Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Incisional Hernia Clinical Trial

Official title:

Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347642
• Other study ID #: Garcilaso 2020/1
• Status: Recruiting
• Phase: Phase 3
• Start date: July 7, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: July 2020
• Source: Hospital General Universitario Elche
• Contact: Jaime Ruiz-Tovar
• Phone: +34630534808
• Email: jruiztovar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Incisional Hernia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Mexico	Gilberto Gonzalez	Guadalajara
Spain	Jaime Ruiz-Tovar	Madrid	Introducir Provincia O Estado

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Countries where clinical trial is conducted

Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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