Surg Endosc (2009) 23:2702–2707 DOI 10.1007/s00464-009-0480-9
Treatment of gallbladder disease during operations Iraqi Freedom and Enduring Freedom Chad R. Edwards Æ James P. Dolan Æ Raymond Fang Æ Richard E. Standaert
Received: 9 July 2008 / Accepted: 11 February 2009 / Published online: 8 July 2009 Ó Springer Science+Business Media, LLC 2009
Abstract Background We examined the outcome after treatment for gallbladder disease in deployed military service members and the impact of instituting a clinical pathway to expedite return to duty (RTD). Methods A retrospective chart review of 97 medically evacuated patients with gallbladder disease was carried out. These patients were evacuated from the field to Landstuhl Regional Medical Center (LRMC), Germany, between March 2003 and November 2004. In October 2003, a clinical pathway was established to facilitate returning these deployed patients back to their combat units. These service members were compared with 90 local patients who underwent the same surgery during the study period.
The authors received no outside funding, payments, nor other benefits from a commercial entity. The views expressed in this paper are those of the authors and do not reflect the official policy of the Department of Defense or the United States Government. Presented at the 76th annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, April 9–12, Philadelphia, PA, USA. C. R. Edwards J. P. Dolan General Surgery Service, Keesler Medical Center, Keesler AFB, MS, USA C. R. Edwards e-mail:
[email protected] R. Fang R. E. Standaert General and Specialty Surgery Service, Landstuhl Regional Medical Center, Landstuhl, Germany R. E. Standaert (&) General and Specialty Surgery Clinic (Ward 14A), LRMC CMR 402, 09180 Landstuhl, Germany e-mail:
[email protected]
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Results Twenty-nine patients were treated before the implementation of the clinical pathway. Of those, five had complications, five were converted to open, and 52% returned to their deployed units. After the clinical pathway was established, there were no complications (p = 0.023), two were converted to open (p = 0.002), and 84% returned to duty (p = 0.002). The Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) service members had delayed presentations for definitive treatment. When compared with the local patient group, OIF/OEF surgical cases were more often male (78 vs. 32%, p \ 0.001), younger (average 31 vs. 35 years, p \ 0.001), and associated with longer operative times (89 vs. 52 min, p \ 0.001), and had higher conversion rate to open (7.2 vs. 2.2%, p = 0.17) and higher major complication rate (5.1 vs. 0%, p = 0.06). Time to operation and final pathologic diagnosis were significantly different between the two groups. Conclusions Gallbladder surgery can be performed in a delayed manner in the deployed service member, although with a significantly higher morbidity as compared with the local population. We suggest that changes in the immediate treatment and transportation of these service members should occur at the theater level. The use of a clinical pathway facilitates the rapid RTD of soldiers diagnosed with gallbladder disease. Keywords Gallbladder disease Cholecystectomy Postoperative convalescence Clinical pathway Return to duty Military medicine Operation Iraqi Freedom Operation Enduring Freedom Abbreviations LRMC Landstuhl Regional Medical Center OIF/OEF Operations Iraqi Freedom and Enduring Freedom
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RTD TRAC2ES DNBI CONUS
Return to duty TransCom and Control Evacuation System Disease and nonbattle injuries Continental USA
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expeditious manner, thereby decreasing the time a combat unit is without key personnel.
Methods Symptomatic cholelithiasis and cholecystitis are disease processes frequently seen in the general population of developed countries. However, surgical treatment and postoperative convalescence pose a unique problem for military personnel deployed overseas, sometimes to isolated geographical areas. Prior to the laparoscopic era, surgical intervention in deployed service members required a major open procedure that effectively removed the patient from the theater of operations for an extended period of time [1]. Currently, treatment of nonemergent biliary tract disease among the deployed military force occurs at a facility outside of theater of operation. Landstuhl Regional Medical Center (LRMC) is the largest US military medical facility located outside of the USA and acts as the only tertiary referral center for all US and coalition forces deployed in support of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF). A critical wartime mission of the medical corps is to conserve military fighting strength by expeditiously returning service members with nontraumatic surgical disease to their operational units within the combat zone in order to increase the effectiveness of our fighting force. In addition to providing medical and surgical support to the operations in theater, LRMC provides medical treatment for the largest American population located outside of the continental USA (CONUS), which includes active duty military members, their families, and civilians with a catchment area of 150,000 people throughout Europe, Africa, and Western Asia. These two distinct medical missions are tended to simultaneously. The use of clinical pathways has been shown to effectively decrease postoperative hospital stays, improve efficiency of clinical resources, and confer an economic benefit to the medical treatment facility [2, 3]. A clinical pathway had not been established at LRMC for deployed personnel transferred for surgical evaluation and treatment from the theater of operations prior to October 2003. We theorized that such a pathway could help expedite the return of soldiers to their units and help ameliorate the loss of unit personnel secondary to battle and nonbattle injuries. In this study, we evaluated our treatment of gallbladder disease among service members deployed in support of OIF/OEF over a 20-month period. We compared this population to the local patient population who presented for treatment during the same period to identify differences in outcome. Furthermore, we implemented and analyzed the effectiveness of a surgical clinical pathway designed to safely return a deployed service member to duty in a more
The study protocol was reviewed and approved by the Walter Reed Army Medical Center Institutional Review Board. A retrospective chart review of 187 patients who were treated for biliary disease at LRMC between March 2003 and November 2004 was performed. Ninety-seven patients were transferred to LRMC from military operations in support of OIF/OEF and 90 patients were treated from the catchment area of LRMC during the same time frame. Information was collected on age, gender, date of admission, procedure, specimen pathology, and discharge. Additionally, operative and postoperative complications, operative time, and time to return to duty or recovery were also reviewed for both OIF/OEF and local patients. Patients from the local area were referred to the general surgery clinic from the primary care provider or the emergency room where they were evaluated by a general surgery staff physician. Those requiring surgical treatment were then scheduled for surgery. Patients who were deployed in support of OIF/OEF were initially evaluated by physicians at the deployed location. If biliary disease was diagnosed, they were then transported to LRMC by means of the military medical evacuation system for treatment. Upon arrival, a general surgery staff physician evaluated the service member to confirm the diagnosis and reviewed or obtained any required laboratory tests or radiographic studies. Prior to October 2003, some deployed soldiers were treated at LRMC, while others were returned to their home stations in the USA for surgical treatment. Likewise, the postoperative convalescence and disposition of those undergoing surgical treatment at LRMC also varied, with some eventually returning to duty and others returning to the USA. In October 2003, a clinical pathway for the treatment of biliary tract disease was initiated in an attempt to standardize the care of deployed military members who required surgical treatment (Table 1). Under this pathway,
Table 1 Comparison of treatment of BD in OIF/OEF patients before and after establishment of a clinical pathway Before pathway
After pathway
Evaluation
Nonurgent
Urgent
Time to surgery
Variable
Within 48 h
Surgeons
One
Two
Postoperative care
Nonstandardized
Standardized orders and patient instructions
Follow-up
Variable
7 and 14 days
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patients evacuated with biliary disease to LRMC were scheduled for surgery within 48 hours after admission and confirmation of diagnosis. Operations were performed on an inpatient basis because of the absence of family support for postoperative care. All general surgeons involved in the care of these patients had individually performed over 200 laparoscopic cholecystectomies as primary surgeon, and the procedure was performed by two surgeons using the standard four-trocar technique [4]. Cholangiography was not mandated for all cases but was performed in selected cases where common bile duct disease was suspected or imaged preoperatively, or where anatomy was clearly delineated. Conversion to open cholecystectomy was at the discretion of the primary surgeon based upon adequacy of surgical exposure, definition of the relevant anatomy, and possibility of intraoperative complication. Patients were returned to the inpatient ward postoperatively and subsequently discharged to military lodging when their surgeon judged them to be capable of self-care. The clinical pathway permitted patients up to 2 weeks convalescence, during which time they were evaluated by a surgeon on a weekly basis to determine if they were suitable for return to duty (RTD). In order to account for patient movement after treatment at LRMC, we tracked all deployed personnel using the TransCom and Control Evacuation System (TRAC2ES) database. By querying TRAC2ES, we could identify all patients medically evacuated from the combat zone and transported after treatment at LRMC. Collected data were summarized using Microsoft Excel (Microsoft Corp, Richmond, WA) and analyzed with SPSS 14.0 (SPSS Inc., Chicago, IL.). Conversion rate and complications were compared using Fisher’s exact test. Chisquare was used for comparison of other dichotomous data. Age and operative time were compared among the local population and deployed patients before and after implementation of the clinical pathway with one-way analysis of variance and Tukey’s post hoc test. Age and operative time for all groups was examined with Pearson correlation coefficient. A p value of \0.05 was considered statistically significant.
