Cervical Detachment Using Monopolar SupraLoop™ Electrode versus Monopolar Needle in Laparoscopic Supracervical Hysterectomy (LSH): An Interventional, Comparative Cohort Study

 

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Abstract

Objective: Currently available monopolar loop electrodes are difficult to handle in laparoscopic supracervical hysterectomy (LSH) and are entirely disposable devices, generating additional operating costs. The aim of this interventional study was the comparison of the efficiency and safety of cervical detachment with a newly developed monopolar loop electrode (SupraLoop™) with a conventional method of cervical detachment in LSH.
Material and Methods: Our study sample included 1598 patients; 1070 patients that underwent LSH with cervical detachment using the monopolar SupraLoop™ (study group) and 528 patients that underwent LSH with cervical detachment using the monopolar needle (control group). We also assessed cervical detachment time and total device application and cutting time in a subgroup of 49 patients (23 patients from the study group and 26 patients from the control group).
Results: Total operation time for LSH was significantly shorter among SupraLoop™ patients (93 ± 41 minutes) when compared to patients in whom cervical detachment was performed with the needle (105 ± 44 minutes) (p < 0.001). Cervical detachment time and total device application including cutting time was significantly shorter for the SupraLoop™ group (SupraLoop vs. needle; 0.12 ± 0.21 min vs. 5.1 ± 4.4 min [p < 0.001]; 2.3 ± 1.8 min vs. 5.4 ± 2.4 min [p < 0.001]). There were no major or minor complications directly related to the use of the SupraLoop™ device, whereas two intraoperative complications were directly related to the application of the monopolar needle.
Conclusion: The newly developed monopolar loop electrode (SupraLoop™) is both an effective and safe instrument for cervical detachment in laparoscopic supracervical hysterectomy, and performed better than the needle, offering a significantly shorter operating time and less complications for the hysterectomy compared to the conventional method.

Zusammenfassung

Ziel: Viele der derzeit verfügbaren monopolaren Loop-Elektroden für die laparoskopische suprazervikale Hysterektomie (LSH) sind schwierig zu handhaben und sind Einwegartikel, die dadurch zu einer Erhöhung der Behandlungskosten führen. Das Ziel dieser interventionellen Studie war die Analyse der Effektivität und Sicherheit der Zervixdurchtrennung mittels der neu entwickelten monopolaren Schlingenelektrode (SupraLoop™) mit der konventionellen Methode mit der Nadelelektrode bei der LSH.
Material und Methode: Interventionelle Kohortenstudie. In unsere Studie wurden 1598 Patientinnen eingeschlossen; bei 1070 wurde die Durchtrennung der Zervix bei der LSH mit der monopolaren SupraLoop™ (Studiengruppe) durchgeführt, bei 528 Patientinnen wurde bei der LSH die Zervix mit der monopolaren Nadelelektrode (Kontrollgruppe) durchtrennt. In einer Subgruppe von 49 Patientinnen wurde zudem die Zeit, die zur Durchtrennung der Zervix notwendig war, sowie die gesamte Applikationszeit und die Zervix-Durchtrennungszeit evaluiert (23 Patientinnen der Studiengruppe und 26 Patientinnen der Kontrollgruppe).
Ergebnisse: Die Gesamtoperationszeit der LSH war signifikant kürzer in der SupraLoop™-Gruppe (93 ± 41 min) im Vergleich zur Durchtrennung der Zervix mit der monopolaren Nadelelektrode (105 ± 44 min) (p < 0,001). Die Zeit zur Durchtrennung der Zervix, die gesamte Applikationszeit und Zervix-Durchtrennungszeit war signifikant kürzer in der SupraLoop™-Gruppe (SupraLoop vs. Nadel; 0,12 ± 0,21 min vs. 5,1 ± 4,4 min [p < 0,001]); 2,3 ± 1,8 min vs. 5,4 ± 2,4 min [p < 0.001]). Es wurden weder leichte noch schwere Komplikationen in direktem Zusammenhang mit dem Einsatz der SupraLoop™ beobachtet.
Zusammenfassung: Die neue monopolare Schlingenelektrode (SupraLoop™) ist sowohl effektiv als auch sicher in der Durchtrennung der Zervix bei der laparoskopischen suprazervikalen Hysterektomie. Sie ist der konventionellen Nadelelektrode überlegen, indem sie schnellere Operationszeiten bei einer niedrigeren Komplikationsrate ermöglicht.

^* These authors contributed equally to this work.

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