Minilaparotomy vs Laparoscopic Hysterectomy: Comparison of Length of Hospital Stay

Accepted Manuscript Minilaparotomy versus laparoscopic hysterectomy: A comparison of length of hospital stay Misa Perron-Burdick, MD Amanda Calhoun, MD MPH Dennis Idowu, MD Alice Pressman, PhD MS Eve Zaritsky, MD PII:

S1553-4650(14)00032-6

DOI:

10.1016/j.jmig.2013.12.125

Reference:

JMIG 2224

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 22 August 2013 Revised Date:

6 December 2013

Accepted Date: 7 December 2013

Please cite this article as: Perron-Burdick M, Calhoun ; Dennis, Idowu ; Alice Pressman A, Zaritsky E, Minilaparotomy versus laparoscopic hysterectomy: A comparison of length of hospital stay, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/j.jmig.2013.12.125. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT Perron-Burdick Minilaparotomy versus laparoscopic hysterectomy: A comparison of length of

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hospital stay

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TITLE:

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ACCEPTED MANUSCRIPT

Minilaparotomy versus laparoscopic hysterectomy: A comparison of length of hospital stay Article Type: Original Article

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Misa Perron-Burdick, MD*; Amanda Calhoun, MD MPH; Dennis Idowu, MD; Alice Pressman, PhD MS; Eve Zaritsky, MD San Francisco Veterans Affairs Medical Center, San Francisco, California (all authors). Keywords: hysterectomy; laparoscopy; minilaparotomy; laparotomy; hospital stay; length of stay

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*Corresponding Author

ACCEPTED MANUSCRIPT Perron-Burdick ABSTRACT Study Objective: To compare length of hospital stay for minilaparotomy versus laparoscopic

Design: Retrospective cohort study. Design Classification: Canadian Task Force classification II-2.

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hysterectomy.

Setting: Kaiser Permanente Northern California, a large integrated health care delivery system.

for benign indications from June 2009 through January 2010.

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Patients: Women over the age of 18 undergoing laparoscopic or minilaparotomy hysterectomy

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Intervention: Hysterectomy by minilaparotomy or laparoscopy.

Measurements and Main Result: Chart reviews were performed for outcomes of interest including length of stay and surgical and demographic characteristics. Parametric and nonparametric analyses techniques are used to compare the two groups. The study is powered to

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detect a difference of 8 hours in length of stay. Two hundred and sixty-three cases were identified as hysterectomy by minilaparotomy (n=100) or laparoscopy (n=163). The laparoscopic group demonstrated a significantly shorter length of stay (19±14 hours vs. 42±20,

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p<.001) and less blood loss (126±140 mL compared to 241±238 mL, P<.001). The minilaparotomy group experienced a shorter procedure time (113±47 min compared to 197±124

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min, p<.001). There is no difference between the groups with respect to patient morbidity including intraoperative and postoperative complications, emergency visits, readmissions, or reoperations.

Conclusion: Compared to minilaparotomy, laparoscopic hysterectomy is associated with shorter length of hospital stay, longer operating times, and no increased patient morbidity.

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ACCEPTED MANUSCRIPT Perron-Burdick INTRODUCTION Hysterectomy is among the most frequently performed gynecologic surgeries in the United States. Prolonged hospital stay and delayed return to productivity are major

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considerations for hospitals, insurers, and patients. Minimally invasive techniques including the vaginal, laparoscopic, and minilaparotomy approaches have demonstrated shorter hospital stays, quicker return to normal activity, and improved quality of life compared to hysterectomy

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performed by traditional laparotomy.1,2 While vaginal hysterectomy is considered the preferred approach due to cost and low complication rate, it may not be feasible in cases of large uteri,

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reduced vaginal access, extensive pelvic scarring, or in patients who desire to retain their cervix. Laparoscopic hysterectomy, in turn, has been associated with high costs, long operative times, and increased complications when compared to the vaginal or laparotomy route.3 Minilaparotomy has long been considered a feasible and cost-effective alternative to

