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2.
Isr Med Assoc J ; 21(5): 330-332, 2019 May.
Article in English | MEDLINE | ID: mdl-31140225

ABSTRACT

BACKGROUND: Selective management of stable patients with anterior abdomen stab wounds (AASWs) has become a gold standard management approach throughout the world. Evidenced-based options for supporting selective management include clinical follow-up, local wound exploration with or without diagnostic peritoneal lavage, diagnostic laparoscopy, and abdominal computerized tomography. The presence of multiple AASWs might signify a more aggressive attack and limit the safety of a selective management approach. OBJECTIVES: To evaluate whether multiple AASWs are associated with an increased risk of intra-abdominal injury requiring emergency surgery. METHODS: We retrospectively reviewed all AASW patients admitted to Assaf Harofeh Medical Center, Zerifin, Israel, and Hillel Yaffe Medical Center in Hadera, Israel, from 2007 to 2015. Patients were divided into two groups based on the number of stab wounds: single or multiple. Data were coded for demographics, severity of injury, presence of intra-abdominal injury, laparotomy rate, length of hospital stay (LOS), length of stay in the intensive care unit (LICU), and survival. RESULTS: The study included 169 patients. Of these, 143 patients had a single AASW and 26 had multiple AASWs. There were no differences between the groups regarding demographics, severity of injury, intra-abdominal penetration, specific organ injury, LOS, or LICU. There was no difference in the percentage of patients requiring laparotomy. The overall mortality was 2.36% (4/169). There was no significant difference in the mortality rate between the groups (P = 0.11). CONCLUSIONS: The presence of multiple AASWs is not a risk factor for increased frequency and severity of intra-abdominal injury.


Subject(s)
Abdominal Injuries , Wounds, Stab , Abdominal Injuries/diagnosis , Abdominal Injuries/mortality , Abdominal Injuries/therapy , Adult , Female , Humans , Injury Severity Score , Intensive Care Units/statistics & numerical data , Israel/epidemiology , Laparoscopy/methods , Laparotomy/methods , Laparotomy/statistics & numerical data , Length of Stay/statistics & numerical data , Male , Mortality , Patient Care Management/methods , Patient Care Management/standards , Peritoneal Lavage/methods , Retrospective Studies , Risk Assessment/methods , Risk Factors , Tomography, X-Ray Computed/methods , Wounds, Stab/diagnosis , Wounds, Stab/mortality , Wounds, Stab/therapy
3.
Eur J Trauma Emerg Surg ; 45(5): 865-870, 2019 Oct.
Article in English | MEDLINE | ID: mdl-30264328

ABSTRACT

BACKGROUND: Extremities are commonly injured following bomb explosions. The main objective of this study was to evaluate the prevalence of hemorrhagic shock (HS) in victims of explosion suffering from extremity injuries. METHODS: Retrospective study based on a cohort of patient records maintained in one hospital's mass casualty registry. RESULTS: Sixty-six victims of explosion who were hospitalized with extremity injuries were identified and evaluated. Sixteen (24.2%) of these were hemodynamically unstable during the first 24 h of treatment. HS could be attributed to associated injuries in seven of the patients. In the other nine patients, extremity injury was the only injury that could explain HS in seven patients and the extremity injury was a major contributor to HS together with another associated injury in two patients. In those 9 patients, in whom the extremity injury was the sole or major contributor to HS, a median of 10 (range 2-22) pRBC was transfused during the first 24 h of treatment. Six of the nine patients were in need of massive transfusion. Fractures in both upper and lower extremities, Gustilo IIIb-c open fractures and AIS 3-4 were found to be risk factors for HS. CONCLUSIONS: Ample consideration should be given to patients with extremity injuries due to explosions, as these may be immediately life threatening. Tourniquet use should be encouraged in the pre-hospital setting. Before undertaking surgery, emergent HS should be considered in these patients and prevented by appropriate resuscitation.