Results Between March 2003 to October 2004, 97 service members deployed in support of OIF/OEF were evacuated to Landstuhl Regional Medical Center for treatment of biliary disease. During the same period, 90 cases of gallbladder disease were treated from the local patient population (Fig. 1). When compared with the local population, the deployed patients were younger (average 31 vs. 35 years, range 20– 56 years, p \ 0.001) and predominately male (78 vs. 32%,
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Fig. 1 Comparison of patient characteristics and operative data between the two study groups
p \ 0.001). Operations were reported to be more difficult on deployed service members. In these cases there was increased operative time (89 vs. 52 min, p \ 0.001) and more conversions to open cholecystectomy (7 vs. 2, p = 0.172) in the military group. In the 97 deployed military members undergoing operative treatment, five operative complications occurred, compared with no complications in the local population group. This failed to reach statistical significance (p = 0.06). For deployed patients, time to operative intervention was significantly longer than for the local population of patients (average 14 vs. 1.5 days, respectively, p = 0.02). This was due to limitations in evacuation out of the combat zone and attempted nonsurgical treatments of biliary disease (BD) in theater. There were no mortalities in either group. Deployed military members had higher incidence of common bile duct stones than the local population of patients (5 vs. 1, p = 0.10). The single local patient with a common bile duct stone passed the stone spontaneously as confirmed on intraoperative cholangiogram. Of the five patients from the deployed group who had common bile duct stones, three required operative common bile duct exploration after unsuccessful endoscopic retrograde cholangiopancreatography (ERCP). The operative reports describe more severe inflammatory findings at time of operation in the OIF/OEF population. On pathologic examination, this group had significantly more acute disease when compared with the local population (29 vs. 14%, p = 0.02). There were no significant differences in prevalence of chronic cholecystitis or other biliary diagnoses between these two groups (Table 2). In October 2003, a clinical pathway for the treatment of biliary disease was implemented at LRMC (Table 1). The deployed patients who were treated prior to the implementation of the clinical pathway were significantly
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Table 2 Comparison of final pathology diagnosis between, and within, the two study groups Groups OIF/OEF
Local
p Value
Acute cholecystitis
28 (29%)
13 (14%)
0.02
Chronic cholecystitis
63 (65%)
67 (74%)
NS
6 (6%)
10 (11%)
NS
Other
Fig. 3 Return to duty rates for those OIF/OEF patients before and after establishment of a clinical pathway for treatment of BD
duct injury. Both of these patients were transferred back to the continental USA (CONUS) for further management. Three cases of pancreatitis occurred in patients who had undergone endoscopic retrograde cholangiopancreatography (ERCP) following laparoscopic cholecystectomies and all were evacuated to CONUS. Prior to developing a clinical pathway, 52% (15 of 29) were returned to their combat deployment unit following treatment. After implementation of a clinical pathway, 84% (57 of 68) of patients were able to return to their combat unit. This was a significant difference (p = 0.002) (Fig. 3).
