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Prospective Evaluation of Quality of Life in Total versus Supracervical Laparoscopic Hysterectomy
Original Article
Prospective Evaluation of Quality of Life in Total versus Supracervical Laparoscopic Hysterectomy Jon I. Einarsson, MD, MPH*, Yoko Suzuki, MD, MPH, Thomas T. Vellinga, Gudrun M. Jonsdottir, Magnus K. Magnusson, MD, Rie Maurer, Honami Yoshida, MD, PhD, MPH, and Brian Walsh, MD From Brigham and Women’s Hospital, Boston, Massachusetts (all authors) .
ABSTRACT Study Objective: To evaluate and compare recovery times and quality of life (QOL) in patients undergoing a total laparoscopic hysterectomy (TLH) and laparoscopic supracervical hysterectomy (LSH). Design: Patients underwent either a TLH or LSH. After surgery, patients maintained a daily log documenting pain, nausea, use of pain medications, and return to daily activities. They also completed a QOL questionnaire (SF-36) before and after surgery. Design Classification: Prospective cohort study (Canadian Task Force Classification II-1). Setting: University teaching hospital. Patients: A total of 122 women undergoing laparoscopic hysterectomy. Measurements and Main Results: A total of 122 women underwent TLH (n 5 71) or LSH (n 5 51) for benign indications from February 2008 to January 2010. There was a significantly higher postoperative improvement of QOL scores in the LSH group in 6 of 10 questionnaire categories and summary scores, including physical functioning (p 5.03), role physical (p 5.002), and bodily pain (p 5.03). There were no significant differences in use of pain medications, level of pain, level of nausea, or return to normal activities. Conclusion: LSH appears to provide greater improvement in short-term postoperative QOL compared with TLH. No significant differences were found in postoperative pain or return to daily activities. Journal of Minimally Invasive Gynecology (2011) 18, 617–621 Ó 2011 AAGL. All rights reserved. Keywords:
DISCUSS
Laparoscopic; Hysterectomy; Supracervical
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-18-5-1703
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Hysterectomy is one of the most commonly performed surgical procedures in the United States, with 570 000 cases performed in 2006 [1]. The most common indications include uterine myoma, abnormal uterine bleeding, and pelvic organ prolapse [2]. Approximately, 45% of women in the United States above the age of 70 have undergone a hysterectomy in their lifetime [3].
The authors do not have any conflicts of interest or financial disclosures. Corresponding author: Jon I. Einarsson, MD, MPH, Brigham and Women’s Hospital, 75 Francis St, ASB 1-3, Boston, MA 02115. E-mail: [email protected] Submitted April 20, 2011. Accepted for publication June 2, 2011. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2011 AAGL. All rights reserved. doi:10.1016/j.jmig.2011.06.003
Vaginal hysterectomy and laparoscopic hysterectomy are commonly referred to as minimally invasive approaches because of consistent findings of significantly decreased morbidity rates when compared with abdominal hysterectomy, including less pain, shorter hospital stay, and a more rapid resumption of normal activities [4]. Despite these findings, abdominal hysterectomy continues to be the most common surgical approach in the United States [5]. A recent nationwide study found that 66.1% of hysterectomies were performed via a laparotomy, 21.8% were vaginal, and 11.8% were laparoscopic [5]. Preservation of the cervix at the time of hysterectomy has not been shown to confer significant benefit to patients during a standard abdominal hysterectomy [6]; nevertheless laparoscopic supracervical hysterectomy (LSH) is a common
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Journal of Minimally Invasive Gynecology, Vol 18, No 5, September/October 2011
practice, with proponents claiming a more rapid postoperative recovery than after a total laparoscopic hysterectomy (TLH). Observational data indicate that the mean time to resumption of normal activity after LSH and TLH is 2 weeks and 3 weeks, respectively [4,7]. However, there are currently no published prospective studies that compare return to daily activities and quality of life in the perioperative period after these commonly performed procedures. Therefore we were interested to prospectively compare postoperative recovery and perioperative quality of life after LSH and TLH. The primary outcome measure was return to normal activities, which was defined as the time when patients are able to function without restrictions in their daily lives. Secondary short-term endpoints included quality of life (QOL), postoperative pain, postoperative nausea, and use of narcotics and nonsteroidal antiinflammatory pain medications. Materials and Methods This was a prospective cohort study with enrollment taking place from February 2008 until January 2010. All women in our practice who were scheduled to undergo a