TY - JOUR
T1 - Prospective, multicenter, pairwise analysis of robotic-assisted inguinal hernia repair with open and laparoscopic inguinal hernia repair
T2 - early results from the Prospective Hernia Study
AU - The Prospective Hernia Study Group
AU - LeBlanc, K.
AU - Dickens, E.
AU - Gonzalez, A.
AU - Gamagami, R.
AU - Pierce, R.
AU - Balentine, C.
AU - Voeller, G.
N1 - Funding Information:
This study was sponsored and funded by Intuitive Surgical Inc., Sunnyvale, CA, USA, in association with the study chair under a cooperative clinical trial agreement.
Funding Information:
Drs. Balentine, Dickens, Gamagami, Gonzalez, LeBlanc, Pierce, and Voeller received clinical research grants from Intuitive Surgical. Drs. Dickens and LeBlanc receive personal fees for consulting and education from Intuitive. Dr. Gamagami receives personal fees for consulting and proctoring from Intuitive. Dr. Gonzalez receives personal fees for teaching and proctoring from Intuitive. Dr. LeBlanc receives personal fees from Intuitive, personal fees from W.L. Gore & Associates, Inc., personal fees from Davol Inc., non-financial support from Covidien LP, and personal fees from RTI Surgical, Inc, outside the submitted work; The authors have no other conflicts of interest to disclose.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Purpose: To evaluate and compare peri-operative outcomes through 30 days, including pain and quality of life (QOL) through 3 months across three cohorts of inguinal hernia repair (IHR) patients (robotic-assisted, laparoscopic, and open IHR). Methods: The Prospective Hernia Study is an ongoing, multicenter, comparative, open-label analysis of clinical and patient-reported outcomes from robotic-assisted surgery (RAS) versus open and RAS versus laparoscopic IHR procedures. Patient responses to the Carolinas Comfort Scale (CCS) questionnaire provided QOL outcomes. Results: 504 enrolled patients underwent unilateral or bilateral IHR (RAS, n = 159; open, n = 190; laparoscopic, n = 155) at 17 medical institutions from May 2016 through December 2018. Propensity score matching provided a balanced comparison: RAS versus open (n = 112 each) and RAS versus laparoscopic (n = 80 each). Overall, operative times were significantly different between the RAS and laparoscopic cases (83 vs. 65 min; p < 0.001). Fewer RAS patients required prescription pain medication than either open (49.5% vs. 80.0%; p < 0.001) or laparoscopic patients (45.3% vs. 65.4%; p = 0.013). Median number of prescription pain pills taken differed for RAS vs. open (0.5 vs. 15.5; p = 0.001) and were comparable for RAS vs laparoscopic (7.0 vs. 6.0; p = 0.482) among patients taking prescribed pain medication. Time to return to normal activities differed for RAS vs. open (3 vs. 4 days; p = 0.005) and were comparable for RAS vs. laparoscopic (4 vs. 4 days; p = 0.657). Median CCS scores through 3 months were comparable for the three approaches. Postoperative complication rates for the three groups also were comparable. One laparoscopic case was converted to open. Conclusion: This study demonstrates that IHR can be performed effectively with the robotic-assisted, laparoscopic, or open approaches. There was no difference in the median number of prescription pain medication pills taken between the RAS and laparoscopic groups. A difference was observed in the overall number of patients reporting the need to take prescription pain medication. Comparable operative times were observed for RAS unilateral IHR patients compared to open unilateral IHR patients; however, operative times for RAS overall and bilateral subjects were longer than for open patients. Operative times were longer overall for RAS patients compared to laparoscopic patients; however, there was no difference in conversion and complication rate in the RAS vs. laparoscopic groups or the complication rate in the RAS vs. open group. Time to return to normal activities for RAS IHR patients was comparable to that of laparoscopically repaired patients and significantly sooner compared to open IHR patients.
AB - Purpose: To evaluate and compare peri-operative outcomes through 30 days, including pain and quality of life (QOL) through 3 months across three cohorts of inguinal hernia repair (IHR) patients (robotic-assisted, laparoscopic, and open IHR). Methods: The Prospective Hernia Study is an ongoing, multicenter, comparative, open-label analysis of clinical and patient-reported outcomes from robotic-assisted surgery (RAS) versus open and RAS versus laparoscopic IHR procedures. Patient responses to the Carolinas Comfort Scale (CCS) questionnaire provided QOL outcomes. Results: 504 enrolled patients underwent unilateral or bilateral IHR (RAS, n = 159; open, n = 190; laparoscopic, n = 155) at 17 medical institutions from May 2016 through December 2018. Propensity score matching provided a balanced comparison: RAS versus open (n = 112 each) and RAS versus laparoscopic (n = 80 each). Overall, operative times were significantly different between the RAS and laparoscopic cases (83 vs. 65 min; p < 0.001). Fewer RAS patients required prescription pain medication than either open (49.5% vs. 80.0%; p < 0.001) or laparoscopic patients (45.3% vs. 65.4%; p = 0.013). Median number of prescription pain pills taken differed for RAS vs. open (0.5 vs. 15.5; p = 0.001) and were comparable for RAS vs laparoscopic (7.0 vs. 6.0; p = 0.482) among patients taking prescribed pain medication. Time to return to normal activities differed for RAS vs. open (3 vs. 4 days; p = 0.005) and were comparable for RAS vs. laparoscopic (4 vs. 4 days; p = 0.657). Median CCS scores through 3 months were comparable for the three approaches. Postoperative complication rates for the three groups also were comparable. One laparoscopic case was converted to open. Conclusion: This study demonstrates that IHR can be performed effectively with the robotic-assisted, laparoscopic, or open approaches. There was no difference in the median number of prescription pain medication pills taken between the RAS and laparoscopic groups. A difference was observed in the overall number of patients reporting the need to take prescription pain medication. Comparable operative times were observed for RAS unilateral IHR patients compared to open unilateral IHR patients; however, operative times for RAS overall and bilateral subjects were longer than for open patients. Operative times were longer overall for RAS patients compared to laparoscopic patients; however, there was no difference in conversion and complication rate in the RAS vs. laparoscopic groups or the complication rate in the RAS vs. open group. Time to return to normal activities for RAS IHR patients was comparable to that of laparoscopically repaired patients and significantly sooner compared to open IHR patients.
KW - Inguinal hernia repair
KW - Laparoscopic
KW - Open
KW - Pain
KW - Quality of life
KW - Robotic assisted
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U2 - 10.1007/s10029-020-02224-4
DO - 10.1007/s10029-020-02224-4
M3 - Article
C2 - 32495043
AN - SCOPUS:85085933436
VL - 24
SP - 1069
EP - 1081
JO - Hernia : the journal of hernias and abdominal wall surgery
JF - Hernia : the journal of hernias and abdominal wall surgery
SN - 1265-4906
IS - 5
ER -