Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

Incisional Hernia Clinical Trial

— AWARE  

Official title:

Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01349400
• Other study ID #: KS6-233
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: June 2021

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Other:
• Watchful 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.

Procedure:
• Hernia 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.

Locations

Country	Name	City	State
Germany	Charité Campus Benjamin Franklin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain/ discomfort during normal activities	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".	24 months
Secondary	Patient satisfaction with care (5 point Likert scale)	Patient satisfaction with care is measured by standardized questions by 5 point Likert scale	24 months
Secondary	Pain/discomfort at rest /pain during sports /maximal pain	Pain/ discomfort as a result of hernia / hernia operation; SPS	24 months
Secondary	Pain Disability Index	Limitations of normal activities caused by hernia related pain	24 months
Secondary	Quality of Life (SF-36)	Functional status / quality of life	24 months
Secondary	Frequency of acute incarcerations	Number of acute incacerations in relation to length of watchful waiting	24 months