laparoscopic hysterectomy for benign indications were offered to participate in this study. Exclusion criteria included malignancy of the uterus, cervix, or adnexa. The allocation to each study group was by patient preference, and patients were therefore not blinded toward the removal of the cervix. Patients were counseled before surgery that there were insufficient data comparing perioperative outcomes and quality of life after LSH and TLH and that it was unclear whether removal of the cervix influenced these parameters. Starting on the day of surgery, patients completed a 3-week daily diary documenting their use of narcotics and nonsteroidal antiinflammatory medications, as well as their pain and nausea level and the date of their return to normal activities (work, household chores, driving and exercise). In addition, patients completed a standardized SF-36 questionnaire immediately before surgery and again 3 to 4 weeks after surgery. The SF-36 questionnaire is a generic health survey that measures functional health and well-being from the patient’s point of view. It can be used across age, disease, and treatment groups and is commonly used to measure quality of life in a variety of situations, including after surgery [8–10]. The health survey measures 8 health domains: physical functioning, role physical, bodily pain, vitality, social functioning, role-emotional, general health, and mental health, and provides psychometrically-based physical component summary and Mental Component Summary scores. All surgeries were performed by 2 of the authors (J.I.E. and B.W.) with active resident and fellow participation. The basic surgical technique has been described in an earlier publication [11]. We defined operating time as the time from first skin incision until the closure of the last skin incision. Perioperative and postoperative parameters were collected prospectively. Informed consent was obtained before patient
recruitment, and the study was reviewed and approved by the Partners Institutional Review Board. On the basis of prior studies [4,7], return to normal activities occurs in 14 days after an LSH and in 21 days after a TLH. To have 80% power to detect this difference, and given a standard deviation of 12 days and an alpha of 0.05, we estimated that we would have to enroll 49 patients into each study group for a total of 98 study participants. Missing data were observed for several variables. Among these variables, body mass index (7% of data), smoking (7% of data), return to work (22% of data), and return to exercise (16% of data) were missing more than 5% of record [12]. The pattern of missing data seemed to be completely random. We excluded cases with missing variables for the analysis. For SF-36 data, missing responses were imputed by the half-scale rule, which states that the score should be calculated if the respondent answers at least 50% of the items in a multiitem scale. If anyone missed more than 50% of responses, they were excluded from the SF-36 data analysis. Two types of operation were compared by use of c2 tests or Fisher’s exact tests for categorical variables and Student’s t tests or Wilcoxon rank sum tests for numerical variables. Appropriate transformation was performed on some outcome variables to meet statistical assumptions. Because of the small sample size, series of multiple linear regression analyses were performed to adjust for potential confounders individually. We performed an adjusted analysis for the following confounders: age, body mass index, smoking, uterine weight, history of uterine fibroids, and history of endometriosis. We also performed a separate analysis excluding patients with endometriosis. The data for return to normal activities and norm-based mental component summary scores were left-skewed. To meet linear regression assumptions, a log transformation was performed on return to normal activities. A square root transformation was performed on norm-based mental component summary scores. All statistical analysis was performed with SAS v9.1 (SAS Institute, Cary, NC). All p values were 2-sided, and those less than .05 were considered to indicate statistical significance. Results Patient demographics and indications for surgery are shown in Table 1. More patients were enrolled in the TLH group than in the LSH group, because enrollment in the LSH group was slower, and we continued to enroll patients into the TLH group while we completed the planned enrollment into the LSH group. The groups had similar characteristics, except there were significantly more patients with endometriosis who underwent TLH than LSH. Table 2 compares perioperative outcomes between the groups. Although perioperative parameters were similar, there were more complications and readmissions in the TLH group; however, this did not reach statistical significance. Two patients in the TLH group presented to the hospital with vaginal cuff bleeding that required vaginal suturing in the operation room, and
Einarsson et al.