Subject(s)
Blast Injuries/physiopathology , Hemorrhage/physiopathology , Mass Casualty Incidents/mortality , Shock, Hemorrhagic/mortality , Terrorism , Trauma Centers , Adolescent , Adult , Blast Injuries/complications , Blast Injuries/therapy , Bombs , Child , Female , Hemodynamics , Hemorrhage/complications , Hemorrhage/surgery , Humans , Injury Severity Score , Israel/epidemiology , Male , Middle Aged , Retrospective Studies , Tourniquets , Young Adult
4.
J Surg Educ ; 75(3): 688-696, 2018.
Article in English | MEDLINE | ID: mdl-28867584

ABSTRACT

OBJECTIVE: Assessment of the effect of the collaborative relationship between the high-income country (HIC) surgical educators of the Alliance for Global Clinical Training (Alliance) and the low-income country surgical educators at the Muhimbili University of Health and Allied Sciences/Muhimbili National Hospital (MUHAS/MNH), Dar Es Salaam, Tanzania, on the clinical global surgery training of the HIC surgical residents participating in the program. DESIGN: A retrospective qualitative analysis of Alliance volunteer HIC faculty and residents' reports, volunteer case lists and the reports of Alliance academic contributions to MUHAS/MNH from 2012 to 2017. In addition, a survey was circulated in late 2016 to all the residents who participated in the program since its inception. RESULTS: Twelve HIC surgical educators provided rotating 1-month teaching coverage at MUHAS/MNH between academic years 2012 and 2017 for a total of 21 months. During the same time period 11 HIC residents accompanied the HIC faculty for 1-month rotations. HIC surgery residents joined the MUHAS/MNH Department of Surgery, made significant teaching contributions, performed a wide spectrum of "open procedures" including hand-sewn intestinal anastomoses. Most had had either no or limited previous exposure to hand-sewn anastomoses. All of the residents commented that this was a maturing and challenging clinical rotation due to the complexity of the cases, the limited resources available and the ethical and emotional challenges of dealing with preventable complications and death in a resource constrained environment. CONCLUSIONS: The Alliance provides an effective clinical global surgery rotation at MUHAS/MNH for HIC Surgery Departments wishing to provide such an opportunity for their residents and faculty.


Subject(s)
Clinical Competence , Education, Medical, Graduate/organization & administration , General Surgery/education , Global Health , Health Care Coalitions/organization & administration , Adult , Cohort Studies , Developed Countries , Developing Countries , Female , Humans , Male , Organizational Innovation , Poverty , Program Evaluation , Retrospective Studies , Surveys and Questionnaires , Tanzania
5.
JAMA Surg ; 152(8): 784-791, 2017 Aug 01.
Article in English | MEDLINE | ID: mdl-28467526

ABSTRACT

IMPORTANCE: The human and financial costs of treating surgical site infections (SSIs) are increasing. The number of surgical procedures performed in the United States continues to rise, and surgical patients are initially seen with increasingly complex comorbidities. It is estimated that approximately half of SSIs are deemed preventable using evidence-based strategies. OBJECTIVE: To provide new and updated evidence-based recommendations for the prevention of SSI. EVIDENCE REVIEW: A targeted systematic review of the literature was conducted in MEDLINE, EMBASE, CINAHL, and the Cochrane Library from 1998 through April 2014. A modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach was used to assess the quality of evidence and the strength of the resulting recommendation and to provide explicit links between them. Of 5759 titles and abstracts screened, 896 underwent full-text review by 2 independent reviewers. After exclusions, 170 studies were extracted into evidence tables, appraised, and synthesized. FINDINGS: Before surgery, patients should shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day. Antimicrobial prophylaxis should be administered only when indicated based on published clinical practice guidelines and timed such that a bactericidal concentration of the agents is established in the serum and tissues when the incision is made. In cesarean section procedures, antimicrobial prophylaxis should be administered before skin incision. Skin preparation in the operating room should be performed using an alcohol-based agent unless contraindicated. For clean and clean-contaminated procedures, additional prophylactic antimicrobial agent doses should not be administered after the surgical incision is closed in the operating room, even in the presence of a drain. Topical antimicrobial agents should not be applied to the surgical incision. During surgery, glycemic control should be implemented using blood glucose target levels less than 200 mg/dL, and normothermia should be maintained in all patients. Increased fraction of inspired oxygen should be administered during surgery and after extubation in the immediate postoperative period for patients with normal pulmonary function undergoing general anesthesia with endotracheal intubation. Transfusion of blood products should not be withheld from surgical patients as a means to prevent SSI. CONCLUSIONS AND RELEVANCE: This guideline is intended to provide new and updated evidence-based recommendations for the prevention of SSI and should be incorporated into comprehensive surgical quality improvement programs to improve patient safety.


