Non-Doppler hemorrhoidal artery ligation and hemorrhoidopexy combined with pudendal nerve block for the treatment of hem
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ORIGINAL ARTICLE
Non-Doppler hemorrhoidal artery ligation and hemorrhoidopexy combined with pudendal nerve block for the treatment of hemorrhoidal disease: a non-inferiority randomized controlled trial Konstantinos Perivoliotis 1 & Michail Spyridakis 1 & Elias Zintzaras 2 Manousos-Georgios Pramateftakis 4 & Konstantinos Tepetes 1
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Eleni Arnaoutoglou 3
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Accepted: 1 October 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Background In this study, we proposed a combined outpatient treatment modality for hemorrhoidal disease. Methods This study was a prospective non-inferiority randomized controlled trial (RCT). The experimental group included the dearterialization and hemorrhoidopexy under pudendal nerve block, whereas the comparator consisted of the standard Doppler guided hemorrhoidal artery ligation and hemorrhoidopexy, under spinal anesthesia. As primary hypothesis, we considered the non-inferiority of the proposed modality in terms of the presenting symptom remission rate (non-inferiority margin: 10%). Randomization was based on a 1:1 ratio. Blinding was confined to the patient and the investigator. Results Overall, 60 patients were enrolled. The primary hypothesis of this RCT (96.7% vs 73.3%) was validated. The experimental group was associated with a lower operation duration and an expedited onset of mobilization and feeding. Moreover, a favorable profile regarding short-term morbidity and analgesia was identified. The control group displayed a higher pile recurrence rate and a suboptimal patient satisfaction. A significant effect of the treatment modality in most of the SF-36 components was confirmed. Conclusions The proposed treatment modality was associated with favorable short and long-term outcomes. Due to specific limitations, further RCTs, with a larger sample size, are required. Trial Registration ClinicalTrials.gov: NCT03298997. Keywords Hemorrhoids . Ligation . Hemorrhoidopexy . Ultrasound; pudendal
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00384-020-03768-8) contains supplementary material, which is available to authorized users. * Konstantinos Perivoliotis [email protected]
Konstantinos Tepetes [email protected]
Michail Spyridakis [email protected]
1
Department of Surgery, University Hospital of Larissa, Mezourlo, 41110 Larissa, Greece
Elias Zintzaras [email protected]
2
Department of Biomathematics, School of Medicine, University of Thessaly, Larissa, Greece
Eleni Arnaoutoglou [email protected]
3
Department of Anesthesiology, University Hospital of Larissa, Mezourlo, 41110 Larissa, Greece
Manousos-Georgios Pramateftakis [email protected]
4
Fourth Surgical Department, Medical School, Aristotle University of Thessaloniki, 57010 Thessaloniki, Greece
Int J Colorectal Dis
Introduction
Methods
Rationale
Design
Hemorrhoidal disease is one of the most common perianal conditions [1, 2], with a significant variation in the reported incidence (4–40%) [1–3]. The magnitude of the probl
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