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laparoscopy in gynecologic surgery.4 Small studies comparing minilaparotomy to laparoscopy for non-hysterectomy gynecologic surgery suggest that minilaparotomy may be associated with decreased operative time and overall cost when compared to laparoscopy, however this may be

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at the risk of increased postoperative pain, longer hospitalization, and delayed return to activities.5-7 One study comparing minilaparotomy to laparoscopic-assisted vaginal

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hysterectomy (LAVH) reported more complications and increased postoperative pain the minilaparotomy group.8

Despite a growing body of research aimed at determining the optimal route of minimally invasive hysterectomy, there is a paucity of data comparing minilaparotomy to laparoscopic hysterectomy. The purpose of this study is to examine the differences between minilaparotomy and laparoscopic hysterectomy in terms of length of hospital stay and patient morbidity.

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ACCEPTED MANUSCRIPT Perron-Burdick

MATERIALS AND METHODS The Kaiser Permanente Northern California Institutional Review Board for the protection

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of human participants approved this study. Kaiser Permanente Northern California is a large, integrated healthcare delivery system that provides comprehensive medical care for more than 35% of insured adults in the region. The Kaiser Permanente Northern California membership of

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approximately 3.2 million has been shown to have substantial racial and ethnic diversity and highly representative of the surrounding local and statewide population.9,10

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This is a retrospective cohort study. Current Procedural Terminology (CPT4) and International Classification of Diseases, 9th Revision (ICD9) codes were used to identify patients at least 18 years old who underwent hysterectomy by minilaparotomy or laparoscopy for benign indications from June 2009 through January 2010. Patients were confirmed to be Kaiser

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Permanente members for 3 months before and after surgery. The charts were randomly ordered and serially reviewed for eligibility until at least 100 patients were identified for each group. Surgeries that included associated or facilitative procedures such as lysis of adhesions, adnexal

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procedures, or dilation and curettage are included. Surgeries performed for malignancy or that included ancillary procedures such as pelvic reconstruction, appendectomy, cholecystectomy, or

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hernia repair are excluded. Laparoscopic-assisted vaginal hysterectomy (LAVH) as defined by ligation of the uterine arteries from the blinded vaginal approach is not included as it is considered to be a different procedure from laparoscopic hysterectomy with a distinct risk profile. Patients were followed for 3 months after surgery. The primary outcome of this study is length of hospital stay as identified according to admission and discharge billing records. Length of stay is defined as patient arrival to the pre-

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ACCEPTED MANUSCRIPT Perron-Burdick surgical area to discharge from the post anesthesia care unit or hospital floor. Secondary outcomes include intraoperative complications, postoperative complications, readmissions, reoperations, and visits to the emergency department. Patients were followed for 3 months

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postoperatively. Patient demographic and surgical characteristics are also examined. Electronic medical records were reviewed to assess for study eligibility, ensure accuracy of coding, and perform data extraction.

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A hysterectomy is considered to be minilaparotomy if the transverse skin incision is less than or equal to 8cm.4 Other characteristics typical of minilaparotomy surgery may or may not

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be present, including vertical fascia incision, intrafascial injection of lidocaine, and perioperative administration of dexamethasone and ketorolac. Generalist obstetrician gynecologists, a few of whom had completed laparoscopic fellowship, performed the laparoscopic hysterectomies in this study. Generalist obstetrician gynecologists also performed the minilaparotomy hysterectomies.

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Many facilities had or were affiliated with residency training programs in obstetrics and gynecology and thus residents routinely participated in both minilaparotomy and laparoscopy cases. Hysterectomy type was selected by the surgeon after a standard discussion of risks,

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benefits, and alternatives with the patient. All laparoscopic hysterectomies were performed using traditional multiple-port laparoscopy. No single-port or robotic surgeries are included.

