How to Quantify Recovery After Laparoscopic Adrenalectomy: An Assessment of Patient-reported Health-related Quality of Life
Ostap Dovirak, MD,* Jialin Mao, MPH,t Kimberly Taylor, BS, MA,* Peter Chang, MD, MPH,* and Andrew A. Wagner, MD*
Introduction and Objective: Minimally invasive approaches to adrenal surgery were adopted in an attempt to reduce surgical morbidity. Despite the widespread use, few studies objectively evaluate health-related quality of life (HRQOL) in patients undergoing laparoscopic adrenalectomy (LA). We assessed patients’ health status and recovery after LA with the use of vali- dated questionnaires.
Methods: Patients seen in urology clinic for evaluation of adrenal surgery were enlisted in our prospective, patient-reported, HRQOL study assessing postoperative recovery. HRQOL was measured using Convalescence And Recovery Evaluation (CARE) and Short Form-12 questionnaires administered before surgery and at 2, 4, 8, 12 weeks and annually after surgery. All operations were per- formed using a laparoscopic transperitoneal approach by a single fellowship-trained surgeon.
Results: A total of 30 patients who met study inclusion criteria from July 2009 to November 2014 were included in our evaluation. Mean patient age was 53 years. Tumor size ranged from 2.0 to 5.5 cm and consisted of benign lesions, adrenal metastasis, and 1 adrenocortical carcinoma. Mean operative time was 98 minutes and median estimated blood loss was 50 mL. Median length of hospital stay was 1 day. Quality of life reflected by the CARE survey was impacted at 2 weeks postoperative and returned to baseline after 4 weeks. Pain and activity domains of CARE showed a significant decrease from baseline status. Physical component summary of Short Form-12 questionnaire supported the finding of negative impact of surgery on activity level within first 4 weeks of recovery.
Conclusions: Despite minimally invasive approach, patients undergoing LA may require about 4 weeks to return to baseline activity, gastrointestinal, and pain status.
Key Words: laparoscopic adrenalectomy, health-related quality of life, postoperative recovery, CARE, SF-12
(Surg Laparosc Endosc Percutan Tech 2016;26:290-294)
L aparoscopic adrenalectomy (LA) has become common- place for surgical management of most adrenal tumors due to improvements in convalescence over open surgery.
From the *Department of Surgery, Division of Urology, Beth Israel Deaconess Medical Center, Boston, MA; and Department of Healthcare Policy and Research, Weil Cornell Medical College, New York, NY.
The authors declare no conflicts of interest.
Reprints: Andrew A. Wagner, MD, Department of Surgery, Division of Urology, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Rabb 440, Boston, MA 02215 (e-mail: awagner@bidmc. harvard.edu).
Perioperative advantages of LA include quicker recovery, shorter hospitalization, less postoperative pain, and less blood loss.1-3 In addition, studies have demonstrated a reduction in wound, cardiac, pulmonary, and infectious complications,4,5 and improvements in operative time.6
Health-related quality of life (HRQOL) assessment measures physical, functional, mental, and social health resulting from disease and its treatment.7 Return to base- line preoperative functional status, as measured by patient- reported HRQOL, can be used to better understand the phenomenon of recovery and how it may vary between surgical approaches.8 In addition, this information can also be used to help surgeons counsel patients and their families, and set realistic expectations for con- valescence, potentially leading to improved overall patient satisfaction.
However, descriptions of recovery from LA using patient-reported outcomes are lacking. It is therefore unclear how much time is required for patients to return to baseline quality of life after LA, especially in the critical period between discharge and the first postoperative visit. We sought to perform the first prospective evaluation of patient-reported HRQOL after LA by using 2 validated questionnaires, the Short Form-12 (SF-12), a general HRQOL instrument, and Convalescence and Recovery Evaluation (CARE), a validated HRQOL instrument designed to measure convalescence after abdominal and pelvic surgery.8,9
MATERIALS AND METHODS
Subject Population
We offered all English-speaking patients undergoing LA at our institution from July 2009 to November 2014 an opportunity to enroll in a prospective, patient-reported, HRQOL study assessing postoperative recovery. During this time period, 65 LA were performed and a total of 30 patients met the criteria for the study, agreed to participate, and filled out a baseline questionnaire and at least 1 post- operative survey. Study design was compliant with Health Insurance Probability and Accountability Act (HIPAA) and approved by our Institutional Review Board. All sub- jects underwent transperitoneal LA by a single urologist with minimally invasive fellowship training, using 5 lapa- roscopic ports on the right and 4 ports for left-sided cases. After surgery, subjects were placed on a 1- to 2-day inpa- tient adrenalectomy nursing pathway. They were also asked to avoid driving for 2 weeks and heavy lifting or exercise for 3 weeks after discharge.
