Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Incisional Hernia

Treatments: Procedure: Umbilical port placement; Procedure: Paraumbilical port placement

Study type: Interventional

Funder types: Other

Identifiers

NCT04347642

Garcilaso 2020/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Umbilical port

Active Comparator group

Description:

A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers.

Treatment:

Procedure: Umbilical port placement

Paraumbilical port

Experimental group

Description:

A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle.

Treatment:

Procedure: Paraumbilical port placement