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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
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 12, 2020
Last Updated
July 7, 2020
Sponsor
Hospital General Universitario Elche
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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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