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Robotic-assisted, laparoscopic, and open incisional hernia repair: early outcomes from the Prospective Hernia Study

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Abstract

Purpose

To provide a comparative analysis of short-term outcomes after open, laparoscopic, and robotic-assisted (RAS) ventral incisional hernia (VIH) repairs that include subject-reported pain medication usage and hernia-related quality of life (QOL).

Methods

Subjects were ≥ 18 years old and underwent elective open, laparoscopic or RAS VIH repair without myofascial release. Perioperative clinical outcomes through 30 days were analyzed as were prescription pain medication use and subject-reported responses to the HerQLes Abdominal QOL questionnaire. Observed differences in baseline characteristics were controlled using a weighted propensity score analysis to obviate potential selection bias (inverse probability of treatment weighting, IPTW). A p value < 0.05 was considered statistically significant.

Results

Three hundred and seventy-one subjects (RAS, n = 159; open, n = 130; laparoscopic, n = 82) were enrolled in the study across 17 medical institutions within the United States. Operative times were significantly different between the RAS and laparoscopic groups (126.2 vs 57.2, respectively; p < 0.001). Mean length of stay was comparable for RAS vs laparoscopic (1.4 ± 1.0 vs 1.4 ± 1.1, respectively; p = 0.623) and differed for the RAS vs open groups (1.4 ± 1.0 vs 2.0 ± 1.9, respectively; p < 0.001). Conversion rates differed between RAS and laparoscopic groups (0.6% vs 4.9%; p = 0.004). The number of subjects reporting the need to take prescription pain medication through the 2–4 weeks visit differed between RAS vs open (65.2% vs 79.8%; p < 0.001) and RAS vs laparoscopic (65.2% vs 78.75%; p < 0.001). For those taking prescription pain medication, the mean number of pills taken was comparable for RAS vs open (23.3 vs 20.4; p = 0.079) and RAS vs laparoscopic (23.3 vs 23.3; p = 0.786). Times to return to normal activities and to work, complication rates and HerQLes QOL scores were comparable for the RAS vs open and RAS vs laparoscopic groups. The reoperation rate within 30 days post-procedure was comparable for RAS vs laparoscopic (0.6% vs 0%; p = 0.296) and differed for RAS vs open (0.6% vs 3.1%; p = 0.038).

Conclusions

Short-term outcomes indicate that open, laparoscopic, and robotic-assisted approaches are effective surgical approaches to VIH repair; however, each repair technique may demonstrate advantages in terms of clinical outcomes. Observed differences in the RAS vs laparoscopic comparison are longer operative time and lower conversion rate in the RAS group. Observed differences in the RAS vs open comparison are shorter LOS and lower reoperation rate through 30 days in the RAS group. The operative time in the RAS vs open comparison is similar. The number of subjects requiring the use of prescription pain medication favored the RAS group in both comparisons; however, among subjects reporting a need for pain medication, there was no difference in the number of prescription pain medication pills taken. While the study adds to the body of evidence evaluating the open, laparoscopic, and RAS approaches, future controlled studies are needed to better understand pain and QOL outcomes related to incisional hernia repair.

Trial registration

ClinicalTrials.gov identifier: NCT02715622.