Prospective Evaluation of Quality of Life in Total versus Supracervical Laparoscopic Hysterectomy
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Table 1 Patient’s baseline characteristics
Age (y) Gravida Nulliparity Race White Hispanic Asian Black Other BMI (kg/m2) Menopausal Smoking Indication for hysterectomy Uterine fibroids Pelvic pain Endometriosis AUB
TLH (n 5 71)
LSH (n 5 51)
p Value
49.0 6 8.3 2 [1, 3] (n 5 69) 15/69 (21.7)
48.1 6 8.8 2 [0, 3] (n 5 50) 16/50 (32.0)
.5452 .1933 .2081 .1850
63/69 (91.1) 4/69 (5.8) 1/69 (1.5) 1/69 (1.5) 0/69 (0) 27.9 6 8.2 (n 5 67) 19/69 (27.5) 7/67 (10.4)
41/49 (92.6) 3/49 (6.1) 2/49 (4.1) 0/49 (0) 3/49 (6.1) 25.9 6 7.9 (n 5 46) 8/51 (15.7) 0/47 (0)
41 (57.7) 46 (64.8) 12 (16.9) 33 (46.5)
38 (74.5) 37 (72.5) 2 (3.9) 30 (58.8)
.1874 .1244 .0401 .0559 .3646 .0410 .1784
AUB 5 Abnormal uterine bleeding. Categorical variables are presented with frequency counts (%). Numerical variables are presented with mean 6 SD or median [Q1, Q3]. The p values were obtained by excluding missing data.
another patient presented with vaginal cuff cellulitis. One patient in the TLH group was diagnosed with a urinary tract infection that resolved with oral ciprofloxacin. One intraoperative complication occurred in the TLH group. This was a vaginal sulcus tear, likely caused by delivering an enlarged uterus through the vagina. This was easily repaired while closing the vaginal cuff laparoscopically. Table 3 compares postoperative pain and nausea, as well as return to daily activities. We did not find any significant difference between the groups in these categories. In general, patients used narcotic pain medications on average for 3 to 4 days after surgery and had minimal pain (less than 4/10) within 2 to 3 days after surgery. Table 4 compares changes in QOL scores between the groups. Interestingly we found sig-
nificantly better improvement in QOL among the LSH cohort in the following domains: physical functioning, role physical, bodily pain, vitality, social functioning and physical component summary. Multiple linear regression analysis looking at various potential confounders, including smoking and endometriosis, did not significantly alter the results of the data analysis. In addition, excluding patients with endometriosis from the analysis did not alter the findings of our study. Discussion In this prospective cohort study, we found that patients undergoing LSH seem to have a significantly better improvement in several validated quality of life parameters when
Table 2 Perioperative outcomes
Operating time (min) Uterine weight (g) Estimated blood loss (mL) Hospital stay Intraoperative complications Postoperative complications Blood transfusion Overall complications Readmission
TLH (n 5 71)
LSH (n 5 51)
p Value
131.9 6 42.4 (n 5 70) 197 [102, 372] 50 [30, 50] 1 [0.5, 1] (n 5 70) 1 (1.4) 4 (5.6) 1/70 (1.4) 5 (7.0) 2 (2.8)
134.7 6 46.6 (n 5 49) 276 [103, 500] (n 5 49) 50 [20, 100] (n 5 48) 0.5 [0.5, 1] 0 (0) 0 (0) 0/50 (0) 0 (0) 0 (0)
.7364 .2880 .6110 .0115 ..99 .1391 1.0 .0741 .5094
Categorical variables are presented with frequency counts (%). Numerical variables are presented with mean 6 SD or median [Q1, Q3]. The p values were obtained by excluding missing data.
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Journal of Minimally Invasive Gynecology, Vol 18, No 5, September/October 2011
Table 3 Postoperative pain and nausea and return to daily activities
Narcotics use NSAID use Pain level .4* Pain level .2* Nausea level .2* Return to household chores Return to driving Return to work Return to exercise Return to normal activities
TLH (n 5 71)
LSH (n 5 51)
p Value
4 [1. 6] 8 [4, 17] 3 [1, 6] 6 [3, 13] 0 [0, 2] (n 5 70) 9 [4, 10] (n 5 68) 7 [5, 11] (n 5 69) 17 [7.5, 30] (n 5 60) 12 [6, 21.5] (n 5 60) 20 [12, 30]
3 [0, 7] (n 5 49) 7 [5, 12] (n 5 49) 2 [0. 4] (n 5 49) 5 [2, 11] (n 5 49) 0 [0, 1] (n 5 49) 4 [2, 11] (n 5 48) 6 [4, 11] (n 5 47) 11 [6, 30] (n 5 35) 12 [5, 20] (n 5 43) 15 [12, 25] (n 5 49)
.1859 .3922 .1171 .3476 .5339 .0630 .4149 .2579 .8595 .4118
NSAID 5 Nonsteroidal antiinflammatory drugs. Data are presented as median days [Q1, Q3]. The p values were obtained by excluding missing data. * Level of nausea and pain on a 1-10 visual analogue scale.
