The safety of laparoscopic cholecystectomy (LC) in patients ≥65 years of age requires further investigation of postoperative outcomes before it becomes more widely accepted as a safe technique. The advantages of using LC versus open cholecystectomy (OC) in elderly patients were analyzed using propensity score matching. The demographics, cholecystitis severity, comorbidities, complications, and admission and discharge Barthel Index (BI) scores of patients with benign gallbladder diseases were analyzed. Outcomes were analyzed by age, length of stay (LOS), total charges (TCs), BI improvement, and postoperative complications. OC, which was indicated in severe disease cases, increased hospital resource use and caused more complications than LC, but did not improve BI. Advanced age and OC resulted in greater LOS and TCs and was the best indicator of BI deterioration. Whenever possible, surgeons should use LC in elderly patients to minimize postoperative complications and allow them to regain a good quality of life.
We live in an era of surgical innovation that has seen the development and expansion of various types of laparoscopic surgery in which the incisions made are increasingly small. It is well established that laparoscopic surgery, in comparison with more traditional methods, results in fewer post-operative complications and leads to earlier patient mobility and recovery of the normal activities of daily life [
Care-related outcomes such as mortality and post-operative complications have been studied extensively, but to the best of our knowledge, there have been no studies measuring functional changes in elderly patients undergoing cholecystectomies [
Using a Japanese administrative database from fiscal year (FY) 2004 to 2008, we examined variation in the use of OC in patients ≥65 years of age. We analyzed the advantages of using LC instead of OC by propensity scoring in which we concurrently estimated the effects of age and OC on hospital resource use, postoperative complications and functional changes in recovering patients.
This retrospective study used both a Japanese administrative database and claim data that were incorporated into the Ministry of Health, Labour and Welfare (MHLW) database as well as our own research project that was designed to develop a Japanese case-mix classification system. Eighty-two academic and 1,346 community hospitals were enrolled in 2008. Anonymous health insurance claims data with detailed clinical information had been collected annually for this database for 4–6 months beginning July 1, 2002, and the information was provided to our research team. The database contained the date and quantity of care provided during hospitalization; therefore, it was used to assess hospital performance and payments [
Our database included a total of 8,010,361 possible patients from the 1,006 hospitals that have participated voluntarily in our research project from 2004 to 2008. In this group, we identified 13,709 cholecystectomy patients (11,677 LC and 2,032 OC) who were treated for benign gallbladder diseases in 122 hospitals participating in our project for five consecutive years. From the group of 13,709 cholecystectomy patients, 4916 were aged ≥ 65 and were enrolled in this study. Our project was approved by the ethical committee of the University of Occupational and Environmental Health, Fukuoka, Japan.
Study variables were as follows: age, sex, use of an ambulance (in an emergency situation), discharge outcome, discharge destination (to their home or other facility), presence of inflammation (as an indicator of the principal diagnosis), comorbidities, physical condition, and functional status at admission and discharge expressed by the Barthel Index (BI) score, biliary or procedure-related complications, use of IOC, pre- and/or postoperative ERCP or BDI, and hospital teaching status (community or academic hospital).
Study patients were stratified into three age groups: 65–74, 75–84, and ≥85 years. Diagnoses were classified according to the International Classification of Disease 10th version (ICD code). A maximum of four comorbid conditions or four complications per patient were recorded in the database. To assess the severity of pre-existing comorbid conditions, we used the Charlson Comorbidity Index (CCI) [
Preoperative percutaneous gallbladder and CBD drainage, endoscopic dilatation and sphincterotomy of the ampulla of Vater, stone extraction, and stent insertion were classified as BDIs. ERCP was also examined as a factor independent of BDI. Patients who underwent conversion from LC to OC were classified as OC cases because of the lack of conversion information at this time.
We calculated the operating room time; this time included induction of general anesthesia, insertion of the epidural anesthesia where applicable, preparation for video-monitoring, and extubation of the endotracheal tube as well as the skin-to-skin time. We also measured length of stay (LOS) and total charges (TCs) billed during admission. TC is considered to be a good estimate of healthcare costs [
Frequencies and proportions for categorical data for OC and LC cases were compared by Fisher’s exact test. Continuous variables were compared using analysis of variance. The variations in LOS, TC, and the operating room time between OC and LC were also indicated in the box chart. Logistic regression was used to evaluate the OC-associated study variables. To reduce possible selection bias for cases indicating OC, we defined propensity score paired-matched cohorts and compared operating room time, resource use, and BI improvement score in each of the LC and OC groups [
Out of a total of 4,916 cholecystectomy patients, there were 3,692 LC patients from 122 hospitals and 1,224 OC patients from 117 hospitals. Of the LC patients, 1,071 (29.0%) were treated in 35 hospitals and 295 (24.1%) OC patients were treated in 34 academic hospitals. Twenty-one patients (two LC and 19 OC) were deceased and excluded. Older patients and those with greater CCI or acute gallbladder inflammation underwent OC more frequently. Preoperative ERCP or BDIs were performed more often in OC. Operating room time, LOS, TC, BI improvement score and complications were higher in OC, whereas BI scores at admission and discharge were lower (Table
Patient characteristics, care process, and outcomes according cholecystectomy procedure (
Aged 65 years or more | ||||
Laparoscopic cholycystectomy (3692) | Open cholecystectomy (1224) | |||
Number of patients; community, academic | 2621, 1071 | 929, 295 | ||
Number of hospitals; community, academic | 87, 35 | 83, 34 | ||
Age | Mean | 72.7 [5.6] | 75.2 [6.5] | |
65–74 years | 2461 (66.7) | 619 (50.6) | <.001 | |
75–84 years | 1104 (29.9) | 485 (39.6) | ||
≥85-years | 127 (3.4) | 120 (9.8) | ||
Sex | ||||
Male | 1706 (46.2) | 741 (60.5) | <.001 | |
Ambulance | ||||
Used | 120 (3.3) | 172 (14.1) | <.001 | |
Outcome | ||||
Mortality | 2 (0.1) | 19 (1.6) | <.001 | |
Destination | ||||
not at home | 101 (2.7) | 97 (7.9) | <.001 | |
Severity | ||||
Acute | 493 (13.4) | 520 (42.5) | <.001 | |
Chronic or others | 1168 (31.6) | 405 (33.1) | ||
Charlson comorbidity index | ||||
1 | 670 (18.1) | 262 (21.4) | <.001 | |
2 | 272 (7.4) | 152 (12.4) | ||
3 | 87 (2.4) | 74 (6.0) | ||
Preoperative ERCP only | 131 (3.5) | 67 (5.5) | .003 | |
Preoperative BDI | 372 (10.1) | 270 (22.1) | <.001 | |
IOC | 132 (3.6) | 28 (2.3) | .028 | |
Study complication | 351 (9.5) | 175 (14.3) | <.001 | |
Acute pancreatitis | 35 (0.9) | 14 (1.1) | ||
Peritonitis | 18 (0.5) | 24 (2.0) | ||
Bowel obstruction | 4 (0.1) | 8 (0.7) | ||
Change of BI | ||||
Deterioration | 55 (1.5) | 28 (2.3) | <.001 | |
No change | 2669 (72.3) | 741 (60.5) | ||
Improvement | 130 (3.5) | 123 (10) | ||
Teaching status | ||||
Academic | 1071 (29) | 295 (24.1) | .001 | |
BI at admission | 95.6 | 86.5 | <.001† | |
BI at discharge | 96.5 | 90.9 | <.001† | |
BI improvement | 0.9 | 4.4 | <.001† |
Resource use according to cholecystectomy approach.
Advanced age (≥75 years), male sex, transport by ambulance to the hospital, presence of inflammation, and CCI of ≥2 were significant indicators for OC, but higher BI score at admission and surgery at an academic hospital was associated with less indication for OC (Table
Variables associated with indications of open cholecystectomy (OC).
Odds ratio | |||
Age (65–74 years) | |||
75–84 years | 1.481 | ||
≥85-years | 2.446 | ||
Gender | |||
Male | 1.823 | ||
Ambulance | |||
used | 2.257 | ||
Severity (for no inflammation) | |||
Acute | 4.718 | ||
Chronic | 1.929 | ||
Charlson comorbidity index (for zero) | |||
1 | 1.235 | ||
2 | 2.079 | ||
3 | 2.085 | ||
BI at admission | 0.993 | ||
Preoperative ERCP | 1.408 | ||
Preoperative BDI | 1.197 | ||
Teaching status (for community) | |||
Academic | 0.757 | ||
Hosmer Lemeshow goodness of model fit. | 0.339 |
ERCP: endoscopic retrograde cholangiopancreatography
In the propensity score-paired matching cohorts, longer operating room time, longer LOS, and higher TCs were observed for OC, but the BI improvement score did not differ significantly between OC and LC for these parameters (Table
Patient characteristics, care process, and outcomes according to cholecystectomy procedure after propensity score matching (
Laparoscopic cholecystectomy (775) | Open cholecystectomy (775) | |||
---|---|---|---|---|
Total | 616(C), 159(A) | 610(C), 165(A) | ||
Number of hospitals; community, academic | 77(C), 23(A) | 79(C), 32(A) | ||
Age | Mean | 73.9 [6.1] | 74.1 | |
65–74 years | 435 (56.1) | 441 (56.9) | .856 | |
75–84 years | 291 (37.5) | 290 (37.4) | ||
≥85-years | 49 (6.3) | 44 (5.7) | ||
Sex | ||||
Male | 449 (57.9) | 462 (59.6) | .502 | |
Ambulance | ||||
Used | 59 (7.6) | 66 (8.5) | .514 | |
Destination | ||||
not at home | 25 (3.2) | 44 (5.7) | .019 | |
Severity | ||||
Acute | 256 (33) | 259 (33.4) | .966 | |
Chronic or others | 294 (37.9) | 289 (37.3) | ||
Charlson comorbidity index | ||||
1 | 169 (21.8) | 162 (20.9) | .915 | |
2 | 97 (12.5) | 91 (11.7) | ||
3 | 37 (4.8) | 39 (5) | ||
Preoperative ERCP | 55 (7.1) | 44 (5.7) | .253 | |
Preoperative BDI | 153 (19.7) | 147 (19) | .700 | |
IOC | 15 (1.9) | 17 (2.2) | .721 | |
Complication | 75 (9.7) | 93 (12) | .141 | |
Acute pancreatitis | 9 (1.2) | 7 (0.9) | ||
Peritonitis | 4 (0.5) | 14 (1.8) | ||
Bowel obstruction | 3 (0.4) | 3 (0.4) | ||
Change of BI | ||||
Deterioration | 14 (1.8) | 24 (3.1) | .054 | |
No change | 692 (89.3) | 662 (85.4) | ||
Improvement | 69 (8.9) | 89 (11.5) | ||
Teaching status | ||||
Academic | 159 (20.5) | 165 (21.3) | .708 | |
BI at admission | 90.7 [24.2] | 90.5 | ||
BI at discharge | 93.3 | 93.6 | ||
BI improvement | 2.6 [12.7] | 3.2 |
BDI: bile duct intervention. IOC: intraoperative cholangiography
Resource use according to cholecystectomy approach after propensity score matching.
Patients ≥75 years of age had longer LOS, and those ≥85 years of age had higher TCs. Patients between 75 and 84 years of age had a lower BI improvement score. OC was significantly associated with longer operating room time and LOS, and higher TCs, but not with BI improvement score. Complications were associated with greater LOS, TCs and less BI improvement scores (Table
Variables associated with length of stay (LOS), total charge (TC), operating room time (min), and Barthel index (BI) improvement.
