Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.

Incisional Hernia Clinical Trial

— PSHERNIA  

Official title:

Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495557
• Other study ID #: PORT SITE HERNIA
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2022
• Source: Hospital de Mataró
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.

Description:

Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Laparoscopic cholecystectomy
• Emergent/elective
• =2 risk factors: diabetes mellitus, age =70 years, BMI =30, fascial enlargement

Exclusion Criteria:

• Conversion to laparotomy
• Emergent re intervention
• Immunosuppression
• Umbilical hernia

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• Control
Fascial closure with simple polydioxanone suture 2/0 stitches

Device:
• Experimental
Onlay polypropylene mesh placement (MN mesh)

Locations

Country	Name	City	State
Spain	Hospital de Mataró	Mataró	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Mataró

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Umbilical trocar site hernia incidence	Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)	3 years
Secondary	Seroma incidence	A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)	6 months
Secondary	Hematoma incidence	A localized collection of extravasated blood clotted under the tissue (clinical assessment)	6 months
Secondary	Wound infection incidence	Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically	6 months
Secondary	Pain presence	Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)	6 months, 1 and 3 years
Secondary	Hospital discharge	When patients leave the hospital after the intervention, measured by hours	48 hours
Secondary	Operative time	Intervention duration, measured by minutes	2 hours
Secondary	Return to regular activity	When patient return to job or regular activities after surgery, measured by days	6 months
Secondary	Patient satisfaction	How satisfied/unsatisfied is the patient with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)	3 years
Secondary	Surgeon satisfaction	How satisfied/unsatisfied is the surgeon with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)	3 years