Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias
Condition: Incisional Hernia
MeSH terms: Hernia; Incisional Hernia
Study type: Interventional

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 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.
    

Intervention name(s): Watchful waiting; Hernia repair
Intervention type(s): Other; Procedure
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Watchful waiting vs. surgical repair
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: asymptomatic; minimally symptomatic