Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
NCT ID: NCT04347642
Last Updated: 2020-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2020-07-07
2021-09-15
Brief Summary
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Patients will be randomized into 2 groups:
* G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port
* G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
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Detailed Description
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Patients will be randomized into 2 groups:
* G1: 12mm Umbilical port will be inserted in the umbilical region, with open access and using a Hasson port. Pneumoperitoneum will be done by this Hasson port.
* G2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. Pneumoperitoneum will be previously done using a Veress needle.
Incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Umbilical port
A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.
Umbilical port placement
The port will be inserted in the midline at the level of the umbilicus.
Paraumbilical port
A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.
Paraumbilical port placement
The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.
Interventions
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Umbilical port placement
The port will be inserted in the midline at the level of the umbilicus.
Paraumbilical port placement
The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.
Eligibility Criteria
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Inclusion Criteria
* Acceptance to participate in the study and sign of informed consent form
Exclusion Criteria
* Coexistence of umbilical hernia or previous umbilical hernioplasty
* Previous laparotomy involving the umbilical region
* Emergency surgery
18 Years
ALL
No
Sponsors
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Hospital General Universitario Elche
OTHER
Responsible Party
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Jaime Ruiz-Tovar, MD, PhD
Clinical Professor
Principal Investigators
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Gilberto Gonzalez
Role: STUDY_CHAIR
Centro PDH
Locations
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Gilberto Gonzalez
Guadalajara, , Mexico
Jaime Ruiz-Tovar
Madrid, Introducir Provincia O Estado, Spain
Countries
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Central Contacts
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Facility Contacts
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Gilberto Gonzalez
Role: primary
Other Identifiers
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Garcilaso 2020/1
Identifier Type: -
Identifier Source: org_study_id
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