Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Umbilical vs Paraumbilical Trocar Placement in Patients Undergoing Elective Laparoscopic Cholecystectomy

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: Umbilical port placement
* Procedure: Paraumbilical port placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Umbilical port<br>A Hasson port will be inserted at the level of the umbilicus,in the midline, traversing only aponeurotic layers. | Procedure: Umbilical port placement<br>* The port will be inserted in the midline at the level of the umbilicus.<br>|
| Experimental: Paraumbilical port<br>A bladeless 12mm port will be inserted lateral to the midline, traversing aponeurotic layers and rectus abdominis muscle. | Procedure: Paraumbilical port placement<br>* The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia at the level of the trocar insertion | 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. | 12 months after surgery |