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1. Tension-Free Inguinal Hernia Repair: The Design of a Trial to Compare Open and Laparoscopic Surgical Techniques

Author

Martin J. London, James Gibbs, Leigh Neumayer, Dorothy D. Dunlop, Stephanie Hatton-Ward, Olga Jonasson, Kamal M.F. Itani, Lawrence T. Kim, Theodore N. Pappas, Anita Giobbie-Hurder, Denise M. Hynes, Domenic J. Reda, Martin McCarthy, Robert J. Fitzgibbons, C. James Carrico, and William G. Henderson

Subjects
Male, Laparoscopic surgery, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Hernia, Inguinal, law.invention, Postoperative Complications, Randomized controlled trial, Recurrence, law, Multicenter trial, medicine, Humans, Hernia, Laparoscopy, medicine.diagnostic_test, business.industry, Health Services, Middle Aged, medicine.disease, Hernia repair, Health Surveys, United States, Surgery, Clinical trial, Inguinal hernia, Treatment Outcome, Research Design, Costs and Cost Analysis, business, Follow-Up Studies
Abstract

Background Inguinal hernia is a common condition in men and represents a large component of health-care expenditures. Approximately 700,000 herniorrhaphies are performed each year in the United States. The most effective method of repair of an inguinal hernia is not known. Study design A multicenter, randomized, clinical trial was designed to compare open tension-free inguinal hernia repair with laparoscopic tension-free repair on recurrence rates, complications, patient-centered outcomes, and cost. The study design called for randomization of 2,200 men over a period of 3 years. These men will be followed for a minimum of 2 years. This will allow determination of as little as a 3% absolute difference in recurrence rates with 80% power. Randomization is stratified by hospital, whether the hernia is unilateral or bilateral and whether the hernia is primary or recurrent. Results This is a report of the study design and current status. The study involves 14 Veterans Affairs medical centers with previous experience in laparoscopic hernia repair. After 35 months of enrollment, 2,165 men were randomized and recruitment was then closed. The majority of the patients (82.3%) had unilateral hernias and 90.6% of the hernias were primary. Sixty-seven percent of the patients had an outpatient operation. Conclusions We report successful recruitment into a large multicenter trial comparing open and laparoscopic hernia repair. When followup is complete, this study will provide data regarding both clinical (recurrence rates) and patient-centered outcomes.

Published
2003
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2. Long-term Cost-effectiveness in the Veterans Affairs Open vs Endovascular Repair Study of Aortic Abdominal Aneurysm

Author

Hosam Farouk El Sayed, Cinda Sobotta, Reba Jones, Kellie R. Brown, Henry M. Baraniewski, Amanda J. Snodgrass, C. Keith Ozaki, Fred N. Littooy, Roderick A. Barke, Christian De Virgillio, Richard J. Massen, Anne S. Irwin, Gregory L. Moneta, George Pisimisis, Sister Frances Randall, Sheila M. Coogan, Joseph S. Giglia, Caron Rockman, Richard L. McCann, David Whitley, Erika R. Ketteler, Jeffrey H. Lawson, Matthew W. Mell, John L. Gray, Angela G. Vouyouka, Howard Greisler, Roy M. Fujitani, John W. Hallett, James M. Goff, Kathleen Hickson, Elizabeth Latts, Claudia Yales, Margaret Antonelli, Mina Behdad, Andrea M. Escalante, Karen Chong, Stephen M. Kubaska, Jorge Lopez, Joseph J. Cullen, Glenn C. Hunter, Brenda J. Jasper, John M. Marek, Kimberly Yan, Dennis F. Bandyk, June Poulton, Thomas S. Burdick, Bassem Safadi, Richard J. Gusberg, Sally Reinhardt, Erik Owens, Randy Baum, Robert J. Guerra, Laura Ashe, Mary T. O'Sullivan, Edward Perry, Michael A. Golden, Lynn Durant, Peter H. Lin, Margaret L. Schwarze, Jennifer Poirier, Jessie M. Jean-Claude, Jane Guidot, J. David Pitcher, Elaine O'Brien, Steven J. Busuttil, Stephanie Ross, Darra D. Kingsley, Vicki Bishop, Anna Busman, Kathleen M. Swanson, Rebecca L. Reinhard, Scott Zellner, Beth A. Forbes, John L. Mills, Carmelene Joncas, Georgia Purviance, Theodore Karrison, Sherilyn Pillack, Christine Maagas, Mark Langsfeld, Nancy Oberle, Stephen G. Lalka, Clair M. Haakenson, Carlos F. Bechara, Scott A. Berceli, Murray L. Shames, Michelle A. Bhola, Mary Le Gwin, Anna Rockich, Stephen P. Johnson, Robert W. Zickler, Julie A. Freischlag, John P. Matts, Heather G. Allore, Christian Bianchi, Bernadette Aulivola, Terry O'Connor, Richard A. Yeager, Brad Johnson, Ronald M. Fairman, John F. Eidt, Melita Braganza, Alice Kossack, Rajni Mehta, Bauer E. Sumpio, David Minion, Joseph H. Rapp, Brajesh K. Lal, Michelle Endo, Jon S. Matsumura, Iraklis I. Pipinos, Melanie Estes, Girma Tefera, Mitzi Rusomaroff, Gregory J. Landry, John R. Hoch, Cindy Inman, Janice Rieder, Loretta Cole, Gary Lemmon, Shemuel B. Psalms, James M. Edwards, Ted R. Kohler, Peter R. Nelson, David A. Katz, Hugh A. Gelabert, James Ebaugh, Brian D. Lewis, Nancy N. Day, Nikhil Kansal, Glenn R. Jacobowitz, Ruth L. Bush, Reverend Michael Zeman, Sandra M. Walsh, Jill Warner-Carpenter, Catherine Cagiannos, Mark R. Nehler, Carlos H. Timaran, Prakash Chand, Leah J. Caropolo, Ling Ge, Shirley Joyner, Karen Eschberger, Mohammed Moursi, Michael P. Lilly, Susan Framberg, Christa Kallio, Robyn A. Macsata, Barbara Salabsky, Charles W. Acher, Frank A. Lederle, Jason M. Johanning, Tammy Nguyen, Gerald Treiman, Ian L. Gordon, Deanna Maples, Catherine Proebstle, Joy Kimbrough, William Farrell, Satish Muluk, Gilles Pinault, Beth Dunlap, Sandra C. Carr, William D. Jordan, Erin Olgren, Thomas A. Whitehill, Donald Beckwith, Peter Guarino, Lloyd M. Taylor, Wendy Meadows, Vanessa McBride, Subodh Arora, James Niederman, E. Lynne Kelly, Jonathan Weiswasser, David G. Glickerman, Gene Guinn, Pamela Strecker, Bart E. Muhs, Eleanor Cannady, Heron E. Rodriguez, Christopher Owens, Karen L. Wilson, Shawna Thunen, Elizabeth Davis, Stanislav V. Kasl, Shelley S. Dwyer, Julie Thornton, Maria Foster, Vickie Beach, Doghdoo D. Bahmani, Penny Vasilas, Luis R. Leon, Matthew Nalbandian, Reza Azadegan, Diane C. Robertson, Richard A. Marottoli, Ross Milner, John M. Stuart, David A. Rigberg, Nina M. Peterson, Mary Evans, David Chew, Subhash Lathi, Nadine White, Macario Riveros, Jeffrey Pollak, Timothy J. O'Leary, Yvonne Jonk, Frank T. Padberg, Richard Feldman, Stephanie Hatton-Ward, J. Gregory Modrall, Paul J. Gagne, James Wong, Kimberly Pedersen, Norman Hertzer, Brian D. Matteson, Wei Zhou, Nina Lee, Mark W. Sebastian, Steven M. Santilli, William C. Krupski, Neal Cayne, Anton N. Sidawy, Neal R. Barshes, Christina Paap, Sherry M. Wren, Alex Westerband, Sandra Brock, Vivian Gahtan, John D. Hughes, Panagiotis Kougias, Jonathan B. Towne, Michael Ranella, W. Anthony Lee, Ryan Nachreiner, Cynthia K. Shortell, Patricia A. Prinzo, Kea Ellis, Ronald L. Dalman, Thomas G. Lynch, Karthikeshwar Kasirajan, H. Edward Garrett, Joaquim J. Cerveira, Peter Peduzzi, Marcelo Spector, Carla Blackwell, Omran Abul-Khoudoud, Dolores F. Cikrit, Jean Kistler Tetterton, Martin Back, Darrell N. Jones, Darryl S. Weiman, Donna Kerns, Mark Wilson, Preet Kang, Kenneth Granke, Gary R. Johnson, Linda M. Reilly, Marilyn Bader, Lauri Lee Johnson, Ravi K. Veeraswamy, Sandra L. Perez, W. John Sharp, Gary R. Seabrook, Karthnik Kasirajan, Brenda Allende, John D. Corson, Kathy Zalecki, Joseph D. Raffetto, Thomas H. Schwarcz, Mark A. Patterson, Matthew Eiseman, John K.Y. Chacko, Mark Adelman, Holly De Spiegelaere, Alan Dardik, Madeline Ruf, Kevin T. Stroupe, Grant D. Huang, M. Burress Welborn, Alexandre C. D'Audiffret, Rajaabrata Sarkar, Michael Sobel, Steve M. Taylor, Barbara Guillory, Sandra C. Thomas, Thomas S. Hatsukami, Robert A. Cambria, Jeanne L. McCandless, Susan Stratton, Cindy Cushing, Karen A. Hauck, Atef Salam, Melina R. Kibbe, Tassos C. Kyriakides, Amy B. Reed, Jason T. Lee, Jamal J. Hoballah, Marc E. Mitchell, Hasan H. Dosluoglu, Marc A. Passman, Edith Tzeng, Patricia Cleary, and John Aruny

