MedTrace Logo

Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

NCT04347642 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-07-09

No results posted yet for this 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.

Conditions

  • Incisional Hernia

Interventions

PROCEDURE

Umbilical port placement

The port will be inserted in the midline at the level of the umbilicus.

PROCEDURE

Paraumbilical port placement

The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.

Sponsors & Collaborators

  • Hospital General Universitario Elche

    lead OTHER

Principal Investigators

  • Gilberto Gonzalez · Centro PDH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2021-09-15
Completion
2021-09-15

Countries

  • Mexico
  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04347642 on ClinicalTrials.gov