Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias (AWARE)

February 10, 2024 updated by: Johannes Lauscher, Charite University, Berlin, Germany

Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias

Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities.

Study Overview

Status

Status

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

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.

Detailed Description

Incisional hernias are one of the most frequent complications in abdominal surgery. In Germany, 44.000 incisional hernia repairs per year are performed. Incisional hernia repair is not a low risk operation associated with high recurrence rate and high percentage of postoperative pain. Treatment of incisional hernias represents a significant surgical and socioeconomic problem. Until now, surgical treatment is recommended for patients with incisional hernia independent of symptoms due to the risk of an acute incarceration with serious complications. Studies defining the exact indications for incisional hernia repair and describing the natural course of an incisional hernia including the risk of an acute incarceration are not available to date. Randomized controlled trials having been performed in the past few years show that observation is a reasonable option in mildly symptomatic inguinal hernias. In this study, watchful waiting vs. surgical repair of oligosymptomatic incisional hernias are compared in a prospective-randomized setting for the first time.

The primary endpoint is pain during normal activities measured on the Surgical Pain Scales (SPS) after 24 months follow-up. SPS are a numeric analog scale (NAS) from 0 (no pain) to 150 (maximal pain). The primary endpoint will be dichotomized to no/minimal pain (SPS 0-30) and pain interfering with everyday activities (SPS > 30). Watchful waiting is non-inferior to surgical repair in case the upper border of the 95 % confidence interval will not include the value of 2.

Secondary outcomes are pain and discomfort during during sports, at rest, patient satisfaction, quality of life, and the frequency of incarceration. The investigators hypothesize that pain intensity during everyday activities is not different in the compared groups and that incarceration frequency is low. If this was the case, a watchful waiting strategy could be applied in oligosymptomatic incisional hernias and risks and costs for surgery could be saved.

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.
636

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.
  • Not Applicable

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
      • Berlin, Germany, 12200
        • Charite Campus Benjamin Franklin

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age ≥18 years
  • asymptomatic/ oligosymptomatic incisional hernia

Exclusion Criteria:

  • no hernia detectable by physical examination
  • acute incarcerated hernia
  • emergency hernia repair
  • pain or discomfort associated with the hernia during normal activities
  • local or systemic infection
  • ASA score >3
  • inability to complete or comprehend the preoperative questionnaire
  • repair with biologic prothesis

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: Single

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.
Experimental: watchful waiting

After informed consent and randomization into the watchful waiting group patients will receive standardized verbal information and written instructions on symptoms of acute incarceration. In case of acute symptoms they will be told to visit a physician immediately. On follow-up visits at 1 month, 12 months and 24 months the hernia size will be determined by physical examination, and the pain/ discomfort and the functional status will be monitored.

Control intervention/ reference test:

Open or laparoscopic hernia repair with mesh (non-absorbable or partly-absorbable alloplastic material) or with direct suture repair. For hernias measuring ≥ 3 cm mesh repair is recommended. A wide overlap of the mesh over the fascia margin on each side has to be provided. Divergent types of repair are permitted but have to be documented.
Other: Watchful waiting
Watchful waiting means the observation of the hernia. The patient is informed about signs of deterioration or incarceration. The hernia is controlled clinically on defined follow-up visits.
Active Comparator: Hernia repair
Intervention: Open or laparoscopic hernia repair with mesh (non-absorbable or partly-absorbable alloplastic material) or with direct suture repair. For hernias measuring ≥ 3 cm mesh repair is recommended. A wide overlap of the mesh over the fascia margin on each side has to be provided. Divergent types of repair are permitted but have to be documented.
Procedure: Hernia repair

Open or laparoscopic hernia repair with mesh (non-absorbable or partly-absorbable alloplastic material) or with direct suture repair. For hernias measuring ≥ 3 cm mesh repair is recommended. A wide overlap of the mesh over the fascia margin on each side has to be provided.

These are all standard techniques in incisional hernia repair.

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
Pain/ discomfort during normal activities
Time Frame: 24 months
Pain/ discomfort during normal activities as a result of the hernia or hernia operation 2 years after enrolment measured by the hernia-specific Surgical Pain Scale (SPS) on a 150 mm-scale ranging from "no pain sensation" to "most intense pain imaginable".
24 months

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
Patient satisfaction with care (5 point Likert scale)
Time Frame: 24 months
Patient satisfaction with care is measured by standardized questions by 5 point Likert scale
24 months
Pain/discomfort at rest /pain during sports /maximal pain
Time Frame: 24 months
Pain/ discomfort as a result of hernia / hernia operation; SPS
24 months
Pain Disability Index
Time Frame: 24 months
Limitations of normal activities caused by hernia related pain
24 months
Quality of Life (SF-36)
Time Frame: 24 months
Functional status / quality of life
24 months
Frequency of acute incarcerations
Time Frame: 24 months
Number of acute incacerations in relation to length of watchful waiting
24 months

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.
Charite University, Berlin, Germany

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.
German Research Foundation

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.
  • Principal Investigator: Johannes C Lauscher, M. D., Charité Campus Benjamin Franklin, Berlin, 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.
November 1, 2011

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.
June 1, 2021

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.
June 1, 2021

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).
May 5, 2011

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.
May 5, 2011

First Posted (Estimated)

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.
May 6, 2011

Study Record Updates

Last Update Posted (Estimated)

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.
February 13, 2024

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.
February 10, 2024

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.
February 1, 2024

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.
  • KS6-233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings