Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias (AWARE)

Watchful Waiting vs. 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.

Study Overview

• Status: Completed
• Conditions: Incisional Hernia
• Intervention / Treatment: Other: Watchful waiting; Procedure: Hernia repair

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.

• Study Type: Interventional
• Enrollment (Actual): 636
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12200
    • Charite Campus Benjamin Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: watchful waiting; After informed consent and randomization into the watchful waiting group patients will receive standardized verbal information and written instructions on symptoms of acute incarceration. In case of acute symptoms they will be told to visit a physician immediately. On follow-up visits at 1 month, 12 months and 24 months the hernia size will be determined by physical examination, and the pain/ discomfort and the functional status will be monitored. Control intervention/ reference test: 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. Divergent types of repair are permitted but have to be documented.	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.
Active Comparator: Hernia repair; Intervention: 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. Divergent types of repair are permitted but have to be documented.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: German Research Foundation
• Investigators: Principal Investigator: Johannes C Lauscher, M. D., Charité Campus Benjamin Franklin, Berlin, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: May 5, 2011
• First Submitted That Met QC Criteria: May 5, 2011
• First Posted (Estimated): May 6, 2011

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: asymptomatic; minimally symptomatic
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: KS6-233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP