Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias (AWARE)
Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities.
Other: Watchful waiting
Procedure: Hernia repair
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias|
- Pain/ discomfort during normal activities [ Time Frame: 24 months ] [ Designated as safety issue: No ]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".
- Costs of treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Patient satisfaction with care is measured by standardized questions by 5 point Likert scale
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349400
|Contact: Johannes C Lauscher, M. D.||0049 30 8445 ext firstname.lastname@example.org|
|Charité Campus Benjamin Franklin||Recruiting|
|Berlin, Germany, 12200|
|Contact: Johannes C Lauscher, M. D. 0049 30 8445 ext 2542 email@example.com|
|Principal Investigator: Johannes C Lauscher, M. D.|
|Principal Investigator:||Johannes C Lauscher, M. D.||Charité Campus Benjamin Franklin, Berlin, Germany|