Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias (AWARE)

Charité University Medicine Berlin

Status: Completed

Conditions: Incisional Hernia

Treatments: Other: Watchful waiting; Procedure: Hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01349400

KS6-233

Details and patient eligibility

About

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

Full 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.

Enrollment: 636 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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636 participants in 2 patient groups

watchful waiting

Experimental group

Description:

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.

Treatment:

Other: Watchful waiting

Hernia repair

Active Comparator group

Description:

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.

Treatment:

Procedure: Hernia repair