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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04347642
Other study ID # Garcilaso 2020/1
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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