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Surgeries varied by uterine manipulator, number of port sites, cautery or vessel sealing instrument, morcellation technique, vaginal versus laparoscopic cuff closure, and suture material. Since laparoscopic hysterectomy was a new procedure during the time of this study, cystoscopy was frequently performed upon completion of each case whereas this was not routinely done for minilaparotomy.

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ACCEPTED MANUSCRIPT Perron-Burdick Parametric and non-parametric analyses techniques are used to compare the two groups with respect to length of stay and other outcomes. Student’s t-test is used for comparison of means and chi-square and Fisher’s exact tests are used for comparisons of frequency. The

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standard p-value < .05 is considered statistically significant. The study is designed with 80% power to detect a difference of 8 hours in length of stay at the 5% level of significance. Ninetyfive patients are required in each group to achieve this level of power. All statistical analyses are

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conducted using SAS 9.1.

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RESULTS

Five hundred and seventy-six charts were reviewed to yield 100 minilaparotomy and 163 laparoscopic hysterectomy patients. The remaining cases were most commonly excluded for failing to meet surgical criteria for minilaparotomy with an incision >8 cm or for being LAVH

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rather than hysterectomy done entirely by the laparoscopic approach. There is no difference in age, obesity, or overweight between the groups (Table 1). Patients have a mean age of 45 and nearly half are obese with a body mass index (BMI) > 30. Most patients have had at least one

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prior abdominal surgery. While the minilaparotomy group trended towards having a greater number of previous surgeries, this finding was not statistically significant.

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Procedure time is available for 150 and 97 patients of the laparoscopic and minilaparotomy groups, respectively, and estimated blood loss is available for 161 and 97 patients. The laparoscopic hysterectomy group has a longer procedure time and less blood loss compared to the laparoscopy group (Table 2). Uterine size is equal between the groups. There is no difference in intraoperative complications or blood transfusions. The laparoscopic hysterectomy group had 3 intraoperative complications including a bladder dome injury, a

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ACCEPTED MANUSCRIPT Perron-Burdick uterine artery injury converted to laparotomy, and one case of multiple vaginal and perineal lacerations requiring repair and a foley catheter. The minilaparotomy group had 1 intraoperative complication of a bladder dome injury.

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The laparoscopic hysterectomy group had a significantly shorter hospital stay compared to the minilaparotomy group (median 11 hours compared to 35 hours, P≤.0001). Whereas most laparoscopy patients were discharged home prior to 24 hours, the majority of minilaparotomy

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patients stayed in the hospital for greater than 24 hours (92% vs. 35%, p<.001).

There is no statistically significant difference between the groups with respect to

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postoperative complications, emergency visits, readmissions, and reoperations (Table 3). The laparoscopic group had 4 postoperative complications including an umbilical wound seroma, a vaginal cuff dehiscence, a broad ligament hematoma with sepsis, and a ureterovaginal fistula. The minilaparotomy group had 5 postoperative complications including a wound infection, two

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patients with postoperative anemia requiring transfusion, a cuff cellulitis, and a cuff abscess. Emergency visit diagnoses are summarized in Table 5. The minilaparotomy group had 3 readmissions for cuff cellulitis, cuff abscess, and symptomatic anemia requiring a blood

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transfusion. The laparoscopy group also had three readmissions for a broad ligament hematoma

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and sepsis, an abdominal wound seroma, and a cuff dehiscence requiring reoperation.

DISCUSSION

This is the first study to directly compare minilaparotomy with laparoscopic hysterectomy. Length of hospital stay was longer for minilaparotomy patients by 24 hours. Our results are consistent with prior research reporting shorter length of stay for myomectomy done by laparoscopy versus minilaparotomy. In 2010, Malzoni and colleagues reported an average

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ACCEPTED MANUSCRIPT Perron-Burdick hospital stay of 2.1 days for laparoscopic myomectomy compared to 3.1 days for minilaparotomy.11 Two additional studies of minilaparotomy versus laparoscopic myomectomy demonstrated similarly substantial differences in length of hospital stay.5,7 Our results can be