Discussion
Fig. 2 Comparison of age and operative characteristics within the OIF/OEF cohort before and after establishment of a clinical pathway for treatment of BD
younger than those who were treated with the pathway (average 27 years, range 20–43 vs. 33 years, range 21– 50 years; p \ 0.001) (Fig. 2). Operative times for those before establishment of the pathway and after establishment of the pathway were similar. However, deployed patients treated prior to the implementation of the clinical pathway had significantly more conversions to an open procedure (5 vs. 2, p = 0. 023) and complications (5 vs. 0, p = 0.002). All complications in OIF/OEF patients occurred in those treated before the clinical pathway was in place. Specific complications included a cystic duct bile leak that required stent placement and one common bile
It is estimated that 10% of the population in Western society have gallstones. Of these, 1–3% will develop symptoms and require surgical treatment [5, 6]. We have found that biliary disease, principally in the form of cholecystitis, contributes to nonbattle mortality among service members currently serving abroad much as it has during other conflicts [7] and with equal proportion to that seen in the civilian population [5, 8]. Gallstone disease has traditionally been associated with females or older individuals with increased body mass, and low high-density lipoprotein levels [8]. This is in contrast to the military cohort of patients reported in this study who are predominantly younger, presumably active, males (Fig. 1). It is possible that the deployed environment may contribute to an increased incidence of gallbladder disease in this nontraditional population. Katsika and colleagues [9] investigated the contribution of genetic and environmental factors on the pathogenesis of symptomatic gallstones in a case–control study of over 43,000 twins. In their
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report, they found that environmental effects accounted for 62% of the phenotypic manifestations of disease among twins. Another report, investigating independent risk factors for gallstone formation in a region with high prevalence, suggested that low alcohol and high coffee consumption was a risk factor in a male population [8]. Likewise, Shaw reported a case of posttraumatic acute acalculous cholecystitis in a young service member [10]. Taken together, our findings suggest that there may be environmental triggers for cholecystitis in deployed service members that remain to be investigated. We found that a delay in evacuating service members from the combat zone to the tertiary care center influenced the difficulty of the operation. This was evident by the increased operating times and conversion rates among the OIF/OEF patients as compared with operations on patients from the local population. Others have found that male sex, severity of pathological status of gallbladder, and delay time between onset of symptoms and operation [11–13] are all risk factors for conversion to open operation. This can have a direct impact on morbidity and convalescence. In our group of deployed patients, 28 had pathological evidence of acute cholecystitis, and conversion to open cholecystectomy occurred in 7 patients, all of whom had severe inflammation. Evacuation to CONUS was necessary for all of these converted patients. Our findings agree with several prospective randomized trials [14–16] that indicate an increase in operative time, conversion rate, and hospital stay for operations on acute disease that are delayed beyond 3–4 days from onset of symptoms. Biliary disease is generally classified as a nonemergent condition for the purpose of aeromedical evacuation in order to accommodate more severely injured patients. This study suggests that this triage system adversely affects these patients’ access to appropriate definitive care for their BD which, in turn, has an impact on their eventual return to duty date. These patients may warrant more urgent triage and evacuation so that adequate treatment may be rendered, thereby decreasing morbidity and returning the patient to their combat unit in a more efficient manner. Laparoscopic cholecystectomy has proven to be of benefit to the military in terms of preserving fighting strength and reducing health care expenditure both in CONUS [17] and in the deployed environment [18]. However, there have been no investigations of the effects of a clinical pathway for gallbladder disease on clinical outcomes of operative intervention and return to duty rates among service members during times of war. Implementation of a clinical pathway for laparoscopic cholecystectomy has been shown to be successful, safe, satisfying for patients, and economically favorable [19, 20]. In our experience, after implementing a clinical pathway for service members undergoing laparoscopic cholecystectomy
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for gallbladder disease, there were significantly fewer complications and conversions to open procedures (Fig. 2), and 84% (57/68) of soldiers were able to complete their combat assignment as compared with only 52% (15/29) prior to the implementation of the clinical pathway (Fig. 3). The clinical pathway did ensure that patient care was standardized and allowed for care to be conducted in a single institution. Furthermore, the utilization of the clinical pathway eliminated the need to return service members to the CONUS for routine surgical care of BD. The use of a clinical pathway for treatment of BD increases operative success with significant reduction in operative risk and effectively enables deployed service members to return to their combat unit and complete their combat tour. Acknowledgment The authors would like to thank Mr. Walter Brehm for statistical analysis of our data.
