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Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias (AWARE)

This study is currently recruiting participants.
Verified December 2011 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Johannes Lauscher, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01349400
First received: May 5, 2011
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Incisional Hernia
 Other: Watchful waiting
Procedure: Hernia repair
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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".


Secondary Outcome Measures:
  • Costs of treatment [ Time Frame: 24 months ]
    Costs of tretament: direct costs(utilization of medical resources, purchase of drugs, costs of the operation, hospital stay) indirect costs: time off from work

  • 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


Estimated Enrollment: 636
Study Start Date: November 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 aim is to determine pain and discomfort, quality of life, patient satisfaction, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349400

Contacts
Contact: Johannes C Lauscher, M. D. 0049 30 8445 ext 2542 johannes.lauscher@charite.de

Locations
Germany
Charité Campus Benjamin Franklin Recruiting
Berlin, Germany, 12200
Contact: Johannes C Lauscher, M. D.     0049 30 8445 ext 2542     johannes.lauscher@charite.de    
Principal Investigator: Johannes C Lauscher, M. D.            
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Investigators
Principal Investigator: Johannes C Lauscher, M. D. Charité Campus Benjamin Franklin, Berlin, Germany
  More Information

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johannes Lauscher, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01349400     History of Changes
Other Study ID Numbers: KS6-233
Study First Received: May 5, 2011
Last Updated: December 6, 2011
Health Authority: Ethics committee, Charité Berlin, Germany `:`

Keywords provided by Charite University, Berlin, Germany:
asymptomatic
minimally symptomatic

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013