compared with patients undergoing TLH. We did not, however, find any significant differences in postoperative pain, nausea, use of narcotic pain medications, or return to daily activities between the groups. To our knowledge this is the first study to prospectively compare perioperative quality of life in patients undergoing laparoscopic hysterectomy. We are uncertain why we detected a significantly better improvement in several QOL parameters in the LSH group, whereas we did not find significant differences in traditional postoperative parameters such as pain, use of pain medication, and return to daily activities. This difference in quality of life may be multifactorial. We had 2 readmissions in the TLH group and none in the LSH group. Although this was not statistically significant, it is conceivable that this may have decreased the overall QOL improvement in the TLH group. In addition, although statistically significant differences
were not detected in individual postoperative parameters, patients in the LSH group appeared to return to daily activities 5 days earlier than the patients in the TLH group. It is possible that we are not detecting a significant difference in these parameters because of type II error and that the validated QOL questionnaire is sensitive enough to detect the difference between the groups. An obvious shortcoming of our study is that the patients were not randomized, and therefore the results are subject to a number of biases. In addition, patients were not blinded to whether the cervix was removed, and this may have affected their bodily perception. During our preoperative counseling of patients, we did not claim that their quality of life or recovery would be better with one modality versus the other; however, some patients may have come with preconceived ideas or expectations that may have affected the findings of our study. Ultimately, the patients made the final decision
Table 4 Change (before to after surgery) in quality of life scores (norm-based scores) TLH (n 5 70)* Physical functioning Role physical Bodily pain General health Vitality Social functioning Role emotionaly Mental health Physical component summaryy Mental component summaryy
LSH (n 5 49)*
Mean 6SD
Median [Q1, Q3]
Mean 6SD
Median [Q1, Q3]
p Value
22.2 6 9.7 27.8 6 11.1 21.8 6 10.9 1.9 6 5.8 0.5 6 12.2 23.4 6 9.8 1.3 6 10.8 4.3 6 9.6 25.0 6 8.5 6.5 6 8.6
21.1 [24.2, 2.1] 27.3 [214.7, 0.0] 22.5 [28.9, 8.0] 0.0 [21.4, 4.8] 0.0 [29.4, 9.4] 0.0 [210.9, 0.0] 0.0 [0.0, 3.9] 2.8 [0.0, 8.4] 24.2 [210.5, 0.3] 6.8 [1.2, 11.5]
0.5 6 10.3 20.9 6 13.8 2.6 6 9.6 2.6 6 6.3 6.2 6 12.5 4.7 6 11.2 4.4 6 11.6 7.4 6 9.1 21.0 6 9.9 8.4 6 10.4
0.0 [0.0, 6.3] 0.0 [29.8, 9.8] 1.3 [24.2, 9.3] 2.4 [0.0, 4.8] 6.2 [0.0, 9.4] 0.0 [0.0, 10.9] 0.0 [0.0, 11.7] 5.6 [0.0, 11.3] 20.3 [27.9, 5.1] 4.9 [0.8, 15.3]
.0294 .0021 .0267 .3953 .0141 .0001 .0563 .0742 .0176 .7486
The p values were obtained from Wilcoxon rank-sum tests. * Three subjects did not complete more than 50% of questions; therefore they were excluded from this table. y One subject did not complete all questions for Role Emotional; therefore he/she was excluded from calculation from the role emotional, physical component summary and mental component summary calculation.
Einarsson et al.
Prospective Evaluation of Quality of Life in Total versus Supracervical Laparoscopic Hysterectomy
regarding whether the cervix was removed at the time of hysterectomy. In our experience, retention of the cervix is not important to most women; however, a number of women feel very strongly about retaining their cervix, and this may affect their postoperative perception of items in the SF-36 such as physical role and physical component summary. In conclusion, we found that women undergoing LSH had a significantly better improvement in short-term postoperative quality of life compared with women undergoing TLH. However, we did not find significant differences in return to daily activities, perioperative pain, or use of pain medication. References 1. DeFrances CJ, Lucas CA, Buie VC, Golosinskiy A. 2006 National Hospital Discharge Survey. Natl Health Stat Report. 2008;5:1–20. 2. Merrill RM. Hysterectomy surveillance in the United States, 1997 through 2005. Med Sci Monit. 2008;14:24–31. 3. Merrill RM, Layman AB, Oderda G, Asche C. Risk estimates of hysterectomy and selected conditions commonly treated with hysterectomy. Ann Epidemiol. 2008;18:253–260.
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4. Johnson N, Barlow D, Lethaby A, Tavender E, Curr E, Garry R. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2006;2:CD003677. 5. Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110: 1091–1095. 6. Lethaby A, Ivanova V, Johnson NP. Total versus subtotal hysterectomy for benign gynaecological conditions. Cochrane Database Syst Rev. 2006;(2):CD004993. 7. Jenkins TR. Laparoscopic supracervical hysterectomy. Am J Obstet Gynecol. 2004;191:1875–1884. 8. Hobson P, Bhowmick B, Meara J. Use of the SF-36 questionnaire in cerebrovascular disease. Stroke. 1997;28:464–465. 9. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992; 30:473–483. 10. McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994;32:40–66. 11. Einarsson JI, Suzuki Y. Total laparoscopic hysterectomy: 10 steps toward a successful procedure. Rev Obstet Gynecol. 2009;2:57–64. 12. Ware JE, Kosinski M, Bjorner JB, Turner-Bowker DM, Gandek B, Maruish ME. User’s manual for the SF-36v2 Health Survey. 2nd ed. Lincoln, RI: QualityMetric Incorporated; 2007.
Prospective Evaluation of Quality of Life in Total versus Supracervical Laparoscopic Hysterectomy Jon I. Einarsson, MD, MPH*, Yoko Suzuki, MD, MPH, Thomas T. Vellinga, Gudrun M. Jonsdottir, Magnus K. Magnusson, MD, Rie Maurer, Honami Yoshida, MD, PhD, MPH, and Brian Walsh, MD From Brigham and Women’s Hospital, Boston, Massachusetts (all authors) .
ABSTRACT Study Objective: To evaluate and compare recovery times and quality of life (QOL) in patients undergoing a total laparoscopic hysterectomy (TLH) and laparoscopic supracervical hysterectomy (LSH). Design: Patients underwent either a TLH or LSH. After surgery, patients maintained a daily log documenting pain, nausea, use of pain medications, and return to daily activities. They also completed a QOL questionnaire (SF-36) before and after surgery. Design Classification: Prospective cohort study (Canadian Task Force Classification II-1). Setting: University teaching hospital. Patients: A total of 122 women undergoing laparoscopic hysterectomy. Measurements and Main Results: A total of 122 women underwent TLH (n 5 71) or LSH (n 5 51) for benign indications from February 2008 to January 2010. There was a significantly higher postoperative improvement of QOL scores in the LSH group in 6 of 10 questionnaire categories and summary scores, including physical functioning (p 5.03), role physical (p 5.002), and bodily pain (p 5.03). There were no significant differences in use of pain medications, level of pain, level of nausea, or return to normal activities. Conclusion: LSH appears to provide greater improvement in short-term postoperative QOL compared with TLH. No significant differences were found in postoperative pain or return to daily activities. Journal of Minimally Invasive Gynecology (2011) 18, 617–621 Ó 2011 AAGL. All rights reserved. Keywords:
DISCUSS
Laparoscopic; Hysterectomy; Supracervical
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-18-5-1703
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Hysterectomy is one of the most commonly performed surgical procedures in the United States, with 570 000 cases performed in 2006 [1]. The most common indications include uterine myoma, abnormal uterine bleeding, and pelvic organ prolapse [2]. Approximately, 45% of women in the United States above the age of 70 have undergone a hysterectomy in their lifetime [3].