References 1. Keus F, de Jong JA, Sooszen HG, van Laarhoven CJ (2006) Laparoscopic versus open cholecystectomy for patients with symptomatic cholelithiasis. Cochrane Database Syst Rev 4:CD006231 2. Topal B, Peeters G, Verbert A, Penninckx F (2007) Outpatient laparoscopic cholecystectomy: clinical pathway implantation is efficient and cost effective and increases hospital bed capacity. Surg Endosc 21:1142–1146 3. Calland JF, Tanaka K, Foley E, Bovbjerg VE, Markey DW et al (2001) Outpatient laparoscopic cholecystectomy: patient outcomes after implementation of a clinical pathway. Ann Surg 233:704–715 4. Nathanson LK, Shimi S, Cuschieri A (1991) Laparoscopic cholecystectomy: the Dundee technique. Br J Surg 78:155–159 5. Indar AA, Beckingham IJ (2002) Acute cholecystitis. Br Med J 325:639–643 6. Saboe GW, Slauson JW, Johnson R, Loecker TH (1995) The aeromedical risk associated with asymptomatic cholelithiasis in USAF pilots and navigators. Aviat Space Environ Med 66:1086– 1089 7. Blood CG, Jolly R (1995) Comparison of disease and nonbattle injury incidence across various military operations. Mil Med 160:258–263 8. Volzke H, Baumeister SE, Alte D, Hoffman W et al (2005) Independent risk factors for gallstone formation in a region with high cholelithiasis prevalence. Digestion 71:97–105 9. Katsika D, Grjibovski A, Einarsson C, Lammert F, Lichtenstein P, Marschall HU (2005) Genetic and environmental influences on symptomatic gallstone disease: a Swedish study of 43,141 twin pairs. Hepatology 41:1138–1143 10. Shaw RC (1970) Post-traumatic acute acalculous cholecystitis in young males. Mil Med 135:210–214 11. Russell JC, Walsh SJ, Reed-Fourquet L, Mattie A, Lynch J (1998) Symptomatic cholelithiasis: a different disease in men? Connecticut Laparoscopic Cholecystectomy Registry. Ann Surg 227:195–200 12. Kitano S, Matsumoto T, Aramaki M, Kawano K (2002) Laparoscopic cholecystectomy for acute cholecystitis. J Hepatobiliary Pancreat Surg 9:534–537 13. Dolan JP, Diggs BS, Sheppard BC, Hunter JG (2005) Ten-year trend in the national volume of bile duct injuries requiring operative repair. Surg Endosc 19:967–973
Surg Endosc (2009) 23:2702–2707 14. Lo CM, Liu CL, Fan ST, Lai EC, Wong J (1998) Prospective randomized study of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Ann Surg 227:461–467 15. Chandler CF, Lane JS, Ferguson P, Thompson JE, Ashley SW (2000) Prospective evaluation of early versus delayed laparoscopic cholecystectomy for treatment of acute cholecystitis. Am Surg 66:896–900 16. Pessaux P, Tuech JJ, Derouet N, Rouge C, Regenet N, Arnaud JP (2000) Laparoscopic cholecystectomy in the elderly: a prospective study. Surg Endosc 14:1067–1069 17. O’Reilly MJ, Mooney MJ, Modesto V, Byrne M (1991) Laparoscopic cholecystectomy: use and preparation for Operation Desert Shield. Surg Laparosc Endosc 1:50–51
2707 18. Paul MF, Kim D, Tylka BL, Crabtree TG, Drost T et al (1994) Laparoscopic surgery in a mobile army hospital deployed to the former Yugoslavia. Surg Laparosc Endosc 4:441–447 19. Calland JF, Tanaka K, Foley E, Bovbjerg VE, Markey DW et al (2001) Outpatient laparoscopic cholecystectomy: patient outcomes after implementation of a clinical pathway. Ann Surg 233:704–715 20. Irizarry JM, Graham MH, Cordts PR (1999) Use of a critical pathway to move laparoscopic cholecystectomy to the ambulatory surgery arena. Mil Med 164:531–534
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