Incisional Hernia
Conditions
Keywords
asymptomatic, minimally symptomatic
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 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.
Interventions
OTHERWatchful 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.
PROCEDUREHernia 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.
Sponsors
German Research Foundation
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Watchful waiting vs. surgical repair
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain/ discomfort during normal activities | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with care (5 point Likert scale) | 24 months | Patient satisfaction with care is measured by standardized questions by 5 point Likert scale |
| Pain/discomfort at rest /pain during sports /maximal pain | 24 months | Pain/ discomfort as a result of hernia / hernia operation; SPS |
| Pain Disability Index | 24 months | Limitations of normal activities caused by hernia related pain |
| Quality of Life (SF-36) | 24 months | Functional status / quality of life |
| Frequency of acute incarcerations | 24 months | Number of acute incacerations in relation to length of watchful waiting |
Countries
Germany
Outcome results
None listed