Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Unknown
• Conditions: Incisional Hernia
• Intervention / Treatment: Procedure: Umbilical port placement; Procedure: Paraumbilical port placement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jaime Ruiz-Tovar; Phone Number: +34630534808; Email: jruiztovar@gmail.com
• Study Contact Backup: Name: Carolina LLavero; Phone Number: 649593020; Email: carolinallavero@gmail.com

Study Locations

• Mexico
  • Guadalajara, Mexico
    • Recruiting
    • Gilberto Gonzalez
    • Contact: Gilberto Gonzalez; Phone Number: +52 33 3848 2100
• Spain
  • Introducir Provincia O Estado
    • Madrid, Introducir Provincia O Estado, Spain, 28002
      • Recruiting
      • Jaime Ruiz-Tovar
      • Contact: Jaime Ruiz-Tovar; Phone Number: +34630534808; Email: jruiztovar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Umbilical port; A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.	Procedure: Umbilical port placement; The port will be inserted in the midline at the level of the umbilicus.
Experimental: Paraumbilical port; A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.	Procedure: Paraumbilical port placement; The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche
• Investigators: Study Chair: Gilberto Gonzalez, Centro PDH

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Anticipated): September 15, 2021
• Study Completion (Anticipated): September 15, 2021

Study Registration Dates

• First Submitted: April 12, 2020
• First Submitted That Met QC Criteria: April 12, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: Garcilaso 2020/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No