Subject(s)
Surgical Wound Infection/prevention & control , Adrenal Cortex Hormones/administration & dosage , Anti-Infective Agents, Local/therapeutic use , Antibiotic Prophylaxis/methods , Anticoagulants/therapeutic use , Arthroplasty, Replacement/methods , Biofilms , Blood Glucose/metabolism , Blood Transfusion/methods , Drainage/methods , Humans , Immunosuppressive Agents/therapeutic use , Injections, Intra-Articular , Oxygen/administration & dosage , Postoperative Care/methods , Protective Clothing
6.
7.
JAMA Surg ; 151(10): 954-958, 2016 10 01.
Article in English | MEDLINE | ID: mdl-27409973

ABSTRACT

Importance: Head injury following explosions is common. Rapid identification of patients with severe traumatic brain injury (TBI) in need of neurosurgical intervention is complicated in a situation where multiple casualties are admitted following an explosion. Objective: To evaluate whether Glasgow Coma Scale (GCS) score or the Simplified Motor Score at presentation would identify patients with severe TBI in need of neurosurgical intervention. Design, Setting, and Participants: Analysis of clinical data recorded in the Israel National Trauma Registry of 1081 patients treated following terrorist bombings in the civilian setting between 1998 and 2005. Primary analysis of the data was conducted in 2009, and analysis was completed in 2015. Main Outcomes and Measures: Proportion of patients with TBI in need of neurosurgical intervention per GCS score or Simplified Motor Score. Results: Of 1081 patients (median age, 29 years [range, 0-90 years]; 38.9% women), 198 (18.3%) were diagnosed as having TBI (48 mild and 150 severe). Severe TBI was diagnosed in 48 of 877 patients (5%) with a GCS score of 15 and in 99 of 171 patients (58%) with GCS scores of 3 to 14 (P < .001). In 65 patients with abnormal GCS (38%), no head injury was recorded. Nine of 877 patients (1%) with a GCS score of 15 were in need of a neurosurgical operation, and fewer than 51 of the 171 patients (30%) with GCS scores of 3 to 14 had a neurosurgical operation (P < .001). No difference was found between the proportion of patients in need of neurosurgery with GCS scores of 3 to 8 and those with GCS scores of 9 to 14 (30% vs 27%; P = .83). When the Simplified Motor Score and GCS were compared with respect to their ability to identify patients in need of neurosurgical interventions, no difference was found between the 2 scores. Conclusions and Relevance: Following an explosion in the civilian setting, 65 patients (38%) with GCS scores of 3 to 14 did not experience severe TBI. The proportion of patients with severe TBI and severe TBI in need of a neurosurgical intervention were similar in patients presenting with GCS scores of 3 to 8 and GCS scores of 9 to 14. In this study, GCS and Simplified Motor Score did not help identify patients with severe TBI in need of a neurosurgical intervention.


