Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial).
Da Vinci
DaVinci
Epigastric hernia
Hernia repair
Laparotomy
Mesh
PVHR
Repair
Robot
Technique
Trial
Umbilical hernia
Ventral hernia
Journal
International journal of surgery protocols
ISSN: 2468-3574
Titre abrégé: Int J Surg Protoc
Pays: England
ID NLM: 101758186
Informations de publication
Date de publication:
2020
2020
Historique:
received:
27
01
2020
revised:
23
03
2020
accepted:
24
03
2020
entrez:
6
5
2020
pubmed:
6
5
2020
medline:
6
5
2020
Statut:
epublish
Résumé
The objective of the present study is to compare the outcomes open PVHR and robotic PVHR. The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1-5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence. Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR. The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.
Sections du résumé
BACKGROUND
BACKGROUND
The objective of the present study is to compare the outcomes open PVHR and robotic PVHR.
METHODS/DESIGN
METHODS
The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1-5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence.
DISCUSSION
CONCLUSIONS
Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR.
TRIAL REGISTRATION
BACKGROUND
The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.
Identifiants
pubmed: 32368702
doi: 10.1016/j.isjp.2020.03.004
pii: S2468-3574(20)30011-5
pmc: PMC7186553
doi:
Banques de données
ClinicalTrials.gov
['NCT04171921']
Types de publication
Journal Article
Langues
eng
Pagination
27-31Informations de copyright
© 2020 The Authors.
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