Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04347642

Enrollment

180

Registered

2020-04-15

Start date

2020-07-07

Completion date

2021-09-15

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia

Brief 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.

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.

Interventions

PROCEDUREUmbilical port placement

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

PROCEDUREParaumbilical port placement

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incisional hernia at the level of the trocar insertion	12 months after surgery	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.

Countries

Mexico, Spain

Contacts

Primary ContactJaime Ruiz-Tovar

jruiztovar@gmail.com+34630534808

Backup ContactCarolina LLavero

carolinallavero@gmail.com649593020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026