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Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial
INTRODUCTION: Inguinal hernia repairs are commonly performed procedures. The surgical techniques vary from open procedures to minimally invasive and robotic-assisted surgeries and include totally extra-peritoneal hernia repairs (TEP) and robotic transabdominal pre-peritoneal hernia repairs (rTAPP)....
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
IJS Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9187240/ https://www.ncbi.nlm.nih.gov/pubmed/35794884 http://dx.doi.org/10.29337/ijsp.175 |
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author | Angehrn, Fiorenzo V. Neuschütz, Kerstin J. Baur, Johannes Schneider, Romano Wilhelm, Alexander Stoll, Lea Süsstrunk, Julian von Flüe, Markus Bolli, Martin Steinemann, Daniel C. |
author_facet | Angehrn, Fiorenzo V. Neuschütz, Kerstin J. Baur, Johannes Schneider, Romano Wilhelm, Alexander Stoll, Lea Süsstrunk, Julian von Flüe, Markus Bolli, Martin Steinemann, Daniel C. |
author_sort | Angehrn, Fiorenzo V. |
collection | PubMed |
description | INTRODUCTION: Inguinal hernia repairs are commonly performed procedures. The surgical techniques vary from open procedures to minimally invasive and robotic-assisted surgeries and include totally extra-peritoneal hernia repairs (TEP) and robotic transabdominal pre-peritoneal hernia repairs (rTAPP). So far, there is no randomized and blinded clinical trial comparing these two surgical approaches. Our objective is to investigate whether rTAPP is associated with a decreased postoperative level of pain. METHODS: This is a prospective, single center, randomized and blinded clinical trial. Patients will receive either rTAPP or TEP for uni- or bilateral inguinal hernias. All patients and assessors of the study are blinded to the randomization. The perioperative setting is standardized, and all surgeons will perform both rTAPP and TEP to eliminate surgeons` bias. Primary endpoint is the assessment of pain while coughing 24 hours after surgery using the numeric rating scale (NRS). Secondary endpoints include the assessment of multiple pain and quality of life questionnaires at several defined times according to the study schedule. Furthermore, intra- and postoperative complications, duration until discharge, procedure time, duration of postoperative sick leave and the recurrence rate will be evaluated. REGISTRY: The trial has been registered at ClinicalTrials.gov under the registry number NCT05216276. HIGHLIGHTS: Trial comparing robotic and conventional minimal-invasive inguinal hernia repair. Randomized and patient/assessor blinded trial. Early postoperative pain as primary outcome (24 hours). Secondary patient outcomes include pain and quality of life scores up to one year. Further secondary outcomes: complications, costs, surgeon’s stress level; |
format | Online Article Text |
id | pubmed-9187240 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | IJS Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-91872402022-07-05 Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial Angehrn, Fiorenzo V. Neuschütz, Kerstin J. Baur, Johannes Schneider, Romano Wilhelm, Alexander Stoll, Lea Süsstrunk, Julian von Flüe, Markus Bolli, Martin Steinemann, Daniel C. Int J Surg Protoc Protocol INTRODUCTION: Inguinal hernia repairs are commonly performed procedures. The surgical techniques vary from open procedures to minimally invasive and robotic-assisted surgeries and include totally extra-peritoneal hernia repairs (TEP) and robotic transabdominal pre-peritoneal hernia repairs (rTAPP). So far, there is no randomized and blinded clinical trial comparing these two surgical approaches. Our objective is to investigate whether rTAPP is associated with a decreased postoperative level of pain. METHODS: This is a prospective, single center, randomized and blinded clinical trial. Patients will receive either rTAPP or TEP for uni- or bilateral inguinal hernias. All patients and assessors of the study are blinded to the randomization. The perioperative setting is standardized, and all surgeons will perform both rTAPP and TEP to eliminate surgeons` bias. Primary endpoint is the assessment of pain while coughing 24 hours after surgery using the numeric rating scale (NRS). Secondary endpoints include the assessment of multiple pain and quality of life questionnaires at several defined times according to the study schedule. Furthermore, intra- and postoperative complications, duration until discharge, procedure time, duration of postoperative sick leave and the recurrence rate will be evaluated. REGISTRY: The trial has been registered at ClinicalTrials.gov under the registry number NCT05216276. HIGHLIGHTS: Trial comparing robotic and conventional minimal-invasive inguinal hernia repair. Randomized and patient/assessor blinded trial. Early postoperative pain as primary outcome (24 hours). Secondary patient outcomes include pain and quality of life scores up to one year. Further secondary outcomes: complications, costs, surgeon’s stress level; IJS Publishing Group 2022-06-06 /pmc/articles/PMC9187240/ /pubmed/35794884 http://dx.doi.org/10.29337/ijsp.175 Text en Copyright: © 2022 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. See http://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Protocol Angehrn, Fiorenzo V. Neuschütz, Kerstin J. Baur, Johannes Schneider, Romano Wilhelm, Alexander Stoll, Lea Süsstrunk, Julian von Flüe, Markus Bolli, Martin Steinemann, Daniel C. Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial |
title | Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial |
title_full | Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial |
title_fullStr | Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial |
title_full_unstemmed | Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial |
title_short | Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial |
title_sort | robotic versus conventional minimal-invasive inguinal hernia repair: study protocol for a prospective, randomized and blinded clinical trial |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9187240/ https://www.ncbi.nlm.nih.gov/pubmed/35794884 http://dx.doi.org/10.29337/ijsp.175 |
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