Comparative Study Matching Intraperitoneal Onlay Mesh (IPOM) and Sublay Mesh to Treat Umbilical Hernia

May 6, 2019 updated by: University Hospital, Basel, Switzerland

Prospective Randomized Multicenter Trial Comparing Laparoscopic (IPOM) vs. Sublay Mesh Plasty for Umbilical Hernia in Adults

This study is designed to compare two techniques for operative care of umbilical hernia in adults regarding wound complications, wound side fluid collections, recurrence rate, postoperative pain, duration of hospitalization and quality of life. The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind the rectus muscle after small incision close to the belly button.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
306

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Niedersachsen
      • Rotenburg, Niedersachsen, Germany, 27356
        • Diakoniekrankenhaus Rotenburg (Wuemme) gGmbH
  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel
      • Luzern, Switzerland, 6000
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • informed consent
  • patient age: ≥ 18 years
  • elective surgery for umbilical hernia
  • hernia diameter ≥ 1cm

Exclusion Criteria:

  • previous history of median laparotomy
  • navel site infection
  • contraindication for general anaesthesia
  • American Society of Anesthesiologists (ASA) score >IV
  • pregnancy
  • cirrhosis of the liver (CHILD B and C) and/or ascites
  • cytostatic therapy
  • incarcerated hernia
  • recurrent hernia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: intraperitoneal onlay mesh repair
Procedure: intraperitoneal onlay mesh repair
The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.
Active Comparator: sublay mesh repair
Procedure: sublay mesh repair
The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
early wound complications
Time Frame: 30 days after operation
  • wound infection (with or without removal of the mesh)
  • wound necrosis
  • wound hematoma
30 days after operation
late wound complications
Time Frame: 1 year after operation
  • wound infection (with or without removal of the mesh)
  • wound necrosis
  • wound hematoma
1 year after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
complication rate perioperative
Time Frame: intraoperative complications will be recorded immediately after finishing the operation
  • major bleeding
  • bowel injury
intraoperative complications will be recorded immediately after finishing the operation
duration of operation
Time Frame: the duration will be recorded immediately after finishing the operation
measured in minutes according to operations protocol (duration cut - suture)
the duration will be recorded immediately after finishing the operation
hospital stay
Time Frame: will be measured after discharge of the patient
measured in days
will be measured after discharge of the patient
umbilical hernia recurrence rate
Time Frame: 30 days
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
30 days
umbilical hernia recurrence rate
Time Frame: 1 year
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
1 year
umbilical hernia recurrence rate
Time Frame: 3 years
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
3 years
umbilical hernia recurrence rate
Time Frame: 5 years
the diagnosis of recurrence will be given by the surgeon clinically or due to ultrasound scan
5 years
navel site seroma
Time Frame: discharge day
the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))
discharge day
navel site seroma
Time Frame: after 30 days
the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))
after 30 days
navel site seroma
Time Frame: after 1 year
the diagnosis of seroma will be given by the surgeon clinically or by ultrasound scan and measured in ccm (height(cm) x width(cm)x length(cm))
after 1 year
complication rate postoperative
Time Frame: 30 day
  • trocar site hernia
  • enteral fistula
  • persistent pain
  • re-operation
30 day
complication rate postoperative
Time Frame: 1 year
  • trocar site hernia
  • enteral fistula
  • persistent pain
  • re-operation
1 year
complication rate postoperative
Time Frame: 3 years
  • trocar site hernia
  • enteral fistula
  • persistent pain
  • re-operation
3 years
complication rate postoperative
Time Frame: 5 years
  • trocar site hernia
  • enteral fistula
  • persistent pain
  • re-operation
5 years
pain score (Visual Analog Scale - VAS)
Time Frame: 24h post operative
will be measured by the nurse according to Visual Analog Scale
24h post operative
pain score (Visual Analog Scale - VAS)
Time Frame: 48h post operative
will be measured by the nurse according to Visual Analog Scale
48h post operative
pain score (Visual Analog Scale - VAS)
Time Frame: immediately before discharge
will be measured by the nurse according to Visual Analog Scale
immediately before discharge
Quality of life (SF-36)
Time Frame: 1 day pre-operative
patients will be asked to fulfill validated SF-36 questionnaire
1 day pre-operative
Quality of life (SF-36)
Time Frame: 30 days postoperatively
patients will be asked to fulfill validated SF-36 questionnaire
30 days postoperatively
Quality of life (SF-36)
Time Frame: 1 year postoperatively
patients will be asked to fulfill validated SF-36 questionnaire
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Trial Unit, University Hospital Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Daniel Oertli, Professor, Departement of General Surgery, University Hospital Basel, Switzerland
  • Study Director: Oleg Heizmann, MD, Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany
  • Principal Investigator: Daniel Matz, MD, Departement of General,- Visceral- and Thoracic Surgery, Diakoniekrankenhaus Rotenburg (Wuemme), Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IPOM-46/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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