NCT03495557

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2.9 years

First QC Date

March 23, 2018

Last Update Submit

March 22, 2022

Conditions

Incisional Hernia

Keywords

HerniaCholecystectomyMesh fixation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Seroma incidence

    6 months

  • Hematoma incidence

    6 months

  • Wound infection incidence

    6 months

  • Pain presence

    6 months, 1 and 3 years

  • Hospital discharge

    48 hours

  • +4 more secondary outcomes

Study Arms (2)

Control

SHAM COMPARATOR

Simple closure

Procedure: Control

Experimental

EXPERIMENTAL

Simple closure + mesh

Device: Experimental

Interventions

ControlPROCEDURE

Fascial closure with simple polydioxanone suture 2/0 stitches

Control
ExperimentalDEVICE

Onlay polypropylene mesh placement (MN mesh)

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Related Publications (1)

  • Ciscar A, Sanchez-Saez E, Vila Tura M, Ruiz de Leon P, Gomez Pallares M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA, Badia JM. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial. Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29.

    PMID: 39207550DERIVED

MeSH Terms

Conditions

Incisional HerniaHernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Ana Ciscar, MD

    Hospital de Mataró

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Control will have simple closure while experimental group will have simple closure+mesh
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 12, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2020

Study Completion

September 1, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

ES(1)