Subject(s)
Blast Injuries/diagnosis , Blast Injuries/surgery , Brain Injuries, Traumatic/diagnosis , Brain Injuries, Traumatic/surgery , Craniotomy/statistics & numerical data , Glasgow Coma Scale , Adolescent , Adult , Aged , Aged, 80 and over , Child , Child, Preschool , Explosions , Female , Humans , Infant , Infant, Newborn , Intracranial Pressure , Israel , Male , Middle Aged , Monitoring, Physiologic/statistics & numerical data , Needs Assessment , Terrorism , Young Adult
8.
JAMA Surg ; 150(11): 1074-8, 2015 Nov.
Article in English | MEDLINE | ID: mdl-26267612

ABSTRACT

IMPORTANCE: Surgical disease is a global health priority, and improving surgical care requires local capacity building. Single-institution partnerships and surgical missions are logistically limited. The Alliance for Global Clinical Training (hereafter the Alliance) is a consortium of US surgical departments that aims to provide continuous educational support at the Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania (MUHAS). To our knowledge, the Alliance is the first multi-institutional international surgical collaboration to be described in the literature. OBJECTIVE: To assess if the Alliance is effectively responding to the educational needs of MUHAS and Muhimbili National Hospital surgeons. DESIGN, SETTING, AND PARTICIPANTS: During an initial 13-month program (July 1, 2013, to August 31, 2014), faculty and resident teams from 3 US academic surgical programs rotated at MUHAS as physicians and teachers for 1 month each. To assess the value of the project, we administered anonymous surveys. MAIN OUTCOMES AND MEASURES: Anonymous surveys were analyzed on a 5-point Likert-type scale. Free-text answers were analyzed for common themes. RESULTS: During the study period, Alliance members were present at MUHAS for 8 months (1 month each). At the conclusion of the first year of collaboration, 15 MUHAS faculty and 22 MUHAS residents completed the survey. The following 6 areas of educational needs were identified: formal didactics, increased clinical mentorship, longer-term Alliance presence, equitable distribution of teaching time, improved coordination and language skills, and reciprocal exchange rotations at US hospitals. The MUHAS faculty and residents agreed that Alliance members contributed to improved patient care and resident education. CONCLUSIONS AND RELEVANCE: A multi-institutional international surgical partnership is possible and leads to perceived improvements in patient care and resident learning. Alliance surgeons must continue to focus on training Tanzanian surgeons. Improving the volunteer surgeons' Swahili-language skills would be an asset. Future efforts should provide more teaching coverage, equitably distribute educational support among all MUHAS surgeons, and collaboratively develop a formal surgical curriculum.


Subject(s)
Education, Medical/organization & administration , Medical Missions/organization & administration , Specialties, Surgical/education , Competency-Based Education , Developing Countries , Faculty, Medical/organization & administration , Female , General Surgery/education , Humans , Interinstitutional Relations , Internship and Residency/organization & administration , Male , Needs Assessment , Program Evaluation , Tanzania , United States
9.
10.
J Trauma Acute Care Surg ; 74(6): 1548-52, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23694886

ABSTRACT

BACKGROUND: "Found down" patients present to the emergency department (ED) after being discovered unconscious and are selected for trauma or medical evaluation based on ED triage. Occult injury is an important part of the differential diagnosis in these patients. Rational use of trauma resources and optimal care of these patients requires clear triage criteria and timely evaluation. METHODS: After an institutional review board approval was obtained, we retrospectively identified 201 "found down" patients from ED triage logs at an urban Level I trauma center between 2007 and 2011. Physician researchers reviewed these records for demographics, injuries, medical diagnoses, and mortality. RESULTS: Of the 201 "found down" patients, 86 (42.7%) had injuries on evaluation in the ED and 9 (4.5%) required urgent surgical intervention. Previous ED visits, homelessness, psychiatric diagnoses, and alcohol and substance use were strikingly common. The 41 patients (20.4%) triaged to admission by the trauma service were younger, predominantly male, and more likely to be intoxicated. Overall, 28 patients (13.4%) required consultation by the service to which they were not initially triaged. Nineteen (11.9%) of the medically triaged patients required trauma service consultation. Eight (19.5%) of the patients triaged to the trauma service required medical consultation, and 4 patients (9.8%) were ultimately admitted to a medicine service after a complete trauma evaluation. Six (14.6%) of the trauma patients and 3 (1.9%) of the medical patients had a delay in diagnosis of occult injuries. CONCLUSION: Nearly half of "found down" patients had clinically significant injuries, and late identified injuries were present in both trauma and medical patients. Twenty-eight (13.4%) of patients required consultation by the medical or trauma surgery service to which they were not initially triaged, highlighting pervasive triage discordance in this population. Early trauma surgery consultation and triage flexibility are critical to avoid missed injuries in "found down" patients. LEVEL OF EVIDENCE: Epidemiological study, level IV.