Measures
We used 2 validated HRQOL instruments to assess recovery. The SF-12 has been widely accepted as a useful tool in monitoring health status of large patient pop- ulations. We chose the SF-12 for this study because of its relative simplicity and minimal time burden to the partic- ipant.10 The physical component score of SF-12 assessed subjects’ limitations in physical function. The mental component score was evaluated through 4 questions that predict mental health.9
The CARE is a 27-item instrument that was developed for measuring postoperative convalescence in patients after abdominal and pelvic surgeries.8 It provides a global overview of short-term patient outcomes and has been validated in a diverse patient population after laparoscopy and open surgery. CARE assesses convalescence in 4 domains including pain, activity, gastrointestinal (GI), and cognition.
Data Collection
We administered HRQOL questionnaires pre- operatively (baseline) and at 2, 4, 8, 12, and 52 weeks after surgery. Subjects completed questionnaires on paper or through a Web-based survey, based on their preference. We maintained and updated all data in our secure database provided by Research Electronic Data Capture Web application (REDCap).11 Participants were mailed paper questionnaires 1 week before due date and emails were sent out 2 days in advance. Subjects delinquent in responses were sent an incompletion reminder through e-mail or US Postal Service 2 days after time point due date. One final reminder in an attempt to collect data was delivered in a form of a phone call. No more than 3 attempts total were made in an effort to collect information for each given time point. Data collection window for the 2- and 4-week time points ended 1 week after due date. The window extended to 2 weeks after due date for 8 and 12 weeks’ time points and 12 weeks for 52-week time point. If a subject missed the window for collection of information, we attempted to recapture him or her at the next time point.
Statistical Methods
Subject characteristics were examined at baseline. Events and percentages were presented for categorical variables. Means and SDs or medians and interquartile ranges were presented for continuous variables. Subjects’ CARE and SF-12 scores were inspected at each time point of the questionnaire, including baseline, 2, 4, 8, and 12 weeks, and 1 year after surgery. Mixed repeated measures model was used to assess time effect on QOL scores within each surgery group. Changes in scores were then evaluated graphically.
RESULTS
During the study period, 30 subjects who underwent LA agreed to participate in the study and filled out their baseline surveys and at least 1 postoperative survey. Mean length of follow-up for the cohort was 16.7 months. Subject demographics and characteristics are described in Table 1. Average age of patients at the time of enrollment was 53 years and the cohort consisted of 10 (33.3%) males and 20 (67.7%) females. Most participants were in a good state of health preoperatively with a median Charlson comorbidity index of 2.5. A single fellowship-trained laparoscopic sur- geon performed surgeries with resident or fellow assistance.
| TABLE 1. Subject Demographics and Characteristics (N= 30) | |
|---|---|
| Mean (SD) | |
| Age at entry (y)} | 52.6 (14.4) |
| Male [n (%)] | 10 (33.3) |
| BMIĮ | 30.6 (7.3) |
| Charlson comorbidity score [median (IQR)]* | 2.5 (0.0-5.0) |
| Tumor size [median (IQR)] (cm)* | 3.4 (2.0-5.5) |
| Tumor pathologyt | |
| Adenomas | |
| Nonfunctional | 8 |
| Cushing syndrome | 3 |
| Conn syndrome | 6 |
| Pheochromocytoma | 7 |
| Hyperplasia | 1 |
| Ganglioneuroma | 1 |
| Myelolipoma | 1 |
| Metastastasis | 2 |
| Adrenocortical carcinoma | 1 |
| Operative time (min) | 97.7 (60.4) |
| Estimated blood loss [median (IQR)] (mL)* | 50.0 (20.0-50.0) |
| Length of hospital stay [median (IQR)] (d)* | 1.0 (1.0-2.0) |
| Transfusion | 0 |
| Clavien complication score [n (%)] | |
| None | 27 (90.0) |
| 1-2 | 2 (6.7) |
| 3-5 | 1 (3.3) |
*Baseline patient characteristics presented as a median score with IQR specified. ¡Tumor pathology assessed from surgical specimen. Adenoma func- tionality is based on clinical history. #Age, BMI, and operative time are presented as a mean with SD. BMI indicates body mass index; IQR, interquartile range.