The authors do not have any conflicts of interest or financial disclosures. Corresponding author: Jon I. Einarsson, MD, MPH, Brigham and Women’s Hospital, 75 Francis St, ASB 1-3, Boston, MA 02115. E-mail: [email protected] Submitted April 20, 2011. Accepted for publication June 2, 2011. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2011 AAGL. All rights reserved. doi:10.1016/j.jmig.2011.06.003
Vaginal hysterectomy and laparoscopic hysterectomy are commonly referred to as minimally invasive approaches because of consistent findings of significantly decreased morbidity rates when compared with abdominal hysterectomy, including less pain, shorter hospital stay, and a more rapid resumption of normal activities [4]. Despite these findings, abdominal hysterectomy continues to be the most common surgical approach in the United States [5]. A recent nationwide study found that 66.1% of hysterectomies were performed via a laparotomy, 21.8% were vaginal, and 11.8% were laparoscopic [5]. Preservation of the cervix at the time of hysterectomy has not been shown to confer significant benefit to patients during a standard abdominal hysterectomy [6]; nevertheless laparoscopic supracervical hysterectomy (LSH) is a common
618
Journal of Minimally Invasive Gynecology, Vol 18, No 5, September/October 2011
practice, with proponents claiming a more rapid postoperative recovery than after a total laparoscopic hysterectomy (TLH). Observational data indicate that the mean time to resumption of normal activity after LSH and TLH is 2 weeks and 3 weeks, respectively [4,7]. However, there are currently no published prospective studies that compare return to daily activities and quality of life in the perioperative period after these commonly performed procedures. Therefore we were interested to prospectively compare postoperative recovery and perioperative quality of life after LSH and TLH. The primary outcome measure was return to normal activities, which was defined as the time when patients are able to function without restrictions in their daily lives. Secondary short-term endpoints included quality of life (QOL), postoperative pain, postoperative nausea, and use of narcotics and nonsteroidal antiinflammatory pain medications. Materials and Methods This was a prospective cohort study with enrollment taking place from February 2008 until January 2010. All women in our practice who were scheduled to undergo a laparoscopic hysterectomy for benign indications were offered to participate in this study. Exclusion criteria included malignancy of the uterus, cervix, or adnexa. The allocation to each study group was by patient preference, and patients were therefore not blinded toward the removal of the cervix. Patients were counseled before surgery that there were insufficient data comparing perioperative outcomes and quality of life after LSH and TLH and that it was unclear whether removal of the cervix influenced these parameters. Starting on the day of surgery, patients completed a 3-week daily diary documenting their use of narcotics and nonsteroidal antiinflammatory medications, as well as their pain and nausea level and the date of their return to normal activities (work, household chores, driving and exercise). In addition, patients completed a standardized SF-36 questionnaire immediately before surgery and again 3 to 4 weeks after surgery. The SF-36 questionnaire is a generic health survey that measures functional health and well-being from the patient’s point of view. It can be used across age, disease, and treatment groups and is commonly used to measure quality of life in a variety of situations, including after surgery [8–10]. The health survey measures 8 health domains: physical functioning, role physical, bodily pain, vitality, social functioning, role-emotional, general health, and mental health, and provides psychometrically-based physical component summary and Mental Component Summary scores. All surgeries were performed by 2 of the authors (J.I.E. and B.W.) with active resident and fellow participation. The basic surgical technique has been described in an earlier publication [11]. We defined operating time as the time from first skin incision until the closure of the last skin incision. Perioperative and postoperative parameters were collected prospectively. Informed consent was obtained before patient
recruitment, and the study was reviewed and approved by the Partners Institutional Review Board. On the basis of prior studies [4,7], return to normal activities occurs in 14 days after an LSH and in 21 days after a TLH. To have 80% power to detect this difference, and given a standard deviation of 12 days and an alpha of 0.05, we estimated that we would have to enroll 49 patients into each study group for a total of 98 study participants. Missing data were observed for several variables. Among these variables, body mass index (7% of data), smoking (7% of data), return to work (22% of data), and return to exercise (16% of data) were missing more than 5% of record [12]. The pattern of missing data seemed to be completely random. We excluded cases with missing variables for the analysis. For SF-36 data, missing responses were imputed by the half-scale rule, which states that the score should be calculated if the respondent answers at least 50% of the items in a multiitem scale. If anyone missed more than 50% of responses, they were excluded from the SF-36 data analysis. Two types of operation were compared by use of c2 tests or Fisher’s exact tests for categorical variables and Student’s t tests or Wilcoxon rank sum tests for numerical variables. Appropriate transformation was performed on some outcome variables to meet statistical assumptions. Because of the small sample size, series of multiple linear regression analyses were performed to adjust for potential confounders individually. We performed an adjusted analysis for the following confounders: age, body mass index, smoking, uterine weight, history of uterine fibroids, and history of endometriosis. We also performed a separate analysis excluding patients with endometriosis. The data for return to normal activities and norm-based mental component summary scores were left-skewed. To meet linear regression assumptions, a log transformation was performed on return to normal activities. A square root transformation was performed on norm-based mental component summary scores. All statistical analysis was performed with SAS v9.1 (SAS Institute, Cary, NC). All p values were 2-sided, and those less than .05 were considered to indicate statistical significance. Results Patient demographics and indications for surgery are shown in Table 1. More patients were enrolled in the TLH group than in the LSH group, because enrollment in the LSH group was slower, and we continued to enroll patients into the TLH group while we completed the planned enrollment into the LSH group. The groups had similar characteristics, except there were significantly more patients with endometriosis who underwent TLH than LSH. Table 2 compares perioperative outcomes between the groups. Although perioperative parameters were similar, there were more complications and readmissions in the TLH group; however, this did not reach statistical significance. Two patients in the TLH group presented to the hospital with vaginal cuff bleeding that required vaginal suturing in the operation room, and
Einarsson et al.