Subject(s)
Unconsciousness/diagnosis , Female , Humans , Male , Middle Aged , Retrospective Studies , Trauma Centers/statistics & numerical data , Triage/statistics & numerical data , Unconsciousness/etiology , Wounds and Injuries/complications , Wounds and Injuries/diagnosis
11.
Surgery ; 153(3): 326-7, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23375482
12.
J Trauma Acute Care Surg ; 73(3): 721-5, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22929501

ABSTRACT

BACKGROUND: Pediatric penetrating injuries plague inner cities. Based on our clinical observations, we hypothesized that pediatric penetrating trauma (PPT) is increasing with the major increase occurring in communities with lower socioeconomic status. METHODS: We retrospectively reviewed the trauma databases between 2000 and 2009 of the three major trauma centers in Alameda and San Francisco counties. Patients with PPT aged 16 years or younger were included. Demographics, Injury Severity Score, probability of survival, and length of hospital stay were collected. Median family incomes (MFI) were obtained from US Census data. RESULTS: We identified 598 patients with PPT: 432 gunshot wounds (GSWs), 141 stabbings, and 25 other. The rate of PPT increased by 138% from 2000 to 2009 (p = 0.003). The mean (SEM) age of the patients was 13.8 (0.1) years, which did not change during the study period (p = 0.12). The incidence of single GSW to the head increased from 3% to 7% (p = 0.01) and carried a 63% mortality rate. Blacks and Hispanics sustained 82.5% of PPT. The MFI of PPT victims was $39,209. PPT was more prevalent in zip codes with an MFI below the Bay Area MFI of $68,954, (mean [SEM], 8.0 [1.5] victims per zip code below MFI vs. 1.9 [0.3] victims per zip code above MFI; p = < 0.001). CONCLUSION: PPT in the Bay Area increased during the last decade, and the increased PPT was associated with lower MFIs. Black and Hispanic children experienced the greatest proportion of penetrating injuries and had the lowest MFIs. The prevalence of single GSW to the head is increasing, which may suggest a deliberate attempt to fatally injure these children. LEVELS OF EVIDENCE: Prognostic study, level II.


Subject(s)
Black or African American/statistics & numerical data , Cause of Death , Hispanic or Latino/statistics & numerical data , Multiple Trauma/epidemiology , Wounds, Penetrating/epidemiology , Adolescent , Age Distribution , Analysis of Variance , California/epidemiology , Child , Child, Preschool , Cohort Studies , Databases, Factual , Female , Hospital Mortality , Humans , Incidence , Injury Severity Score , Linear Models , Male , Multiple Trauma/diagnosis , Multiple Trauma/therapy , Multivariate Analysis , Poverty , Retrospective Studies , Risk Assessment , Sex Distribution , Socioeconomic Factors , Survival Analysis , Trauma Centers/statistics & numerical data , Wounds, Gunshot/diagnosis , Wounds, Gunshot/epidemiology , Wounds, Gunshot/therapy , Wounds, Penetrating/diagnosis , Wounds, Penetrating/therapy , Wounds, Stab/diagnosis , Wounds, Stab/epidemiology , Wounds, Stab/therapy
13.
Ann Vasc Surg ; 26(6): 819-24, 2012 Aug.
Article in English | MEDLINE | ID: mdl-22534261

