Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
Primary Purpose
Incisional Hernia
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Umbilical port placement
Paraumbilical port placement
Sponsored by
About this trial
This is an interventional prevention trial for Incisional Hernia
Eligibility Criteria
Inclusion Criteria:
- Elective laparoscopic cholecystectomy
- Acceptance to participate in the study and sign of informed consent form
Exclusion Criteria:
- A gallstone larger than 10mm observed at preoperative ultrasonography
- Coexistence of umbilical hernia or previous umbilical hernioplasty
- Previous laparotomy involving the umbilical region
- Emergency surgery
Sites / Locations
- Gilberto GonzalezRecruiting
- Jaime Ruiz-TovarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Umbilical port
Paraumbilical port
Arm Description
A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.
A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.
Outcomes
Primary Outcome Measures
Incisional hernia at the level of the trocar insertion
The incisional hernia at the level of the umbilical or paraumbilial trocar insertion will be assessed by physical examination, or with ultrasonography in case of doubts.
Secondary Outcome Measures
Full Information
NCT ID
NCT04347642
First Posted
April 12, 2020
Last Updated
July 7, 2020
Sponsor
Hospital General Universitario Elche
1. Study Identification
Unique Protocol Identification Number
NCT04347642
Brief Title
Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
Official Title
Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
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.
Detailed Description
The aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Umbilical port
Arm Type
Active Comparator
Arm Description
A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.
Arm Title
Paraumbilical port
Arm Type
Experimental
Arm Description
A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.
Intervention Type
Procedure
Intervention Name(s)
Umbilical port placement
Intervention Description
The port will be inserted in the midline at the level of the umbilicus.
Intervention Type
Procedure
Intervention Name(s)
Paraumbilical port placement
Intervention Description
The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.
Primary Outcome Measure Information:
Title
Incisional hernia at the level of the trocar insertion
Description
The incisional hernia at the level of the umbilical or paraumbilial trocar insertion will be assessed by physical examination, or with ultrasonography in case of doubts.
Time Frame
12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective laparoscopic cholecystectomy
Acceptance to participate in the study and sign of informed consent form
Exclusion Criteria:
A gallstone larger than 10mm observed at preoperative ultrasonography
Coexistence of umbilical hernia or previous umbilical hernioplasty
Previous laparotomy involving the umbilical region
Emergency surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Ruiz-Tovar
Phone
+34630534808
Email
jruiztovar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina LLavero
Phone
649593020
Email
carolinallavero@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilberto Gonzalez
Organizational Affiliation
Centro PDH
Official's Role
Study Chair
Facility Information:
Facility Name
Gilberto Gonzalez
City
Guadalajara
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilberto Gonzalez
Phone
+52 33 3848 2100
Facility Name
Jaime Ruiz-Tovar
City
Madrid
State/Province
Introducir Provincia O Estado
ZIP/Postal Code
28002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar
Phone
+34630534808
Email
jruiztovar@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
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