Subjects
Diagnostic Imaging, Male, medicine.medical_specialty, Time Factors, Cost effectiveness, Cost-Benefit Analysis, Comparative effectiveness research, 030204 cardiovascular system & hematology, 030230 surgery, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Humans, Medicine, cardiovascular diseases, Veterans Affairs, health care economics and organizations, Aged, Intention-to-treat analysis, business.industry, Endovascular Procedures, Health Care Costs, Length of Stay, Middle Aged, medicine.disease, Abdominal aortic aneurysm, Quality-adjusted life year, Surgery, Elective Surgical Procedures, Quality of Life, Health Resources, Female, Quality-Adjusted Life Years, business, Aortic Aneurysm, Abdominal, Follow-Up Studies, Abdominal surgery
Abstract

Importance Because of the similarity in clinical outcomes after elective open and endovascular repair of abdominal aortic aneurysm (AAA), cost may be an important factor in choosing a procedure. Objective To compare total and AAA-related use of health care services, costs, and cost-effectiveness between groups randomized to open or endovascular repair. Design, Setting, and Participants This unblinded randomized clinical trial enrolled 881 patients undergoing planned elective repair of AAA who were candidates for open and endovascular repair procedures. Patients were randomized from October 15, 2002, to April 15, 2008, at 42 Veterans Affairs medical centers. Follow-up was completed on October 15, 2011, and data were analyzed from April 15, 2013, to April 15, 2016, based on intention to treat. Main Outcomes and Measures Mean total and AAA-related health care cost per life-year and per quality-adjusted life-year (QALY). Results A total of 881 patients (876 men [99.4%]; 5 women [0.6%]; mean [SD] age, 70 [7.8] years) were included in the analysis. After a mean of 5.2 years of follow-up, mean life-years were 4.89 in the endovascular group and 4.84 in the open repair group ( P = .68), and mean QALYs were 3.72 in the endovascular group and 3.70 in the open repair group ( P = .82). Total mean health care costs did not differ significantly between the 2 groups (endovascular group, $142 745; open repair group, $153 533; difference, −$10 788; 95% CI, −$29 796 to $5825; P = .25). Costs related to AAA, including the initial repair, constituted nearly 40% of total costs and did not differ significantly between the 2 groups (endovascular group, $57 501; open repair group, $57 893; difference, −$393; 95% CI, −$12 071 to $7928; P = .94). Lower costs due to shorter hospitalization for initial endovascular repair were offset by increased costs from AAA-related secondary procedures and imaging studies. The probability of endovascular repair being less costly and more effective was 56.8% when effectiveness was measured in life-years and 55.4% when effectiveness was measured in QALYs for total costs and 31.3% and 34.3%, respectively, for AAA-related costs. Conclusions and Relevance In this multicenter randomized clinical trial with follow-up to 9 years, survival, quality of life, costs, and cost-effectiveness did not differ between elective open and endovascular repair of AAA. Trial Registration clinicaltrials.gov Identifier:NCT00094575

Published
2016
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3. Costs of repair of abdominal aortic aneurysm with different devices in a multicenter randomized trial

