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NCT Number: NCT01349400

Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

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

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Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Campus Benjamin Franklin

Berlin, 12200, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Watchful waiting

Other

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.

Hernia repair

Procedure

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.

Primary outcomes

  1. Pain/ discomfort during normal activities

    Time frame: 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 outcomes

  1. Patient satisfaction with care (5 point Likert scale)

    Time frame: 24 months

    Patient satisfaction with care is measured by standardized questions by 5 point Likert scale

  2. Pain/discomfort at rest /pain during sports /maximal pain

    Time frame: 24 months

    Pain/ discomfort as a result of hernia / hernia operation; SPS

  3. Pain Disability Index

    Time frame: 24 months

    Limitations of normal activities caused by hernia related pain

  4. Quality of Life (SF-36)

    Time frame: 24 months

    Functional status / quality of life

  5. Frequency of acute incarcerations

    Time frame: 24 months

    Number of acute incacerations in relation to length of watchful waiting

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias

Acronym: AWARE

Important dates

Study start
2011
Primary completion
2021
Study completion
2021
First posted
May 6, 2011
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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