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attributed, in part, to the fact that same-day discharge after laparoscopy has been common practice at many Kaiser Permanente facilities since 2008 with approximately 60% of

laparoscopic hysterectomy patients discharged home within a few hours of surgery. The practice

undergoing uncomplicated laparoscopic hysterectomy.12

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of same-day discharge has been shown to be a safe and feasible practice for healthy patients

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Procedure times for both minilaparotomy and laparoscopy are longer than reported in previous studies.13-17 The reason for this difference may be related to the participation of resident trainees or a different patient population with larger uteri or increased number of previous abdominal surgeries. Our results demonstrated a substantially longer operative time for

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laparoscopic hysterectomy compared to minilaparotomy. This is consistent with one previous study that compared minilaparotomy to LAVH.8 Laparoscopic hysterectomy was a new procedure for many of our providers during the study period hence the longer procedure times

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may reflect of period of training for attending physicians as well as residents. Anecdotally, we have seen decreased surgical times and increased uterine sizes as physicians have become

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proficient in laparoscopic hysterectomy. While the laparoscopic hysterectomy group demonstrated less blood loss, it is unlikely that this difference of 115 ml is a clinically significant blood volume. The lack of difference between the groups with respect to age, BMI, surgical history, and uterine weight suggests that patients were candidates for either surgical approach. We suspect that the choice for minilaparotomy versus laparoscopy was guided by surgeon

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ACCEPTED MANUSCRIPT Perron-Burdick experience rather than patient factors as this study takes place during a period of time when laparoscopic hysterectomy was being adopted by some surgeons and not others. Our intraoperative and postoperative complications rates are comparable to the most

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recently published rates for minilaparotomy and laparoscopic hysterectomy.13,14,18 While the number of complications does not differ between the groups, our study was not powered to detect a difference and there may be a qualitative difference in the severity of complications.

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One study that directly compared complication rates in conventional laparotomy versus

laparoscopic hysterectomy reported more complications in the laparoscopic group.3 However,

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this study was published in 2004 when laparoscopic hysterectomy was a relatively new procedure to the generalist gynecology community. Complication rates are expected to decline over time with increased surgeon experience and ancillary staff training. There were also more emergency department visits in the laparoscopy group compared to the minilaparotomy group,

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specifically for pain and vaginal bleeding. This finding is not statistically significant however our study was not powered to detect a difference. The increased number of emergency may be related to the strict precautions regarding pain and bleeding given to laparoscopic hysterectomy

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patients discharged home the same day of surgery. Minilaparotomy patients may have had similar concerns but since they are more routinely admitted to the hospital after surgery they

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likely received more reassurance and patient education regarding normal postoperative pain and vaginal bleeding.

While cost was not directly available for our study population, a comparison of hysterectomy by laparotomy, LAVH, and vaginal hysterectomy in the Kaiser Northern California region has been previously published (Van Den Eeden 1998).19 Laparotomy was more expensive than LAVH ($9135 versus $8099) including preoperative, hospitalization, and

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ACCEPTED MANUSCRIPT Perron-Burdick postoperative costs. The generalizability of this cost assessment to our study is somewhat limited given the different surgical approaches (traditional laparotomy instead of minilaparotomy and LAVH instead of completely laparoscopic) but it suggests that open hysterectomy is more

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expensive than minimally invasive approaches within the Kaiser Permanente system. Although our study demonstrated a markedly increased length of stay for minilaparotomy compared to a small increase in operative time with laparoscopic hysterectomy, we did not measure operative

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costs and thus it is unclear if the difference translates to overall decreased hospital utilization or an improved cost profile. This is a direction for future research.