Author

Jon S. Matsumura, Kevin T. Stroupe, Frank A. Lederle, Tassos C. Kyriakides, Ling Ge, Julie A. Freischlag, Erika R. Ketteler, Darra D. Kingsley, John M. Marek, Richard J. Massen, Brian D. Matteson, J. David Pitcher, Mark Langsfeld, John D. Corson, James M. Goff, Karthnik Kasirajan, Christina Paap, Diane C. Robertson, Atef Salam, Ravi Veeraswamy, Ross Milner, Karthikeshwar Kasirajan, Jane Guidot, Brajesh K. Lal, Steven J. Busuttil, Michael P. Lilly, Melita Braganza, Kea Ellis, Mark A. Patterson, William D. Jordan, David Whitley, Steve Taylor, Marc Passman, Donna Kerns, Cindy Inman, Jennifer Poirier, James Ebaugh, Joseph Raffetto, David Chew, Subhash Lathi, Christopher Owens, Kathleen Hickson, Hasan H. Dosluoglu, Karen Eschberger, Melina R. Kibbe, Henry M. Baraniewski, Jon Matsumura, Michelle Endo, Anna Busman, Wendy Meadows, Mary Evans, Joseph S. Giglia, Hosam El Sayed, Amy B. Reed, Madeline Ruf, Stephanie Ross, Jessie M. Jean-Claude, Gilles Pinault, Preet Kang, Nadine White, Matthew Eiseman, Reba Jones, Carlos H. Timaran, J. Gregory Modrall, M. Burress Welborn, Jorge Lopez, Tammy Nguyen, John K.Y. Chacko, Kenneth Granke, Angela G. Vouyouka, Erin Olgren, Prakash Chand, Brenda Allende, Michael Ranella, Claudia Yales, Thomas A. Whitehill, William C. Krupski, Mark R. Nehler, Stephen P. Johnson, Darrell N. Jones, Pamela Strecker, Michelle A. Bhola, Cynthia K. Shortell, John L. Gray, Jeffrey H. Lawson, Richard McCann, Mark W. Sebastian, Jean Kistler Tetterton, Carla Blackwell, Patricia A. Prinzo, Nina Lee, Frank T. Padberg, Joaquim J. Cerveira, Robert W. Zickler, Karen A. Hauck, Scott A. Berceli, W. Anthony Lee, C. Keith Ozaki, Peter R. Nelson, Anne S. Irwin, Randy Baum, Bernadette Aulivola, Heron Rodriguez, Fred N. Littooy, Howard Greisler, Mary T. O'Sullivan, Panagiotis Kougias, Peter H. Lin, Ruth L. Bush, Gene Guinn, Catherine Cagiannos, Sherilyn Pillack, Barbara Guillory, Dolores Cikrit, Stephen G. Lalka, Gary Lemmon, Ryan Nachreiner, Mitzi Rusomaroff, Elaine O'Brien, Joseph J. Cullen, Jamal Hoballah, W. John Sharp, Jeanne L. McCandless, Vickie Beach, David Minion, Thomas H. Schwarcz, Joy Kimbrough, Laura Ashe, Anna Rockich, Jill Warner-Carpenter, Mohammed Moursi, John F. Eidt, Sandra Brock, Christian Bianchi, Vicki Bishop, Ian L. Gordon, Roy Fujitani, Stephen M. Kubaska, Mina Behdad, Reza Azadegan, Christine Ma Agas, Kathy Zalecki, John R. Hoch, Sandra C. Carr, Charles Acher, Margaret Schwarze, Girma Tefera, Matthew Mell, Beth Dunlap, Janice Rieder, John M. Stuart, Darryl S. Weiman, Omran Abul-Khoudoud, H. Edward Garrett, Sandra M. Walsh, Karen L. Wilson, Gary R. Seabrook, Robert A. Cambria, Kellie R. Brown, Brian D. Lewis, Susan Framberg, Christa Kallio, Roderick A. Barke, Steven M. Santilli, Alexandre C. d'Audiffret, Nancy Oberle, Catherine Proebstle, Lauri Lee Johnson, Glenn R. Jacobowitz, Neal Cayne, Caron Rockman, Mark Adelman, Paul Gagne, Matthew Nalbandian, Leah J. Caropolo, Iraklis I. Pipinos, Jason Johanning, Thomas Lynch, Holly DeSpiegelaere, Georgia Purviance, Wei Zhou, Ronald Dalman, Jason T. Lee, Bassem Safadi, Sheila M. Coogan, Sherry M. Wren, Doghdoo D. Bahmani, Deanna Maples, Shawna Thunen, Michael A. Golden, Marc E. Mitchell, Ronald Fairman, Sally Reinhardt, Mark A. Wilson, Edith Tzeng, Satish Muluk, Nina M. Peterson, Maria Foster, James Edwards, Gregory L. Moneta, Gregory Landry, Lloyd Taylor, Richard Yeager, Eleanor Cannady, Gerald Treiman, Stephanie Hatton-Ward, Barbara Salabsky, Nikhil Kansal, Erik Owens, Melanie Estes, Beth A. Forbes, Cinda Sobotta, Joseph H. Rapp, Linda M. Reilly, Sandra L. Perez, Kimberly Yan, Rajaabrata Sarkar, Shelley S. Dwyer, Ted R. Kohler, Thomas S. Hatsukami, David G. Glickerman, Michael Sobel, Thomas S. Burdick, Kimberly Pedersen, Patricia Cleary, Martin Back, Dennis Bandyk, Brad Johnson, Murray Shames, Rebecca L. Reinhard, Sandra C. Thomas, Glenn C. Hunter, Luis R. Leon, Alex Westerband, Robert J. Guerra, Macario Riveros, John L. Mills, John D. Hughes, Andrea M. Escalante, Shemuel B. Psalms, Nancy N. Day, Robyn Macsata, Anton Sidawy, Jonathan Weiswasser, Subodh Arora, Brenda J. Jasper, Alan Dardik, Vivian Gahtan, Bart E. Muhs, Bauer E. Sumpio, Richard J. Gusberg, Marcelo Spector, Jeffrey Pollak, John Aruny, E. Lynne Kelly, James Wong, Penny Vasilas, Carmelene Joncas, Hugh A. Gelabert, Christian DeVirgillio, David A. Rigberg, and Loretta Cole

