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

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

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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia
• Intervention / Treatment: Procedure: Control; Device: Experimental

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Mataró, Barcelona, Spain, 08304
      • Hospital de Mataró

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control; Simple closure	Procedure: Control; Fascial closure with simple polydioxanone suture 2/0 stitches
EXPERIMENTAL: Experimental; Simple closure + mesh	Device: Experimental; Onlay polypropylene mesh placement (MN mesh)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma incidence	A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)	6 months
Hematoma incidence	A localized collection of extravasated blood clotted under the tissue (clinical assessment)	6 months
Wound infection incidence	Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically	6 months
Pain presence	Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)	6 months, 1 and 3 years
Hospital discharge	When patients leave the hospital after the intervention, measured by hours	48 hours
Operative time	Intervention duration, measured by minutes	2 hours
Return to regular activity	When patient return to job or regular activities after surgery, measured by days	6 months
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
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

Collaborators and Investigators

• Sponsor: Hospital de Mataró
• Investigators: Principal Investigator: Ana Ciscar, MD, Hospital de Mataró

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 1, 2020
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: March 23, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (ACTUAL): April 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cholecystectomy; Hernia; Mesh fixation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: PORT SITE HERNIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No