical and survival outcomes. J Minim Invasive Gynecol 2009;16:333–9.
12. Long CY, Fang JH, Chen WC, Su JH, Hsu SC. Comparison of total laparoscopic hysterectomy and laparoscopically assisted vaginal hysterectomy. Gynecol Obstet Invest 2002;53:214–9.
13. Shin JW, Lee HH, Lee SP, Park CY. Total laparoscopic hysterectomy and laparoscopy-assisted vaginal hysterectomy. JSLS 2011;15:218–21.
14. Hwang JH, Yoo HJ, Joo J, Kim S, Lim MC, Song YJ, et al.. Learning curve analysis of laparoscopic radical hysterectomy and lymph node dissection in early cervical cancer. Eur J Obstet Gynecol Reprod Biol 2012;163:219–23.
15. Paek J, Kim SQ, Lee SH, Lee M, Yim GW, Nam EJ, et al.. Learning curve and surgical outcome for single-port access total laparoscopic hysterectomy in 100 consecutive cases. Gynecol Obstet Invest 2001;72:227–33.
16. Song T, Kim TJ, Lee YY, Choi CH, Lee JW, Kim BG, et al.. What is the learning curve for single-port access laparoscopic-assisted vaginal hysterectomy? Eur J Obstet Gynecol Reprod Biol 2011;158:93–6.
17. Birkmeyer JD, Shahian DM, Dimick JB, Finlayson SR, FLum DR, Ko CY, et al.. Blueprint for a new American College of Surgeons: National Surgical Quality Improvement Program. J Am Coll Surg 2008;207:777–82.
18. Henderson WG, Daley J. Design and statistical methodology of the National Surgical Quality Improvement Program: why is it what it is? Am J Surg 2009;198:S19–S27.
19. Dillon P, Hammermeister K, Morrato, Kempe A, Oldham K, Moss L, et al.. Developing a NSQIP module to measure outcomes in children's surgical care: opportunity and challenge. Semin Pediatr Surg 2008;17;131–40.
20. Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR. A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol 1996;49:1373–9.
21. Harrell FE Jr, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med 1996;15:361–87.
22. Chapron CM, Dubuisson JB, Ansquer Y. Is total laparoscopic hysterectomy a safe surgical procedure? Hum Reprod 1996;11:2422–4.
23. Choban PS, Flancbaum L. The impact of obesity on surgical outcomes: a review. J Am Coll Surg 1997;185:593–603.
24. Calle EE, Thun MJ, Petrelli JM, Rodriguez C, Heath CW Jr. Body-mass index and mortality in a prospective cohort of U.S. adults. N Engl J Med 1999;341:1097–105.
25. Byrne TK. Complications of surgery for obesity. Surg Clin North Am 2001;81:1181–93.
26. Heinberg EM, Crawford BL III, Weitzen SH, Bonilla DJ. Total laparoscopic hysterectomy in obese versus nonobese patients. Obstet Gynecol 2004;103:674–80.
27. Shen CC, Hsu TY, Huang FJ, Huang EY, Huang HW, Chang HY, et al.. Laparoscopic-assisted vaginal hysterectomy in women of all weights and the effects of weight on complications. J Am Assoc Gynecol Laparosc 2002;9:468–73.
28. O'Hanlan KA, Lopez L, Dibble SL, Garnier AC, Huang GS, Leuchtenberger M. Total laparoscopic hysterectomy: body mass index and outcomes. Obstet Gynecol 2003;102:1384–92.