ABSTRACT

BACKGROUND: Arterial injury and infection due to repetitive injection drug use can result in mycotic pseudoaneurysm predisposing to hemorrhage, distal embolism, limb loss, and death. We hypothesized that debridement of the infected artery, followed by immediate vascular reconstruction, results in successful limb salvage in these patients. METHODS: The setting was a county hospital. A retrospective review of all patients diagnosed with lower extremity pseudoaneurysms by the Departments of Surgery and Radiology between 2000 and 2009 was conducted. Outcome measures were patient characteristics, site(s) of lesion, type and results of imaging, type of operation, length of hospital stay, and complications. RESULTS: Sixteen patients had 17 pseudoaneurysms. One of the patients had two mycotic pseudoaneurysms in the same region separated by a period of 10 months. Culture of the wall of the first pseudoaneurysm was not performed. The second pseudoaneurysm was culture positive. The 15 remaining mycotic pseudoaneurysms were all culture positive. Nine patients were men, and the median age of the patient group was 37 years. Common femoral pseudoaneurysms were the most frequent (76%). Symptoms included swelling (94%), pain (82%), and erythema (75.6%). A rapidly expanding pulsatile expansile mass was present in four of the patients. Computed tomography and percutaneous angiography were done in seven and four of the patients, respectively, and were diagnostic in all cases studied. Resection and reconstruction with autologous vein was the most common procedure (seven), followed by cadaveric grafting (four), synthetic grafting (two), ligation (two), and primary repair (two). Muscle flaps were used in 76.5% of the cases. Complications included anastomotic dehiscence (n = 3), acute thrombosis (n = 1), ischemia (n = 1), abscess (n = 1), and compartment syndrome (n = 1). Three of these patients required a second vascular reconstruction. One patient ultimately required an amputation. No postoperative deaths occurred. Methicillin-resistant Staphylococcus aureus was cultured from 13 of the 16 arterial walls. CONCLUSION: Methicillin-resistant Staphylococcus aureus is the predominant organism causing mycotic aneurysms of the common and superficial femoral arteries owing to injection drug use at San Francisco General Hospital. Wide debridement of the infected artery and reconstruction with an in-line reversed saphenous vein or cryopreserved vascular allograft is a safe and effective method of treatment. Long-term follow-up studies are needed to determine the durability of this method of treatment.


Subject(s)
Aneurysm, False/surgery , Aneurysm, Infected/surgery , Debridement , Drug Users , Lower Extremity/blood supply , Staphylococcal Infections/surgery , Substance Abuse, Intravenous/complications , Vascular Surgical Procedures , Adult , Amputation, Surgical , Aneurysm, False/diagnosis , Aneurysm, False/microbiology , Aneurysm, Infected/diagnosis , Aneurysm, Infected/microbiology , Blood Vessel Prosthesis Implantation , Cross-Sectional Studies , Debridement/adverse effects , Female , Hospitals, County , Humans , Length of Stay , Ligation , Limb Salvage , Male , Methicillin-Resistant Staphylococcus aureus/isolation & purification , Middle Aged , Postoperative Complications/etiology , Reoperation , Retrospective Studies , San Francisco , Staphylococcal Infections/diagnosis , Staphylococcal Infections/microbiology , Surgical Flaps , Time Factors , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Veins/transplantation , Young Adult
14.
World J Surg ; 36(5): 966-72, 2012 May.
Article in English | MEDLINE | ID: mdl-22411082

ABSTRACT

Blast injuries have been increasing in the civilian setting and clinicians need to understand the spectrum of injury and management strategies. Multisystem trauma associated with combined blunt and penetrating injuries is the rule. Explosions in closed spaces increase the likelihood of primary blast injury. Rupture of tympanic membranes is an inaccurate marker for severe primary blast injury. Blast lung injury manifests early and should be managed with lung-protective ventilation. Blast brain injury is more common than previously appreciated.


Subject(s)
Blast Injuries , Multiple Trauma , Blast Injuries/classification , Blast Injuries/diagnosis , Blast Injuries/etiology , Blast Injuries/therapy , Explosions , Humans , Multiple Trauma/classification , Multiple Trauma/diagnosis , Multiple Trauma/etiology , Multiple Trauma/therapy , Terrorism , Trauma Severity Indices
16.
Surg Clin North Am ; 91(3): 481-91, 2011 Jun.
Article in English | MEDLINE | ID: mdl-21621692

ABSTRACT

Management of enterocutaneous fistulas (ECFs) involves (1) recognition and stabilization, (2) anatomic definition and decision, and (3) definitive operation. Phase 1 encompasses correction of fluid and electrolyte imbalance, skin protection, and nutritional support. Abdominal imaging defines the anatomy of the fistula in phase 2. ECFs that do not heal spontaneously require segmental resection of the bowel segment communicating with the fistula and restoration of intestinal continuity in phase 3. The enteroatmospheric fistula (EAF) is a malevolent condition requiring prolonged wound care and nutritional support. Complex abdominal wall reconstruction immediately following fistula resection is necessary for all EAFs.


Subject(s)
Cutaneous Fistula/therapy , Intestinal Fistula/therapy , Postoperative Complications/therapy , Cutaneous Fistula/classification , Enteral Nutrition , Hormones/therapeutic use , Humans , Intestinal Fistula/classification , Octreotide/therapeutic use , Somatostatin/therapeutic use , Wound Healing/physiology
20.
Arch Surg ; 145(1): 28-33, 2010 Jan.
Article in English | MEDLINE | ID: mdl-20083751

ABSTRACT

OBJECTIVE: To compare outcome parameters for good-risk patients with classic signs, symptoms, and laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE) or endoscopic retrograde cholangiopancreatography sphincterotomy plus laparoscopic cholecystectomy (ERCP/S+LC). DESIGN: Our study was a prospective trial conducted following written informed consent, with randomization by the serially numbered, opaque envelope technique. SETTING: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco, California. PATIENTS: We randomized 122 patients (American Society of Anesthesiologists grade 1 or 2) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before 1 or both procedures were completed. INTERVENTIONS: Treatment was preoperative ERCP/S followed by LC, or LC+LCBDE. MAIN OUTCOME MEASURES: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary end points were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores. RESULTS: The baseline characteristics of the 2 randomized groups were similar. Efficacy of stone clearance was likewise equivalent for both groups. The time from first procedure to discharge was significantly shorter for LC+LCBDE (mean [SD], 55 [45] hours vs 98 [83] hours; P < .001). Hospital service and total charges for index hospitalization were likewise lower for LC+LCBDE, but the differences were not statistically significant. The professional fee charges for LC+LCBDE were significantly lower than those for ERCP/S+LC (median [SD], $4820 [1637] vs $6139 [1583]; P < .001). Patient acceptance and quality of life scores were equivalent for both groups. CONCLUSIONS: Both ERCP/S+LC and LC+LCBDE were highly effective in detecting and removing common bile duct stones and were equivalent in overall cost and patient acceptance. However, the overall duration of hospitalization was shorter and physician fees lower for LC+LCBDE. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00807729.


Subject(s)
Cholecystolithiasis/surgery , Choledocholithiasis/surgery , Common Bile Duct/surgery , Gallstones/surgery , Adult , Biliary Tract Surgical Procedures/methods , Cholangiopancreatography, Endoscopic Retrograde , Cholecystectomy, Laparoscopic , Female , Gallstones/therapy , Humans , Male , Middle Aged , Prospective Studies , Sphincterotomy, Endoscopic
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