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The strength of this study lies in the thorough accounting of all cases. Kaiser Permanente is the sole provider to its members and uses electronic medical records for documentation of all patient encounters, procedures, medications, imaging, and laboratory tests that cover the entire Northern California service area. This study is also generalizable to a diverse surgeon

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population spread across multiple medical centers employing variable surgical techniques. There are limitations in this study. Despite the convenience and accuracy of electronic medical records, there were rare occasions in which variables of interest were not recorded. It is

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also possible that some patients presented to a non-Kaiser facility for postoperative care during the study period. However, substantial loss to follow-up is unlikely given the numerous Kaiser

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clinics and hospitals throughout the Northern California region. Additionally, institutions that do not practice same-day discharge after laparoscopic hysterectomy may not experience such a sizeable difference in length of stay between minilaparotomy and laparoscopic hysterectomy. We defined length of stay as time from admission to the preoperative unit to discharge from the postoperative unit and therefore any delays in the surgical schedule are included in total admitted time. However we expect surgical delays to be present equally in each group. Additional

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ACCEPTED MANUSCRIPT Perron-Burdick variables that may shed light on the complexity of this issue were also not collected, including surgical indication, postoperative medications, surgeon experience, and specific intraoperative techniques and findings. This study is also not powered to detect differences in patient

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comorbidities and while our patients were followed for 3 months postoperatively, it is possible that very long-term morbidities and visits were missed.

Our aim is to support the decision-making process for providers considering

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minilaparotomy versus laparoscopic hysterectomy. Hospital utility and patient safety are two important considerations when counseling surgical patients. We found that laparoscopic

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hysterectomy resulted in significantly decreased length of stay with no increased patient morbidity.

Minimally invasive hysterectomies are growing in importance and popularity. As the evidence accumulates that these procedures are safe and effective, further study is needed to

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elucidate which procedures are the most cost-effective and provide the greatest patient

REFERENCES

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satisfaction and improved quality of life.

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1. Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database of Systematic Reviews 2009, Issue 3. Art. No.: CD003677. DOI: 10.1002/ 14651858.CD003677.pub4. 2. Nieboer TE, Hendriks JCM, Bongers MY, Nierhout ME, Kluivers KB. Quality of life after laparoscopic and abdominal hysterectomy. Obstet Gynecol 2012;119:85-91.

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ACCEPTED MANUSCRIPT Perron-Burdick 3. Garry R, Fountain J, Mason S, Napp V, Brown J, Hawe J, et al. The eVALuate study: two parallel randomized trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ 2004;328:129-35.

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4. Benedetti-Panici, Maneschi F, Cutillo G, Scambia G, Congiu M, Mancuso S. Surgery by minilaparotomy in benign gynecologic disease. Obstet Gynecol 1996;87:456-9.

5. Alessandri F, Lijoi D, Mistrangelo E, Ferrero S, Ragni N. Randomized study of laparoscopic

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versus minilaprotomic myomectomy for uterine myomas. J Min Invasive Gynecol 2006;13(2):92-7.

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6. Rodgers AK, Goldberg JM, Hammel JP, Falcone T. Tubal anastomosis by robotic compared with outpatient minilaparotomy. Obstet Gynecol 2007;109:1375-80. 7. Cicinelli E, Tinelli R, Colafiglio G, Saliani N. Laparoscopy versus minilaparotomy in women with symptomatic uterine myomas: A prospective randomized study. J Min Invasive Gynecol

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2006;16(4):422-6.

8. Muzii L, Basile S, Zupi E, Marconi D, Zullo MA, Manci N, et al. Laparoscopic-assisted vaginal hysterectomy versus minilaparotomy hysterectomy: A prospective randomized,

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multicenter study. J Min Invasive Gynecol 2007;14(5):610-15. 9. Krieger N. Overcoming the absence of socioeconomic data in medical records: validation

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and application of a census-based methodology. Am J Public Health 1992;82(5):703-10. 10. Gordon NP. How Does the Adult Kaiser Permanente Membership in Northern California Compare with the Larger Community? Oakland, CA: Kaiser Permanente Division of Research; 2006 June. Available from: http://www.dor.kaiser.org/dor/mhsnet/public/kpnc_community.htm

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ACCEPTED MANUSCRIPT Perron-Burdick 11. Malzoni M, Tinelli R, Cosentino F, Iuzzolino D, Surico D, Reich H. Laparoscopy versus minilaparotomy in women with symptomatic uterine myomas: Short-term and fertility results. Fertil Steril;93:2368-73.