Mean operative time was 98 minutes. Median estimated blood loss was 50mL; no subjects required an intra- operative or postoperative transfusion. Median hospital stay was 1 day. Ninety percent of subjects had no compli- cations during recovery and only 1 patient had a Clavien grade 3 complication requiring intubation and ICU stay for airway edema after removal of a 7 cm pheochromocytoma. Tumor characteristics are described in Table 1.
All analyzed subjects reported their HRQOL at base- line and at least 1 additional time point over a 1-year fol- low-up period. We present a full breakdown of response completion in Table 2.
HRQOL changes over time as assessed by the CARE and SF-12 instruments are shown in Figure 1. On average, subjects experienced a significant decrease in overall CARE composite score 2 weeks after surgery. At 4 weeks, HRQOL changes from baseline were no longer statistically sig- nificant. These findings were mirrored in the pain and
| TABLE 2. Responses at Each Time Point for SF-12 and CARE | |
|---|---|
| Time | Response (N) |
| Baseline | 30 |
| 2 wk | 24 |
| 4 wk | 25 |
| 8 wk | 22 |
| 12 wk | 21 |
| 1 y | 13 |
(N) Questionnaire response rate at baseline and following laparoscopic adrenalectomy.
CARE
100
80
60
40
20
Baseline 2 weeks 4 weeks 8 weeks 12 weeks 1 year
Pain
Gastrointestinal
100
100
80
80
60
60
40
40
20
20
Baseline 2 weeks 4 weeks 8 weeks 12 weeks 1 year
Baseline 2 weeks 4 weeks 8 weeks 12 weeks 1 year
Cognition
Activity
100
100
80
80
60
60
40
40
20
20
Baseline 2 weeks 4 weeks 8 weeks 12 weeks 1 year
Baseline 2 weeks 4 weeks 8 weeks 12 weeks 1 year
PCS
MCS
100
100
80
80
60
60
40
40
20
20
Baseline 2 weeks 4 weeks 8 weeks 12 weeks 1 year
Baseline 2 weeks 4 weeks 8 weeks 12 weeks 1 year
activity domains of CARE, as well as the physical com- ponent summary of SF-12. No statistically significant changes in GI or cognition domains were noted in the first 4 weeks of recovery; however, there was small but significant improvement in these domains at 8 weeks. Overall improvement in CARE measure was also seen in all recorded time points after 4 weeks postoperatively. Change
in CARE and SF-12 components compared with baseline is shown in Table 3.
DISCUSSION
LA has become the standard surgical approach for removal of uncomplicated adrenal masses. Previous work
| TABLE 3. Mean Change of Score and Percentage of Change | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 2 wk | 4 wk | 8 wk | 12 wk | 1 y | ||||||
| Raw | % | Raw | % | Raw | % | Raw | % | Raw | % | |
| CARE | - 12.44 | -15.2 | 1.35 | 1.6 | 7.50 | 9.1 | 8.24 | 10.0 | 7.16 | 8.7 |
| Pain | - 14.94 | - 16.8 | -2.12 | -2.4 | 5.58 | 6.3 | 6.64 | 7.5 | 3.03 | 3.4 |
| GI | -3.86 | -4.5 | 3.30 | 3.8 | 7.24 | 8.4 | 5.37 | 6.2 | 10.53 | 12.2 |
| Cognition | 3.24 | 4.2 | 4.28 | 5.6 | 11.13 | 14.4 | 11.13 | 14.4 | 14.93 | 19.4 |
| Activity | -34.19 | -45.3 | -0.05 | -0.1 | 6.06 | 8.0 | 9.81 | 13.0 | 0.15 | 0.2 |
| SF-12 PCS | -14.32 | -30.3 | -6.77 | - 14.3 | 0.75 | 1.6 | 3.33 | 7.1 | -0.82 | -1.7 |
| SF-12 MCS | 3.47 | 7.0 | 2.81 | 5.7 | 5.08 | 10.3 | 4.36 | 8.8 | 6.98 | 14.1 |
Change in score in HRQOL questionnaires at each time point compared with baseline. All responses and change from baseline were converted to 100-point scale.
