Clinical trial NCT01349400: Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias
Official title: Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Keywords: asymptomatic
minimally symptomatic
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2011-05-06
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Watchful waiting vs. surgical repair
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain/ discomfort during normal activities
timeFrame: 24 months
Secondary outcomes:
measure: Patient satisfaction with care (5 point Likert scale)
timeFrame: 24 months
measure: Pain/discomfort at rest /pain during sports /maximal pain
timeFrame: 24 months
measure: Pain Disability Index
timeFrame: 24 months
measure: Quality of Life (SF-36)
timeFrame: 24 months
measure: Frequency of acute incarcerations
timeFrame: 24 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
Study officials:
affiliation: Charité Campus Benjamin Franklin, Berlin, Germany
name: Johannes C Lauscher, M. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauscher JC, Martus P, Stroux A, Neudecker J, Behrens U, Hammerich R, Buhr HJ, Ritz JP. Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial. Trials. 2012 Feb 7;13:14. doi: 10.1186/1745-6215-13-14.