LOS | TC | Operating room time | BI improvement | |||||
Estimation | 95% CI | Estimation | 95% CI | Estimation | 95% CI | Estimation | 95% CI | |
Intercept | 11.6 | [8.2–14.9] | 6937 | [5925–7949] | 151.5 | [132.7–170.3] | 37.4 | [34.0–40.9] |
Age (for 65–74 years) | ||||||||
75–84 years | 2.9 | [0.2–5.6] | 620 | [−196–1436] | 1.2 | [−13.1–15.4] | −6.1 | [−8.8–−3.3] |
85-years | 1.9 | [0.6–3.2] | 483 | [86–880] | −2.3 | [−9.2–4.6] | −0.4 | [−1.7–1.0] |
Male | −0.1 | [−1.4–1.2] | 174 | [−212–560] | 6.0 | [−0.7–12.7] | 1.3 | [0.0–2.6] |
Ambulance | 3.1 | [0.8–5.5] | 1487 | [782–2193] | 6.3 | [−6.0–18.7] | 3.1 | [0.7–5.5] |
Severity (for noinflammation) | ||||||||
Acute | 2.5 | [0.9–4.1] | 1032 | [544–1519] | 8.2 | [−0.4–16.9] | −0.3 | [−2.0–1.3] |
Chronic or others | 3.8 | [2.1–5.6] | 1690 | [1167–2213] | 18.3 | [9.0–27.7] | 0.8 | [−1.0–2.6] |
Charlson comorbidity index (for zero) | ||||||||
1 | 7.3 | [4.4–10.2] | 2618 | [1737–3499] | 13.4 | [−1.9–28.8] | −1.0 | [−3.9–2.0] |
2 | 2.3 | [0.3–4.2] | 799 | [207–1391] | −4.8 | [−15.1–5.6] | −0.9 | [−2.9–1.1] |
3 | 1.7 | [0.1–3.3] | 296 | [−178–770] | −6.0 | [−14.3–2.3] | 0.4 | [−1.2–2.0] |
BI at admission, one point more | −0.046 | [−0.073–−0.018] | −22 | [−31–−14] | −0.013 | [−0.161–0.135] | −0.388 | [−0.416–−0.360] |
Preoperative ERCP only | 8.2 | [5.7–10.8] | 2147 | [1371–2924] | 8.6 | [−5.0–22.2] | 2.2 | [−0.5–4.8] |
Preoperative BDI | 13.7 | [12.0–15.3] | 5480 | [4979–5982] | 12.0 | [3.1–20.8] | 0.9 | [−0.8–2.6] |
Approach (for laparoscopic cholecystectomy) | ||||||||
Open cholecystectomy | 7.9 | [6.6–9.3] | 1635 | [1228–2041] | 17.5 | [10.1–24.9] | 0.5 | [−0.9–1.9] |
IOC | 0.2 | [−4.3–4.7] | 793 | [−563–2149] | 7.2 | [−17.2–31.6] | −0.8 | [−5.4–3.8] |
Complication | 4.7 | [2.6–6.7] | 1421 | [806–2036] | −3.2 | [−5.3–−1.1] | ||
Teaching status (for community) | ||||||||
Academic | 0.6 | [−1.7–2.9] | 427 | [−217–1071] | 30.7 | [15.5–46] | −1.5 | [−4.0–1.0] |
Akaike informationcriteria | 12199 | 29920 | 17355 | 12272 |
ERCP: endoscopic retrograde cholangiopancreatography. IOC: intraoperative cholangiography.
A risk of complications was observed in OC [odds ratio (OR) 1.285; 95% confidence interval (CI): 0.927–1.782] and patients with CCI ≥ 3 [OR: 1.894; 95% CI: 1.001–3.583]. The risk of complications was not related to age or BI at admission. Age, CCI ≥ 3, and complications were associated with BI deterioration: 75–84 years [OR: 2.908; 95% CI: 1.369–6.173], ≥85 years [OR: 3.998; 95% CI: 1.261–12.678], CCI ≥ 3 [OR: 3.998; 95% CI: 1.364–11.717], and complications [OR: 3.729; 95% CI: 1.768–7.865]. OC was not an independent indicator of BI deterioration (Table
Variables associated with complications and Barthel index (BI) deterioration.
