Clinical Trial: Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias

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

Detailed Summary: 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.
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: 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".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: May 5, 2011
Date Started: November 2011
Date Completion: May 2019
Last Updated: August 14, 2015
Last Verified: August 2015