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Transvaginal hybrid NOTES cholecystectomy—results of a randomized clinical trial after 6 months

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An Erratum to this article was published on 02 July 2016

Abstract

Introduction

For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2–3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy.

Methods

To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains “satisfaction” and “pain” of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months.

Results

Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P = 0.004 and P < 0.001). There were no postoperative pathological gynecological findings.

Conclusions

Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.

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Acknowledgments

The authors thank PD Dr. S. Sauerland of the Institute for Research in Operative Medicine (IFOM), Cologne, Witten/Herdecke University, for his assistance with the design of this study, Prof. Dr. Prof. h.c. E. A. M. Neugebauer of the IFOM, Cologne, Witten/Herdecke University, for his support in the preparation of this manuscript, and Philipp Rossbach, Dallas, Texas, Dipl.-Dolm. Christina Wagner, Witten/Herdecke University, and Prof. Thomas Banchoff, Georgetown University, for proofreading. The authors also thank all participating patients.

Conflicts of interest

Dirk Rolf Bulian, Jurgen Knuth, Nicola Cerasani, Jonas Lange, Michael Alfred Ströhlein, Axel Sauerwald, and Markus Maria Heiss have no conflicts of interest or financial ties to disclose.

Author information

Authors and Affiliations

  1. Department of Abdominal, Vascular and Transplant Surgery, Cologne-Merheim Medical Center, Witten/Herdecke University, Ostmerheimer Strasse 200, 51109, Cologne, Germany

    Dirk Rolf Bulian, Jurgen Knuth, Nicola Cerasani, Jonas Lange, Michael Alfred Ströhlein & Markus Maria Heiss

  2. Department of General, Visceral, Vascular and Thoracic Surgery, Clinic of Kempten, Robert-Weixler-Strasse 50, 87439, Kempten, Germany

    Jurgen Knuth

  3. Department for Obstetrics and Gynecology, Holweide Hospital, Neufelder Strasse 32, 51067, Cologne, Germany

    Axel Sauerwald

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  1. Dirk Rolf Bulian
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  2. Jurgen Knuth
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  7. Markus Maria Heiss
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Corresponding author

Correspondence to Dirk Rolf Bulian.

Additional information

The trial is supported, in part, by the German Ministry of Research and Education (CHIR-Net grant, BMBF No. 01-GH-0605).

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Bulian, D.R., Knuth, J., Cerasani, N. et al. Transvaginal hybrid NOTES cholecystectomy—results of a randomized clinical trial after 6 months. Langenbecks Arch Surg 399, 717–724 (2014). https://doi.org/10.1007/s00423-014-1218-2

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  • DOI: https://doi.org/10.1007/s00423-014-1218-2

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