Subjects
medicine.medical_specialty, Time Factors, medicine.medical_treatment, Prosthesis Design, Endovascular aneurysm repair, law.invention, Blood Vessel Prosthesis Implantation, Aortic aneurysm, Randomized controlled trial, law, Blood vessel prosthesis, Health care, medicine, Humans, Hospital Costs, Veterans Affairs, health care economics and organizations, Health economics, business.industry, Endovascular Procedures, Health Care Costs, Length of Stay, medicine.disease, United States, Abdominal aortic aneurysm, Blood Vessel Prosthesis, Surgery, United States Department of Veterans Affairs, Treatment Outcome, Stents, Health Expenditures, Cardiology and Cardiovascular Medicine, business, Aortic Aneurysm, Abdominal
Abstract

Objective Prior analysis in the Open vs Endovascular Repair Veterans Affairs (VA) Cooperative Study (CSP #498) demonstrated that survival, quality of life, and total health care costs are not significantly different between the open and endovascular methods of repair of abdominal aortic aneurysm. The device is a major cost of this method of repair, and the objective of this study was to evaluate the costs of the device, abdominal aortic aneurysm repair, and total health care costs when different endograft systems are selected for the endovascular repair (EVR). Within each selected system, EVR costs are compared with open repair costs. Methods The study randomized 881 patients to open (n = 437) or EVR (n = 444). Device selection was recorded before randomization; therefore, open repair controls were matched to each device cohort. Data were excluded for two low-volume devices, implanted in only 13 individuals, leaving 423 control and 431 endovascular patients: 166 Zenith (Cook Medical, Bloomington, Ind), 177 Excluder (W. L. Gore & Associates, Flagstaff, Ariz), and 88 AneuRx (Medtronic, Minneapolis, Minn). Mean device, hospitalization, and total health care costs from randomization to 2 years were compared. Health care utilization data were obtained from patients and national VA and Medicare data sources. VA costs were determined using methods previously developed by the VA Health Economics Resource Center. Non-VA costs were obtained from Medicare claims data and billing data from the patient's health care providers. Results Implant costs were 38% of initial hospitalization costs. Mean device (range, $13,600-$14,400), initial hospitalization (range, $34,800-$38,900), and total health care costs at 2 years in the endovascular (range, $72,400-$78,200) and open repair groups (range, $75,600-$82,100) were not significantly different among device systems. Differences between endovascular and corresponding open repair cohorts showed lower mean costs for EVR (range, $3200-$8300), but these were not statistically different. Conclusions The implant costs of endovascular aneurysm repair are substantial. When evaluating total health care system expenditures, there is large individual variability in costs, and there is no significant difference at 2 years among systems or when an individual system is compared with open repair.

Published
2015
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