Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Last updated: July 7, 2020
Sponsor: Hospital General Universitario Elche
Overall Status: Active - Recruiting

Phase

3

Condition

Hernia

Treatment

N/A

Clinical Study ID

NCT04347642
Garcilaso 2020/1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Elective laparoscopic cholecystectomy

  • Acceptance to participate in the study and sign of informed consent form

Exclusion

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

Total Participants: 180
Study Start date:
July 07, 2020
Estimated Completion Date:
September 15, 2021

Study 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.

Connect with a study center

  • Gilberto Gonzalez

    Guadalajara,
    Mexico

    Active - Recruiting

  • Jaime Ruiz-Tovar

    Madrid, Introducir Provincia O Estado 28002
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.