NCT04961346

Brief Summary

In this randomized, controlled, prospective multicentre clinical trial with a parallel group design a large-pore, lightweight polypropylene mesh (Ultrapro®) is compared to a small-pore, heavyweight polypropylene mesh (Premilene®), within a standardized, retromuscular mesh augmentation to identify the superiority of the lightweight mesh. Included patients are examined at five scheduled follow-up visits (5 and 21 days, 4, 12 and 24 months after surgery). The primary outcome criterion is foreign body sensation 12 month after surgery. Further secondary endpoint criteria are the occurrence of haematoma or haematoma requiring surgery at the 5-day visit, seroma, wound infection, and chronic pain within 24 months postoperatively. Quality of life was investigated by the SF-36®.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

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

September 1, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
12 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

2.7 years

First QC Date

June 16, 2021

Last Update Submit

July 16, 2021

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (1)

  • foreign body sensation

    Quality of life measurement based on the occurrence of a foreign body sensation for more than 3 months within 12 month after surgery.

    12 month after surgery

Secondary Outcomes (6)

  • postoperative seroma

    24 month

  • wound infection

    24 month

  • haematoma

    5 days

  • hematoma requiring surgery

    5 days

  • chronic pain

    24 month

  • +1 more secondary outcomes

Study Arms (2)

Ultrapro®

EXPERIMENTAL

Participants received incisional hernia repair with an Ultrapro mesh in a sublay technique.

Device: Ultrapro® mesh

Premilene®

EXPERIMENTAL

Participants received incisional hernia repair with a Premilene mesh in a sublay technique.

Device: Premilene® mesh

Interventions

Ultrapro® meshDEVICE

large-pore, lightweight polypropylene mesh

Ultrapro®
Premilene® meshDEVICE

small-pore, heavyweight polypropylene mesh

Premilene®

Eligibility Criteria

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

You may qualify if:

  • fascial defect after vertical midline laparotomy with a minimum of 4 cm in diameter

You may not qualify if:

  • hernia of other location
  • recurrent hernia
  • incarcerated hernia
  • emergency surgery
  • patients with a malignancy or chemotherapy within the last 3 months
  • pregnancy
  • participation in other studies
  • patients with a wound infection
  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Related Publications (1)

  • Kroh A, Zufacher M, Eickhoff R, Heise D, Helmedag M, Ulmer F, Neumann UP, Conze J, Hilgers RD, Binnebosel M. No difference in outcomes between large- and small-pore meshes in a prospective, randomized, multicenter trial investigating open retromuscular meshplasty for incisional hernia repair. Langenbecks Arch Surg. 2023 Jan 13;408(1):22. doi: 10.1007/s00423-022-02751-x.

    PMID: 36635466DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Ralf D Hilgers, Professor

    Institute for Medical Statistics, RWTH Aachen University Hospital, Aachen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2021

First Posted

July 14, 2021

Study Start

September 1, 2004

Primary Completion

June 1, 2007

Study Completion

June 1, 2009

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

DE(1)