Complication | BI deterioration | ||||
Odds ratio | [95% CI] | Odds ratio | [95% CI] | ||
Age ( 65–74 years) | |||||
75–84 years | 1.232 | [0.874–1.737] | 2.908 | [1.369–6.173] | |
≥85-years | 1.147 | [0.561–2.348] | 3.998 | [1.261–12.678] | |
Gender | |||||
Male | 0.877 | [0.626–1.229] | 0.430 | [0.213–0.869] | |
Ambulance | |||||
used | 1.553 | [0.916–2.633] | 3.195 | [1.326–7.700] | |
Severity (for no inflammation) | |||||
Acute | 1.665 | [1.077–2.574] | 0.952 | [0.392–2.315] | |
Chronic | 1.215 | [0.786–1.877] | 0.957 | [0.410–2.234] | |
Charlson comorbidity index | |||||
1 | 1.258 | [0.848–1.866] | 1.171 | [0.490–2.799] | |
2 | 0.963 | [0.555–1.671] | 1.599 | [0.567–4.512] | |
3 | 1.894 | [1.001–3.583] | 3.998 | [1.364–11.717] | |
BI at admission | 1.003 | [0.996–1.010] | 1.004 | [0.99–1.017] | |
Preoperative ERCP | 1.405 | [0.779–2.533] | 0.819 | [0.185–3.632] | |
Preoperative BDI | 0.923 | [0.607–1.404] | 0.605 | [0.241–1.516] | |
Approach (for laparoscopic cholecystectomy) | |||||
Open cholecystectomy | 1.285 | [0.927–1.782] | 1.729 | [0.871–3.432] | |
IOC | 0.586 | [0.137–2.508] | 2.65 | [0.572–12.279] | |
Complication | 3.729 | [1.768–7.865] | |||
Teaching status (for community) | |||||
Academic | 1.989 | [1.389–2.849] | 0.899 | [0.389–2.082] | |
Hosmer Lemeshow goodness of model fit. | 0.266 | 0.810 |
The present study was conducted to compare the advantages of LC versus OC in older patients in relation to changes in physical condition and ability to function. OC was employed more often in patients ≥75 years of age and those with greater CCI or the presence of gallbladder inflammation. Preoperative ERCP or BDIs were required more often in OC. Multivariate analysis of the propensity score matching cohorts revealed that LC had the advantage of fewer complications, shorter LOS, and lower TCs compared with OC. Operating room time and resource use were greater in OC. Neither cholecystectomy procedure caused significant variations in BI improvement scores or BI deterioration. Age did not determine the complications, but advanced age and complications were independent indicators of the functional recovery.
We observed an age disparity in the use of OC and LC in the older patients. Compared with the 75–84 year-old group, OC was used more frequently than LC for patients ≥85 years of age. This corresponds to the findings of a Swedish community study of cholecystectomies by Rosenmüller et al. [
Previous studies have confirmed the advantage of LC only in terms of mortality and complications; our study adds new and additional information concerning post-operative recoveries. In an aging population, major care-related outcomes related to the change in activity of daily life should also be considered. Kugler et al. estimated the functional recovery by measuring the change in BI score combined with information from the Hessian Stroke Data Bank [
Since a randomized study for the elderly might be difficult to perform and unethical in that it would also depend on patient comorbidities, we constructed the propensity score matching cohorts using the administrative database. This kind of study might help surgeons make the right decision as to which factors are associated with functional recovery as well as which procedure is best for the elderly patient in actual clinical situations. Knowledge of functional changes would also contribute to the determination of healthcare policies for the elderly in the medically advanced G7 countries, where an ever-increasing number of aging patients require expensive surgical innovations [
The extra costs of surgical innovations that promote earlier functional recovery would be offset by the overall benefits to the healthcare system derived from reducing LOS. Those costs should incorporate additional procedures such as the study BDIs that allow for the completion of laparoscopic surgery without conversion to OC. We attempted to address the concerns about treatment options for elderly patients by overcoming any selection bias as comprehensively as possible. Preoperative BDI, which is an indicator of disease severity, does not always appear to influence post-operative functional status, but the occurrence of post-operative complications appears to be a factor influencing functional recovery. As complications were not necessarily correlated with age, the key to achieving favorable outcomes in elderly patients is to manage post-operative complications [
Several limitations to our study should be discussed. The study period was limited to 4 months which might diminish our ability to generalize our results. However, our larger sample size and use of propensity scoring appeared to improve the validity of this study. Because the MHLW extended the study period to 12 months from FY 2010, use of this extensive database will expand the number of cases analyzed and overcome the initial limitation. A second point is that the duration of hospitalization in Japan is generally 2-3 times longer than that in Western countries [
Our study investigated the quality of cholecystectomy care in patients ≥65 years of age using an administrative database and propensity score-paired matching analysis. The mix of patient cases explained the variation in use of cholecystectomy. After correcting for selection bias and relevant covariates, the LC method remained advantageous over OC in terms of fewer complications and lower resource use. Patients' functional status was not influenced by the type of cholecystectomy, but was affected by advanced age and complications. Surgeons should use LC in the elderly as much and as prudently as possible by planning the necessary preoperative treatment strategy and obtaining the necessary skills to complete LC without conversion to OC.
The authors have no competing conflicts of interest to declare.
This study was funded in part by Grants-in-Aid for Research on Policy Planning and Evaluation (Japanese Ministry of Health, Labour and Welfare, H19 Seisaku-sitei 001).