Incisional HerniaAWARENCT01349400
Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias
A study testing Watchful waiting and Hernia repair in people with Incisional Hernia, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Watchful waiting and Hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 636 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- asymptomatic/ oligosymptomatic incisional hernia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Incisional Hernia
- Being tested
- Watchful waiting, Hernia repair
- Keywords
- asymptomatic, minimally symptomatic
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watchful waitingOther
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 repairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| watchful waiting | Experimental | 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. Receives: Other: Watchful waiting |
| Hernia repair | Active comparator | 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. Receives: Procedure: Hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 24 months
Secondary outcomes (5)
Patient satisfaction with care (5 point Likert scale)
Patient satisfaction with care is measured by standardized questions by 5 point Likert scale
Measured: 24 months
Pain/discomfort at rest /pain during sports /maximal pain
Pain/ discomfort as a result of hernia / hernia operation; SPS
Measured: 24 months
Pain Disability Index
Limitations of normal activities caused by hernia related pain
Measured: 24 months
Quality of Life (SF-36)
Functional status / quality of life
Measured: 24 months
Frequency of acute incarcerations
Number of acute incacerations in relation to length of watchful waiting
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Watchful waiting vs. surgical repair
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Johannes Lauscher, Charite University, Berlin, Germany
- Investigators
- Johannes C Lauscher, M. D., Principal investigator, Charité Campus Benjamin Franklin, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349400
- Sponsor's protocol ID
- KS6-233
- Acronym
- AWARE
- Status last verified
- Feb 2024
- First submitted
- 5 May 2011
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
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.
PubMed 22314130
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watchful Waiting vs. Repair of Oligosymptomatic Incisional Hernias
- ClinicalTrials.gov ID
- NCT01349400
- Acronym / sponsor ID
- AWARE / KS6-233
- Conditions
- Incisional Hernia
- Keywords
- asymptomatic, minimally symptomatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Nov 2011
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 6 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Watchful waiting vs. surgical repair
| Arm | Type | Receives |
|---|---|---|
| watchful waiting | Experimental | Other: Watchful waitingAfter 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. |
| Hernia repair | Active comparator | Procedure: Hernia repairIntervention: 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥18 years
- asymptomatic/ oligosymptomatic incisional hernia
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watchful waitingWatchful 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. | Other | watchful waiting |
| Hernia repairOpen 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. | Procedure or surgery | Hernia repair |
Primary outcome
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".
5 secondary outcomes
Patient satisfaction with care (5 point Likert scale)
Time frame: 24 months
Pain/discomfort at rest /pain during sports /maximal pain
Time frame: 24 months
Pain Disability Index
Time frame: 24 months
Quality of Life (SF-36)
Time frame: 24 months
Frequency of acute incarcerations
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 22314130Lauscher 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes C Lauscher, M. D. principal investigator
Charité Campus Benjamin Franklin, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watchful waiting and Hernia repair in people with Incisional Hernia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain/ discomfort during normal activities (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01349400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.