Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Phase 3

• Conditions: Incisional Hernia
• Interventions: Procedure: Paraumbilical port placement; Procedure: Umbilical port placement

• Registration Number: NCT04347642
• Lead Sponsor: Hospital General Universitario Elche

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.

Study Timeline

• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-12
• Study First Posted: 2020-04-15
• Status Verified: 2020-07
• Study Start: 2020-07-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paraumbilical port	Paraumbilical port placement	A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.
Umbilical port	Umbilical port placement	A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Gilberto Gonzalez; 🇲🇽 Guadalajara, Mexico

Jaime Ruiz-Tovar; 🇪🇸 Madrid, Introducir Provincia O Estado, Spain