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12. Perron-Burdick M, Yamamoto M, Zaritsky E. Same-day discharge after laparoscopic hysterectomy. Obstet Gynecol 2011;1136-41.

13. Wallwiener M, et al. Laparoscopic supracervical hysterectomy versus total laparoscopic

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hysterectomy: An implementation study in 1952 patients with an analysis of risk factors for

Gynecol Obstet 2013; Jun 18.

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conversion to laparotomy and complications, and of procedure-specific re-operations. Arch

14. Grosse-Drieling D, Schlutius JC, Altgassen C, Kelling K, Theben J. Laparoscopic supracervical hysterectomy, a retrospective study of 1584 cases regarding intra- and perioperative complications. Arch Gynecol Obstet 2012;285(5):1391-6.

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15. Mahendru R, Malik S, Mittal A, Sekhon PK, Malik N, Mehendru TA. Minilaparotomy hysterectomy: A worthwhile alternative. J Obstet Gynaecol Res 2011;37(4):305-12. 16. Chalkoo M, Ahangar S, Durrani AM, Shah MJ, Habib R, Chalkoo S. Mini-lap hysterectomy

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revisited with new concepts and technical modifications. Int J Surg 2011;9(5):404-9. 17. Sharma JB, Wadwa L, Malhotra M, Arora R. Mini laparotomy versus conventional laparotomy

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for abdominal hysterectomy: A comparative study. Indian J Med Sci 2004;58:196-202. 18. Wright JD, et al. Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA 2013;309(7):689-98. 19. Van den Eeden SK, Glasser M, Mathias SD, Colwell HH, Pasta DJ, Kunz K. Quality of life, health care utilization, and costs among women undergoing hysterectomy in a managed-care setting. Am J Obstet Gynecol 1998;178:91-110.

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ACCEPTED MANUSCRIPT Perron-Burdick

Table 1. Patient characteristics Laparoscopy (N=163) 44.7 ± 7.5 29.7 ± 5.9 68 (42) 80 (49)

Data are mean ± SD or n (%).

Data are mean ± SD or n (%).

Table 3. Patient morbidities

TOTAL

0.059

P-value <.001 0.112 <.001 0.291

Laparoscopy (N=163) 18 (11.0) 3 (1.8)

P-value

5 (5.0)

4 (2.5)

.281

3 (3.0) 0

3 (1.8) 1 (0.6)

.677 1.0

15 (15.0)

28 (17.2)

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Minilaparotomy (N=100) 6 (6.0) 1 (1.0)

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Emergency visits Intraoperative complications Postoperative complications Readmission Reoperation

Laparoscopy (N=163) 197 ± 124 245 ± 204 126 ± 140 3 (2)

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Procedure time (min) Uterine weight (g) Blood loss (ml) Transfusion

Minilaparotomy (N=100) 113 ± 47 301 ± 313 241 ± 238 4 (4)

0.447 0.659

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Table 2. Surgical characteristics

P-value

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Age (y) BMI (kg/m2) BMI higher than 30 Previous surgery*

Minilaparotomy (N=100) 45.4 ± 7.3 29.4 ± 5.8 49 (49) 61 (61)

.265 1.0

Data are n (%).

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Table 4. Emergency visits

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Pain Vaginal bleeding Wound problem UTI Colitis Vaginal cuff cellulitis Fistula Anemia/blood transfusion Urinary retention Pulmonary embolism Sepsis Total

Laparoscopy (N=163) 5 4 2 2 2 -1 -1 -1 18 (11%)

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Minilaparotomy (N=100) 1 -2 --1 -1 -1 -6 (6%)

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Data are in frequency (percent).

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