CARE indicates Convalescence And Recovery Evaluation; GI, gastrointestinal; HRQOL, health-related quality of life; MCS, mental component score; PCS, physical component score; SF-12, Short Form-12.
has demonstrated some disease-specific symptom im- provement after the removal of functional adrenal masses.12-14 However, to our knowledge, this study con- stitutes the first prospective description of postoperative convalescence using patient-reported HRQOL after LA.
Previously we, as well as others, have reported HRQOL outcomes after kidney surgery using CARE® and SF-12 surveys.10 The CARE instrument was specifically designed to evaluate patients recovering from abdominal or pelvic surgery. We demonstrated temporal changes in convalescence after renal surgery, and responsiveness of both surveys to meaningful differences in postoperative recovery across variety of domains. 10
Other groups have evaluated patients using validated instruments following short-stay general surgery procedures. Feldman et al15 evaluated patients after laparoscopic chol- ecystectomy using the SF-36 and the Community Health Activities Model Program for Seniors (CHAMPS), a 41-item instrument designed to evaluate physical activity in older patients, and found that over 50% of patients did not return to baseline HRQOL by 1 month. The same group evaluated 132 ambulatory surgery patients after a variety of surgeries including inguinal herniorrhaphy and laparoscopic chol- ecystectomy.16 Mirroring their earlier findings, 33% of patients did not return to baseline HRQOL by 2 months. Age and preoperative function were important factors in deter- mining return to baseline HRQOL. These studies suggest that recovery may be slower than expected after minimally inva- sive surgery. Our study echoed these findings, showing the recovery after LA to be about 1 month.
These results and ours suggest a potential gap between patient expectations and actual experiences, which may influence patient satisfaction. Indeed, objective data regarding postoperative recovery are of benefit to surgeons, patients, and families during preoperative counseling and potentially allow for improved overall patient sat- isfaction and avoidance of disappointment due to delayed recovery.17 This can begin with appropriate preoperative counseling about actual recovery milestones after hospi- talization, which can be facilitated by results of this study. After administering a cross-sectional questionnaire, Mitchell18 found that preoperative and postoperative information has a statistically significant positive associa- tion with patients being “fully prepared for all events during home recovery.” Ultimately, improved patient sat- isfaction, an increasingly important quality measure, can be achieved once concrete, evidence-based goals are set and
patients meet these milestones within the expected time increments (http://www.mgma.com/Libraries/Assets/Key- Findings-PhysComp_FINAL-with-copyright.pdf, http:// www.cms.gov/Medicare/Quality-Initiatives-Patient-Assess ment-instruments/HospitalQualityInits/HospitalHCAHPS. html).
Postoperative recovery is a complex process that involves multiple domains19; those who are actually “recovering,” equate recovery to the absence of symptoms, and the return of their physical abilities to pretreatment baseline.20 Our study defined recovery based on the different domains of CARE and SF-12. The advantage of using an instrument such as CARE involves the ability to analyze recovery with respect to different phases. For example, patients can be informed that on average their pain and activity levels will be significantly altered at 2 but not at 4 weeks after this surgery. Moreover, their cognition and GI issues tend not to be affected and thus patients with sedentary jobs can plan to safely return to work 2 weeks after surgery. Of course, additional factors can affect this recovery and should be taken into consideration. For example, decrease in activity may reflect a combination of surgery-induced decreases in activity as well as limitations that are placed on patients by surgeons. Of note, all of our study patients were counseled to avoid strenuous exercise and heavy lifting for the first 3 weeks of recovery. Our study will aide surgeons in counseling patients before LA, specifically addressing the questions on how soon the patients will regain baseline physical, GI, and cognitive function as well as when to expect resolution of pain allowing for improved preparation of work and family obligations during recovery period.
