Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy
1 other identifier
interventional
180
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2020
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
July 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedJuly 9, 2020
July 1, 2020
1.2 years
April 12, 2020
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months after surgery
Study Arms (2)
Umbilical port
ACTIVE COMPARATORA Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.
Paraumbilical port
EXPERIMENTALA bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.
Interventions
The port will be inserted in the midline at the level of the umbilicus.
The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.
Eligibility Criteria
You may qualify if:
- Elective laparoscopic cholecystectomy
- Acceptance to participate in the study and sign of informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Gilberto Gonzalez
Guadalajara, Mexico
Jaime Ruiz-Tovar
Madrid, Introducir Provincia O Estado, 28002, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gilberto Gonzalez
Centro PDH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 12, 2020
First Posted
April 15, 2020
Study Start
July 7, 2020
Primary Completion
September 15, 2021
Study Completion
September 15, 2021
Last Updated
July 9, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share