Prospective Evaluation of Quality of Life in Total versus Supracervical Laparoscopic Hysterectomy
619
Table 1 Patient’s baseline characteristics
Age (y) Gravida Nulliparity Race White Hispanic Asian Black Other BMI (kg/m2) Menopausal Smoking Indication for hysterectomy Uterine fibroids Pelvic pain Endometriosis AUB
TLH (n 5 71)
LSH (n 5 51)
p Value
49.0 6 8.3 2 [1, 3] (n 5 69) 15/69 (21.7)
48.1 6 8.8 2 [0, 3] (n 5 50) 16/50 (32.0)
.5452 .1933 .2081 .1850
63/69 (91.1) 4/69 (5.8) 1/69 (1.5) 1/69 (1.5) 0/69 (0) 27.9 6 8.2 (n 5 67) 19/69 (27.5) 7/67 (10.4)
41/49 (92.6) 3/49 (6.1) 2/49 (4.1) 0/49 (0) 3/49 (6.1) 25.9 6 7.9 (n 5 46) 8/51 (15.7) 0/47 (0)
41 (57.7) 46 (64.8) 12 (16.9) 33 (46.5)
38 (74.5) 37 (72.5) 2 (3.9) 30 (58.8)
.1874 .1244 .0401 .0559 .3646 .0410 .1784
AUB 5 Abnormal uterine bleeding. Categorical variables are presented with frequency counts (%). Numerical variables are presented with mean 6 SD or median [Q1, Q3]. The p values were obtained by excluding missing data.
another patient presented with vaginal cuff cellulitis. One patient in the TLH group was diagnosed with a urinary tract infection that resolved with oral ciprofloxacin. One intraoperative complication occurred in the TLH group. This was a vaginal sulcus tear, likely caused by delivering an enlarged uterus through the vagina. This was easily repaired while closing the vaginal cuff laparoscopically. Table 3 compares postoperative pain and nausea, as well as return to daily activities. We did not find any significant difference between the groups in these categories. In general, patients used narcotic pain medications on average for 3 to 4 days after surgery and had minimal pain (less than 4/10) within 2 to 3 days after surgery. Table 4 compares changes in QOL scores between the groups. Interestingly we found sig-
nificantly better improvement in QOL among the LSH cohort in the following domains: physical functioning, role physical, bodily pain, vitality, social functioning and physical component summary. Multiple linear regression analysis looking at various potential confounders, including smoking and endometriosis, did not significantly alter the results of the data analysis. In addition, excluding patients with endometriosis from the analysis did not alter the findings of our study. Discussion In this prospective cohort study, we found that patients undergoing LSH seem to have a significantly better improvement in several validated quality of life parameters when
Table 2 Perioperative outcomes
Operating time (min) Uterine weight (g) Estimated blood loss (mL) Hospital stay Intraoperative complications Postoperative complications Blood transfusion Overall complications Readmission
TLH (n 5 71)
LSH (n 5 51)
p Value
131.9 6 42.4 (n 5 70) 197 [102, 372] 50 [30, 50] 1 [0.5, 1] (n 5 70) 1 (1.4) 4 (5.6) 1/70 (1.4) 5 (7.0) 2 (2.8)
134.7 6 46.6 (n 5 49) 276 [103, 500] (n 5 49) 50 [20, 100] (n 5 48) 0.5 [0.5, 1] 0 (0) 0 (0) 0/50 (0) 0 (0) 0 (0)
.7364 .2880 .6110 .0115 ..99 .1391 1.0 .0741 .5094
Categorical variables are presented with frequency counts (%). Numerical variables are presented with mean 6 SD or median [Q1, Q3]. The p values were obtained by excluding missing data.
