Karla Bernardi1,2, Oscar A Olavarria1,2, Julie L Holihan1,2, Lillian S Kao1,2, Tien C Ko1, John S Roth3, Shawn Tsuda4, Khashayar Vaziri5, Mike K Liang1,2. 1. Department of Surgery, McGovern Medical School at the University of Texas Health Science Center Houston, Houston, TX. 2. Center for Surgical Trials and Evidence-Based Practice, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, TX. 3. Department of Surgery, University of Kentucky, Lexington, KY. 4. Department of Surgery, University of Nevada Las Vegas Medicine, Las Vegas, NV. 5. Department of Surgery, George Washington University, Washington, DC.
Abstract
BACKGROUND: Observational studies have reported conflicting results with primary fascial closure (PFC) versus bridged repair during laparoscopic ventral hernia repair (LVHR). OBJECTIVE: The aim of the study was to determine whether when evaluated in a randomized controlled trial (RCT), PFC compared to bridged repair would improve patient quality of life (QoL). METHODS: In this blinded, multicenter RCT, patients scheduled for elective LVHR (hernia defects 3 to 10 cm on computed tomography scan) were randomized to PFC versus bridged repair. Primary outcome was change in QoL after LVHR using a validated, hernia-specific survey (1 = poor QoL and 100 = perfect QoL) that measures pain, function, cosmesis, and satisfaction. Secondary outcomes were postoperative surgical site occurrences (including hematoma, seroma, surgical site infection, and wound dehiscence), abdominal eventration, and hernia recurrence. The trial was powered to detect a difference in change in QoL of 7 points between the study groups. Outcomes were compared with Mann-Whitney U test or chi-square. RESULTS: A total of 129 patients underwent LVHR and 107 (83%) completed follow-up at 2 years. Patients from both groups were similar at baseline. On median follow-up of 24 months (range: 9-42), patients treated with LVHR-PFC had on average a 12-point higher improvement in QoL compared to bridged repair (improvement in QoL, 41.3 ± 31.5 vs 29.7 ± 28.7, P value = 0.047). There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups. CONCLUSIONS: Among patients undergoing elective LVHR, the fascial defect should be closed. This is the first RCT demonstrating that PFC with LVHR significantly improves patient QoL. TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov (NCT02363790).
RCT Entities:
BACKGROUND: Observational studies have reported conflicting results with primary fascial closure (PFC) versus bridged repair during laparoscopic ventral hernia repair (LVHR). OBJECTIVE: The aim of the study was to determine whether when evaluated in a randomized controlled trial (RCT), PFC compared to bridged repair would improve patient quality of life (QoL). METHODS: In this blinded, multicenter RCT, patients scheduled for elective LVHR (hernia defects 3 to 10 cm on computed tomography scan) were randomized to PFC versus bridged repair. Primary outcome was change in QoL after LVHR using a validated, hernia-specific survey (1 = poor QoL and 100 = perfect QoL) that measures pain, function, cosmesis, and satisfaction. Secondary outcomes were postoperative surgical site occurrences (including hematoma, seroma, surgical site infection, and wound dehiscence), abdominal eventration, and hernia recurrence. The trial was powered to detect a difference in change in QoL of 7 points between the study groups. Outcomes were compared with Mann-Whitney U test or chi-square. RESULTS: A total of 129 patients underwent LVHR and 107 (83%) completed follow-up at 2 years. Patients from both groups were similar at baseline. On median follow-up of 24 months (range: 9-42), patients treated with LVHR-PFC had on average a 12-point higher improvement in QoL compared to bridged repair (improvement in QoL, 41.3 ± 31.5 vs 29.7 ± 28.7, P value = 0.047). There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups. CONCLUSIONS: Among patients undergoing elective LVHR, the fascial defect should be closed. This is the first RCT demonstrating that PFC with LVHR significantly improves patient QoL. TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov (NCT02363790).
Authors: F Köckerling; D Adolf; K Zarras; R Fortelny; R Lorenz; B Lammers; W Reinpold; B Stechemesser; C Schug-Pass; D Weyhe Journal: Hernia Date: 2021-04-10 Impact factor: 4.739
Authors: Alba Manuel-Vázquez; Anita Balakrishnan; Paul Agami; Bodil Andersson; Frederik Berrevoet; Marc G Besselink; Ugo Boggi; Damiano Caputo; Alberto Carabias; Lucia Carrion-Alvarez; Carmen Cepeda Franco; Alessandro Coppola; Bobby V M Dasari; Sherley Diaz-Mercedes; Michail Feretis; Constantino Fondevila; Giuseppe Kito Fusai; Giuseppe Garcea; Victor Gonzabay; Miguel Ángel Gómez Bravo; Myrte Gorris; Bart Hendrikx; Camila Hidalgo-Salinas; Prashant Kadam; Dimitrios Karavias; Emanuele Kauffmann; Amar Kourdouli; Vincenzo La Vaccara; Stijn van Laarhoven; James Leighton; Mike S L Liem; Nikolaos Machairas; Dimitris Magouliotis; Adel Mahmoud; Marco V Marino; Marco Massani; Paola Melgar Requena; Keno Mentor; Niccolò Napoli; Jorieke H T Nijhuis; Andrej Nikov; Cristina Nistri; Victor Nunes; Eduardo Ortiz Ruiz; Sanjay Pandanaboyana; Baltasar Pérez Saborido; Radek Pohnán; Mariuca Popa; Belinda Sánchez Pérez; Francisco Sánchez Bueno; Alejandro Serrablo; Mario Serradilla-Martín; James R A Skipworth; Kjetil Soreide; Dimitris Symeonidis; Dimitris Zacharoulis; Piotr Zelga; Daniel Aliseda; María Jesús Castro Santiago; Carlos Fernández Mancilla; Raquel Latorre Fragua; Daniel Llwyd Hughes; Carmen Payá Llorente; Mickaël Lesurtel; Tom Gallagher; José Manuel Ramia Journal: Langenbecks Arch Surg Date: 2022-10-06 Impact factor: 2.895
Authors: Oscar A Olavarria; Karla Bernardi; Naila H Dhanani; Nicole B Lyons; John A Harvin; Stefanos G Millas; Tien C Ko; Lillian S Kao; Mike K Liang Journal: Surg Infect (Larchmt) Date: 2020-12-01 Impact factor: 1.853
Authors: Oscar A Olavarria; Karla Bernardi; Shinil K Shah; Todd D Wilson; Shuyan Wei; Claudia Pedroza; Elenir B Avritscher; Michele M Loor; Tien C Ko; Lillian S Kao; Mike K Liang Journal: BMJ Date: 2020-07-14
Authors: William W Hope; Adel G El-Ghazzawy; Brad A Winterstein; Jeffrey A Blatnik; S Scott Davis; Jacob A Greenberg; Noel C Sanchez; Eric M Pauli; Daniel M Tseng; Karl A LeBlanc; Kurt E Roberts; Curtis E Bower; Eduardo Parra-Davila; J Scott Roth; Corey R Deeken; Eric F Smith Journal: Ann Med Surg (Lond) Date: 2021-12-06