Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial

Andy Schmitt, Patrice Crochet, Karine Baumstark, Claire Tourette, Sabine Poizac, Audrey Pivano, Léon Boubli, Ludovic Cravello, Aubert Agostini, Andy Schmitt, Patrice Crochet, Karine Baumstark, Claire Tourette, Sabine Poizac, Audrey Pivano, Léon Boubli, Ludovic Cravello, Aubert Agostini

Abstract

Background: Laparoscopic surgery has become the preferred surgical approach due to a reduction in postoperative pain, better recovery, shorter hospitalization, and improved esthetic outcomes. Laparoscopic surgery with single-port laparoscopy (SPL) is a laparoscopic surgery technique that is based on making a single parietal incision using a single trocar specifically designed to allow introduction of several instruments. The level of evidence regarding the advantages of SPL in terms of postoperative pain has remained low despite several randomized studies. Adult patients exhibiting a surgical indication for an a priori benign ovarian pathology or for prophylactic purposes that can be performed by laparoscopy will be randomized to receive conventional laparoscopy (CL) or SPL. The aim of our study is to evaluate whether SPL offers advantages over CL in benign adnexal surgery.

Methods: The patients will be evaluated preoperatively to confirm their eligibility. The perioperative data up to 24 h after the intervention, as well as the postoperative data at day 7 and at one month from the intervention will be collected. The primary outcome for the study will be the postoperative pain at 24 h ± 2 h after the intervention. The pain will be assessed by a numeric rating scale of 0-10. Other outcomes will also be assessed, such as pain at other times, the consumption of analgesics, the operative time, perioperative bleeding, the number of additional trocars in the two groups, the incidence of laparoconversion, the esthetic criteria of the scar at one month, the incidence of complications, and the quality of life at one month.

Discussion: If our hypothesis is confirmed, this study will provide evidence that the use of SPL can decrease postoperative pain in adnexal surgery. The standard surgical treatment of this condition would thus be modified.

Trial registration: ClinicalTrials.gov, NCT02739724 . Registered on 12 April 2016.

Keywords: Adnexal pathology; Laparoscopy; Monotrocar; Single incision; Single port.

Conflict of interest statement

Ethics approval and consent to participate

The study obtained approval from the “Comité de Protection des Personnes” (CPP) Sud Méditerranée I (no. 15109) (CPP) on 16 December 2015 and the National Agency for the Safety of Medications (ANSM) on 6 October 2015. This study will be conducted in accordance with the declaration of Helsinki.

Consent for publication

In case the patient agrees to be included in the study, written consent will be obtained before they are taken into the operating theatre.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the trial
Fig. 2
Fig. 2
The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure

References

    1. Nieboer TE1, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677. doi:10.1002/14651858.CD003677.pub4.
    1. Fader AN, Rojas-Espaillat L, Ibeanu O, Grumbine FC, Escobar PF. Laparoendoscopic single-site surgery (LESS) in gynecology: a multi-institutional evaluation. Am J Obstet Gynecol. 2010;203(5):501.e1–6. doi: 10.1016/j.ajog.2010.06.028.
    1. Gunderson CC, Knight J, Ybanez-Morano J, Ritter C, Escobar PF, Ibeanu O, et al. The risk of umbilical hernia and other complications with laparoendoscopic single-site surgery. J Minim Invasive Gynecol. 2012;19(1):40–45. doi: 10.1016/j.jmig.2011.09.002.
    1. Chou L-Y, Sheu B-C, Chang D-Y, Huang S-C, Chen S-Y, Hsu W-C, et al. Comparison between transumbilical and transabdominal ports for the laparoscopic retrieval of benign adnexal masses: a randomized trial. Eur J Obstet Gynecol Reprod Biol. 2010;153(2):198–202. doi: 10.1016/j.ejogrb.2010.07.029.
    1. Kim T-J, Lee Y-Y, Kim MJ, Kim CJ, Kang H, Choi CH, et al. Single port access laparoscopic adnexal surgery. J Minim Invasive Gynecol. 2009;16(5):612–615. doi: 10.1016/j.jmig.2009.06.011.
    1. Canes D, Desai MM, Aron M, Haber G-P, Goel RK, Stein RJ, et al. Transumbilical single-port surgery: evolution and current status. Eur Urol. 2008;54(5):1020–1029. doi: 10.1016/j.eururo.2008.07.009.
    1. Mereu L, Angioni S, Melis GB, Mencaglia L. Single access laparoscopy for adnexal pathologies using a novel reusable port and curved instruments. Int J Gynaecol Obstet Off Organ Int Fed Gynaecol Obstet. 2010;109(1):78–80. doi: 10.1016/j.ijgo.2009.11.012.
    1. Marcelli M, Lamourdedieu C, Lazard A, Cravello L, Gamerre M, Agostini A. Salpingectomy for ectopic pregnancy by transumbilical single-site laparoscopy with the SILS system. Eur J Obstet Gynecol Reprod Biol. 2012;162(1):67–70. doi: 10.1016/j.ejogrb.2012.01.006.
    1. Lazard A, Cravello L, Poizac S, Gorin-Lazard A, Gamerre M, Agostini A. Hysterectomy and bilateral adnexectomy by laparoscopic single port access for female to male transsexualism. J Sex Med. 2013;10(5):1439. doi: 10.1111/jsm.12091.
    1. Poizac S, Estrade J-P, Marcelli M, Lazard A, Cravello L, Blanc B, et al. Single laparoscopic access: initial experience. Gynécologie Obstétrique Fertil. 2011;39(10):541–544. doi: 10.1016/j.gyobfe.2011.08.027.
    1. Fader AN, Escobar PF. Laparoendoscopic single-site surgery (LESS) in gynecologic oncology: technique and initial report. Gynecol Oncol. 2009;114(2):157–161. doi: 10.1016/j.ygyno.2009.05.020.
    1. Fanfani F, Fagotti A, Gagliardi ML, Monterossi G, Rossitto C, Costantini B, et al. Minilaparoscopic versus single-port total hysterectomy: a randomized trial. J Minim Invasive Gynecol. 2013;20(2):192–197. doi: 10.1016/j.jmig.2012.11.007.
    1. De Poncheville L, Smirnoff A, Ménard J, Corbineau G, Vié-Buret V, Nohra O, et al. Feasibility of laparoendoscopic single-site surgery in gynecology with conventional laparoscopic instruments. Gynécologie Obstétrique Fertil. 2012;40(12):729–733. doi: 10.1016/j.gyobfe.2012.09.003.
    1. Lamourdedieu C, Rua S, Lazard A, Marcelli M, Cravello L, Gamerre M, et al. Surgical treatment of ectopic pregnancy by single port access with SILS® system: preliminary study. J Gynécologie Obstétrique Biol Reprod. 2011;40(7):620–625. doi: 10.1016/j.jgyn.2011.06.006.
    1. Kim MK, Kim JJ, Choi JS, Eom JM, Lee JH. Prospective comparison of single port versus conventional laparoscopic surgery for ectopic pregnancy. J Obstet Gynaecol Res. 2015;41(4):590–595. doi: 10.1111/jog.12595.
    1. Hoyer-Sørensen C, Vistad I, Ballard K. Is single-port laparoscopy for benign adnexal disease less painful than conventional laparoscopy? A single-center randomized controlled trial. Fertil Steril. 2012;98(4):973–979. doi: 10.1016/j.fertnstert.2012.06.016.
    1. Cho YJ, Kim M-L, Lee SY, Lee HS, Kim JM, Joo KY. Laparoendoscopic single-site surgery (LESS) versus conventional laparoscopic surgery for adnexal preservation: a randomized controlled study. Int J Womens Health. 2012;4:85–91. doi: 10.2147/IJWH.S29761.
    1. Fagotti A, Bottoni C, Vizzielli G, Gueli Alletti S, Scambia G, Marana E, et al. Postoperative pain after conventional laparoscopy and laparoendoscopic single site surgery (LESS) for benign adnexal disease: a randomized trial. Fertil Steril. 2011;96(1):255–9.e2. doi: 10.1016/j.fertnstert.2011.04.006.
    1. Im K-S, Koo Y-J, Kim J-B, Kwon Y-S. Laparoendoscopic single-site surgery versus conventional laparoscopic surgery for adnexal tumors: a comparison of surgical outcomes and postoperative pain outcomes. Kaohsiung J Med Sci. 2011;27(3):91–95. doi: 10.1016/j.kjms.2010.10.001.
    1. Yoo E-H, Shim E. Single-port access compared with three-port laparoscopic adnexal surgery in a randomized controlled trial. J Int Med Res. 2013;41(3):673–680. doi: 10.1177/0300060513484437.
    1. Yoon BS, Kim YS, Seong SJ, Song T, Kim M-L, Kim MK, et al. Impact on ovarian reserve after laparoscopic ovarian cystectomy with reduced port number: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014;176:34–38. doi: 10.1016/j.ejogrb.2014.02.025.
    1. Schmitt A, Crochet P, Knight S, Tourette C, Loundou A, Agostini A. Single-port laparoscopy vs conventional laparoscopy in Benign adnexal diseases: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2017;24(7):1083–1095. doi: 10.1016/j.jmig.2017.07.001.
    1. Collège national des gynécologues et obstétriciens français. Recommandations pour la pratique clinique: Les tumeurs de l’ovaire présumées bénignes. . Accessed 18 Aug 2017.
    1. Institut National Du Cancer. Oncogénétique ou Cancers avec prédispositions génétiques - Recommandations et outils d’aide à la pratique | Institut National Du Cancer. . Accessed 6 Sept 2017.
    1. Société française d’anesthésie et de réanimation. RECOMMANDATIONS FORMALISÉES D’EXPERTS Prise en charge anesthésique des patients en hospitalisation ambulatoire. . Accessed 18 Aug 2017.
    1. Querleu D. Chirurgie de la trompe et de l'ovaire. En dehors de la grossesse extra-utérine et de la stérilité. Encycl Méd Chir (Elsevier, Paris), Techniques chirurgicales - Gynécologie. 1999;41-520. 8p.
    1. Masson E. Traitement chirurgical des tumeurs bénignes de l’ovaire (hors endométriomes) [Internet]. EMConsulte. [cited 2018 Jan 7]. Available from: .
    1. Phillips MS, Marks JM, Roberts K, Tacchino R, Onders R, DeNoto G, et al. Intermediate results of a prospective randomized controlled trial of traditional four-port laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy. Surg Endosc. 2012;26(5):1296–1303. doi: 10.1007/s00464-011-2028-z.
    1. Rubay R, Hauters P, Valverde A, Delaby J, Saint Marc O, Bokobza B, et al. Single umbilical incision laparoscopic cholecystectomy: results of the prospective trial of the Coelio Club. J Visc Surg. 2012;149(6):417–420. doi: 10.1016/j.jviscsurg.2012.10.017.

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