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Journal of Minimally Invasive Gynecology, Vol 18, No 5, September/October 2011
Table 3 Postoperative pain and nausea and return to daily activities
Narcotics use NSAID use Pain level .4* Pain level .2* Nausea level .2* Return to household chores Return to driving Return to work Return to exercise Return to normal activities
TLH (n 5 71)
LSH (n 5 51)
p Value
4 [1. 6] 8 [4, 17] 3 [1, 6] 6 [3, 13] 0 [0, 2] (n 5 70) 9 [4, 10] (n 5 68) 7 [5, 11] (n 5 69) 17 [7.5, 30] (n 5 60) 12 [6, 21.5] (n 5 60) 20 [12, 30]
3 [0, 7] (n 5 49) 7 [5, 12] (n 5 49) 2 [0. 4] (n 5 49) 5 [2, 11] (n 5 49) 0 [0, 1] (n 5 49) 4 [2, 11] (n 5 48) 6 [4, 11] (n 5 47) 11 [6, 30] (n 5 35) 12 [5, 20] (n 5 43) 15 [12, 25] (n 5 49)
.1859 .3922 .1171 .3476 .5339 .0630 .4149 .2579 .8595 .4118
NSAID 5 Nonsteroidal antiinflammatory drugs. Data are presented as median days [Q1, Q3]. The p values were obtained by excluding missing data. * Level of nausea and pain on a 1-10 visual analogue scale.
compared with patients undergoing TLH. We did not, however, find any significant differences in postoperative pain, nausea, use of narcotic pain medications, or return to daily activities between the groups. To our knowledge this is the first study to prospectively compare perioperative quality of life in patients undergoing laparoscopic hysterectomy. We are uncertain why we detected a significantly better improvement in several QOL parameters in the LSH group, whereas we did not find significant differences in traditional postoperative parameters such as pain, use of pain medication, and return to daily activities. This difference in quality of life may be multifactorial. We had 2 readmissions in the TLH group and none in the LSH group. Although this was not statistically significant, it is conceivable that this may have decreased the overall QOL improvement in the TLH group. In addition, although statistically significant differences
were not detected in individual postoperative parameters, patients in the LSH group appeared to return to daily activities 5 days earlier than the patients in the TLH group. It is possible that we are not detecting a significant difference in these parameters because of type II error and that the validated QOL questionnaire is sensitive enough to detect the difference between the groups. An obvious shortcoming of our study is that the patients were not randomized, and therefore the results are subject to a number of biases. In addition, patients were not blinded to whether the cervix was removed, and this may have affected their bodily perception. During our preoperative counseling of patients, we did not claim that their quality of life or recovery would be better with one modality versus the other; however, some patients may have come with preconceived ideas or expectations that may have affected the findings of our study. Ultimately, the patients made the final decision
Table 4 Change (before to after surgery) in quality of life scores (norm-based scores) TLH (n 5 70)* Physical functioning Role physical Bodily pain General health Vitality Social functioning Role emotionaly Mental health Physical component summaryy Mental component summaryy
LSH (n 5 49)*
Mean 6SD
Median [Q1, Q3]
Mean 6SD
Median [Q1, Q3]
p Value
22.2 6 9.7 27.8 6 11.1 21.8 6 10.9 1.9 6 5.8 0.5 6 12.2 23.4 6 9.8 1.3 6 10.8 4.3 6 9.6 25.0 6 8.5 6.5 6 8.6
21.1 [24.2, 2.1] 27.3 [214.7, 0.0] 22.5 [28.9, 8.0] 0.0 [21.4, 4.8] 0.0 [29.4, 9.4] 0.0 [210.9, 0.0] 0.0 [0.0, 3.9] 2.8 [0.0, 8.4] 24.2 [210.5, 0.3] 6.8 [1.2, 11.5]
0.5 6 10.3 20.9 6 13.8 2.6 6 9.6 2.6 6 6.3 6.2 6 12.5 4.7 6 11.2 4.4 6 11.6 7.4 6 9.1 21.0 6 9.9 8.4 6 10.4
0.0 [0.0, 6.3] 0.0 [29.8, 9.8] 1.3 [24.2, 9.3] 2.4 [0.0, 4.8] 6.2 [0.0, 9.4] 0.0 [0.0, 10.9] 0.0 [0.0, 11.7] 5.6 [0.0, 11.3] 20.3 [27.9, 5.1] 4.9 [0.8, 15.3]
.0294 .0021 .0267 .3953 .0141 .0001 .0563 .0742 .0176 .7486
The p values were obtained from Wilcoxon rank-sum tests. * Three subjects did not complete more than 50% of questions; therefore they were excluded from this table. y One subject did not complete all questions for Role Emotional; therefore he/she was excluded from calculation from the role emotional, physical component summary and mental component summary calculation.
Einarsson et al.
Prospective Evaluation of Quality of Life in Total versus Supracervical Laparoscopic Hysterectomy
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