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Prevention of incisional hernia with a reinforced tension line (RTL) versus primary suture only in midline laparotomies: 3-year follow-up in a randomized clinical trial

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Abstract

Purpose

Incisional hernia (IH) has an incidence of 10–23%, which can increase to 38% in specific risk groups. The objective of this study is to report the results at 3 years of follow-up of the use of the reinforced tension line (RTL) technique compared with primary suture only (PSO) closure in the prevention of IH in high-risk patients undergoing laparotomy.

Methods

Open randomized controlled clinical trial. Included were patients older than 18 years who underwent midline laparotomy, emergency or scheduled, who were considered high risk, and who completed 3-year follow-up. The patients were randomized 1:1 to the RTL technique or to PSO. The objective was to report the incidence of IH and the complications associated with the closure method. Intention-to-treat analysis and Cox regression were performed.

Results

A total of 124 patients were randomized; 51 patients from the RTL group and 53 patients from the PSO group finished the 3-year follow-up. The incidence of IH was higher in the PSO group (15/53, 28.3%) than the RTL group (5/51, 9.8%) (p = 0.016, OR 0.35, 95% CI 0.14–0.88, number needed to treat 5.4, log-rank test p = 0.017). The groups were similar in the rates of surgical site infection, hematoma, seroma, and postoperative pain during follow-up.

Conclusions

The RTL technique is useful in the prevention of IH when compared with PSO in high-risk midline laparotomy patients, and it is not associated with a higher percentage of complications.

Trial registration

Local Committee CI-HRAEB-2013-020. March 13, 2013.

Clinical trials

NCT02136628, retrospectively registered.

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Data availability

The database is available for review.

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Author information

Authors and Affiliations

  1. General Surgery, Department of Diseases of the Digestive Tract, Regional Hospital of High Specialty of Bajio, Circuito Quinta los Naranjos # 145 B Colonia Quinta los Naranjos, Leon Guanajuato, Mexico

    E. E. Lozada-Hernández, R. L. Smolinski-Kurek, L. Montiel-Hinojosa, J. M. Morales-Vargas, A. Orozco-Mosqueda & M. Cano-Rosas

  2. General Surgery, Medica Campestre Hospital, Leon Guanajuato, Mexico

    J. C. Mayagoitía-González

  3. General Surgery, Mexican Social Security Institute, Leon Guanajuato, Mexico

    L. Hernández-Villegas

  4. General Practitioner, General Hospital of Guanajuato, Guanajuato, Mexico

    K. D. Pérez-Sánchez

Authors
  1. E. E. Lozada-Hernández
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  2. J. C. Mayagoitía-González
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  8. A. Orozco-Mosqueda
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Contributions

EELH, the lead author, designed the study. JCMG conducted all the interviews and, alongside EELH, undertook the thematic analysis; RLSK, LMH, JMMV, LHV, KDPS, AOM and MCR took part in the schematic analysis. All authors have provided input into drafts of this article. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. All authors have read and approved the manuscript in its final state.

Corresponding author

Correspondence to E. E. Lozada-Hernández.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethics approval

Our study complies with the Code of Ethics of the World Medical Association (Declaration of Helsinki) and the study was approved by the local committee for clinical research and the ethics committee.

Human and animal rights

This article does not contain any studies with animals performed by any of the authors.

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At recruitment, written informed consent was obtained from each subject.

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According to the study publication.

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Lozada-Hernández, E.E., Mayagoitía-González, J.C., Smolinski-Kurek, R.L. et al. Prevention of incisional hernia with a reinforced tension line (RTL) versus primary suture only in midline laparotomies: 3-year follow-up in a randomized clinical trial. Hernia 26, 447–456 (2022). https://doi.org/10.1007/s10029-020-02338-9

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