The primary limitation to this study is a relatively small sample size from a single institution and a single high-volume adrenal surgeon. A larger number of patients from multiple institutions would allow for a better evaluation of clinical factors affecting recovery. Our study, however, is the first to evaluate patient-reported recovery after adrenalectomy and can be used as a reference point for future investigators. Sampling bias may also be present, but it should be noted that all English-speaking patients who underwent LA during the study period were offered enrollment.
CONCLUSIONS
This is the first report to assess the length and extent of postoperative recovery after LA using patient-reported HRQOL outcomes. Our results suggest that patients
Copyright @ 2016 Wolters Kluwer Health, Inc. All rights reserved.
require about 4 weeks to return to baseline activity, GI, and pain status after LA. Our findings can be used as a guide for surgeons to help improve preoperative patient counseling.
REFERENCES
1. Wang H, Wang C, Li C, et al. Comparison of laparoscopic adrenalectomy with open surgery for adrenal tumors. Kaoh- siung J Med Sci. 2009;25:438-444.
2. Wu C, Chiang Y, Chou C, et al. Comparative study of laparoscopic and open adrenalectomy. Chang Gung Med J. 2006;29:468-473.
3. Roman SA, Sosa JA, Park HS. Outcomes from 3144 adrenalectomies in the United States: which matters more, surgeon volume or specialty? Arch Surg. 2009;11:1060-1067.
4. Brunt LM. The positive impact of laparoscopic adrenalectomy on complications of adrenal surgery. Surg Endosc. 2002;16: 252-257.
5. Lee J. Open and laparoscopic adrenalectomy: analysis of the national surgical quality improvement program. J Am Coll Surg. 2008;206:953-959.
6. Filipponi S, Guerrieri M, Arnaldi G, et al. Laparoscopic adrenalectomy: a report on 50 operations. Eur J Endocrinol. 1998;138:548-553.
7. Testa MA, Simonson DC. Assessment of quality-of-life out- comes. N Engl J Med. 1996;334:835-840.
8. Hollenbeck BK, Dunn RL, Wolf JS, et al. Development and validation of the convalescence and recovery evaluation (CARE) for measuring quality of life after surgery. Qual Life Res. 2008;17:915-926.
9. Ware JE, Kosinski M, Keller SD. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34:220-233.
10. Kim SB, Williams SB, Cheng S, et al. Evaluation of patient- reported quality-of-life outcomes after renal surgery. Urology. 2012;79:1268-1273.
11. Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research infor- matics support. J Biomed Inform. 2009;42:377-381.
12. Iacobone M, Citton M, Viel G, et al. Adrenalectomy may improve cardiovascular and metabolic impairment and ameliorate quality of life in patients with adrenal incidentalo- mas and subclinical Cushing’s syndrome. Surgery. 2012;152: 991.
13. Iacobone M, Albiger N, Scaroni C, et al. The role of unilateral adrenalectomy in ACTH-independent macronodular adrenal hyperplasia (AIMAH). World J Surg. 2008;32:882-889.
14. Thompson SK, Hayman AV, Ludlam WH, et al. Improved quality of life after bilateral laparoscopic adrenalectomy for Cushing’s disease: a 10-year experience. Ann Surg. 2007;245: 790-794.
15. Feldman LS, Kaneva P, Demyttenaere S, et al. Validation of a physical activity questionnaire (CHAMPS) as an indicator of postoperative recovery after laparoscopic cholecystectomy. Surgery. 2009;146:31-39.
16. Tran TT, Kaneva P, Mayo NE, et al. Short-stay surgery: what really happens after discharge? Surgery. 2014;156:20-27.
17. Schroeck FR, Krupski TL, Sun L, et al. Satisfaction and regret after open retropubic or robot-assisted laparoscopic radical prostatectomy. Eur Urol. 2008;54:785-793.
18. Mitchell M. Home recovery following day surgery: a patient perspective. J Clin Nurs. 2015;24:415-427.
19. Lee L, Tran T, Mayo NE, et al. What does it really mean to “recover” from an operation? Surgery. 2013;155:211.
20. Kleinbeck SV, Hoffart N. Outpatient recovery after laparo- scopic cholecystectomy. AORN J. 1994;60:394. 397.