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Acknowledgements

We thank the participating investigators in the Prospective Hernia Study Group, and their staff for their involvement in this study. We would also like to acknowledge Intuitive Surgical, Inc. for its sponsorship and funding of the study and, specifically, Jennifer Mueller, MS, Monica Shah, MD and Sundeep Master, BS MBA (Intuitive Surgical, Inc.) for their clinical trial operational support; Dongjing Guo, MPH (Intuitive Surgical, Inc.) for statistical analysis; and Mimi Wainwright (Wainwright Medical Communications, Los Gatos, CA) for medical writing support. The members of the Prospective Hernia Study Group are: Courtney Balentine, MD, MPH; Thai Pham, MD FACS; Valerie-Sue Emuakhagbon, MD; Sergio Huerta, MD FACS (Dallas Veterans Affairs, Dallas, TX); Amy Banks-Venegoni, MD; Lora Silverman, MD; David Scheeres, MD; Thomas Martin, MD (Spectrum Health Medical Group, Grand Rapids, MI); Elliott Brill, MD; Jemmy Hwang, MD; Justin Choi, MD; John Stevenson, MD; Jong-Ping Lu, MD; Amid Keshavarzi, MD, FACS; Judith Keddington, MD, FACS; Maureen Tedesco, MD, FACS; Rouzbeh Mostaedi, MD; David Nguyen, MD; Lisa Yang, MD; Albert Im, MD; Jonathan Svahn, MD; Melissa Chu, MD, FACS; Aaron Baggs, MD, FACS (Kaiser Permanente of Northern California, Santa Clara, CA); Eugene Dickens, MD; Michael McGee, MD, FACS (Hillcrest Medical Center, Tulsa, OK); Reza Gamagami, MD, FACS (Progressive Surgical Associates, New Lenox, IL); Anthony Gonzalez, MD, FACS, FASMBS; Jorge Rabaza, MD, FACS; Juan-Carlos Verdeja, MD, FACS (Baptist Health South Florida, Miami, FL); William Hope, MD, FACS (New Hanover Regional Medical Center, Wilmington, NC); Brian Jacob, MD, FACS; Anthony Vine, MD, FACS; Mark Reiner, MD; Brian Katz, MD (Mount Sinai Medical Center, New York, NY); Karl LeBlanc, MD, MBA, FACS, FASMBS; Keith Rhynes, MD, MBA, FACS (Our Lady of the Lake Hospital, Baton Rouge, LA); Adrian Martin, MD, FACS (Southern Illinois Medical Center, Carbondale, IL); Keith Millikan, MD (Rush University Medical Center, Chicago, IL); John Olsofka, MD (Louisville Surgical Associates, Louisville, KY); Carlos Ortiz-Ortiz, MD, FACS; Eduardo Parra-Davila, MD, FACS, FASCRS (Advent Health, Celebration, FL); Richard Pierce, MD, PhD, FACS (Vanderbilt University Medical Center, Nashville, TN); Thomas Swope, MD, FACS; Kelly Alexander, MD; Phuong Nguyen, MD (Mercy Medical Center, Baltimore, MD); Shirin Towfigh, MD, FACS; (Beverly Hills Hernia Center, Beverly Hills, CA); Guy Voeller, MD; Nathaniel Stoikes, MD; David Webb, MD (University of Tennessee, Memphis, TN).

Funding

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.

Author information

Authors and Affiliations

  1. Our Lady of the Lake Regional Medical Center, 7777 Hennessy Blvd., Suite 612, Baton Rouge, LA, 70808, USA

    K. A. LeBlanc

  2. Baptist Health South Florida, Miami, FL, USA

    A. Gonzalez & J.-C. Verdeja

  3. Hillcrest Medical Center, Tulsa, OK, USA

    E. Dickens

  4. Louisville Surgical Associates, Louisville, KY, USA

    J. Olsofka

  5. Advent Health, Celebration, FL, USA

    C. Ortiz-Ortiz

  6. Vanderbilt University Medical Center, Nashville, TN, USA

    R. Pierce

Authors
  1. K. A. LeBlanc
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  2. A. Gonzalez
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  3. E. Dickens
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  4. J. Olsofka
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  5. C. Ortiz-Ortiz
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  6. J.-C. Verdeja
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  7. R. Pierce
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Consortia

the Prospective Hernia Study Group

Corresponding author

Correspondence to K. A. LeBlanc.

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Conflict of interest

Drs. Dickens, Gonzalez, LeBlanc, Olsofka, Pierce, Ortiz-Ortiz, and Verdeja received clinical research grants from Intuitive Surgical. Drs. Dickens and LeBlanc receive personal fees for consulting and education from Intuitive. Dr. Gonzales 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 of the submitted work. Dr. Ortiz-Ortiz receives personal fees from Medtronic. Drs. Olsofka and Verdeja do not have other conflicts of interest to disclose.

Ethical approval

Ethical approval was agreed by the ethical committee of the institution.

Human and animal rights

The study including human participants has been performed in accordance with the ethical standards of the Declaration of Helsinki and its later amendments.

Informed consent

Informed consent was obtained from all patients prior to surgical procedures.

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The members of the Prospective Hernia Study Group are listed in “Acknowledgements”.

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LeBlanc, K.A., Gonzalez, A., Dickens, E. et al. Robotic-assisted, laparoscopic, and open incisional hernia repair: early outcomes from the Prospective Hernia Study. Hernia 25, 1071–1082 (2021). https://doi.org/10.1007/s10029-021-02381-0

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  • DOI: https://doi.org/10.1007/s10029-021-02381-0

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