Postoperative ComplicationsNCT00478348
Should Prosthetic Repair of Incisional Abdominal Hernias be Drain or Not?
A study testing Prosthetic repair of abdominal incisional hernia in people with Postoperative Complications and Hernia, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Postoperative Complications, Hernia
- What is being tested?
- Prosthetic repair of abdominal incisional hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to 10 Nov 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of midline abdominal wall incisional hernia
- Adults of 20 to 80 years old
- ASA I to III
- Inform consent signed by the patient and investigators
Who cannot join
- Incisional hernia less than 2 cm
- Groin hernia
- Antibiotic treatment before and during hospital admission
- Emergency admission for strangulated incisional hernia
- Immunosuppressing treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery, University Hospital Center
Lausanne, Canton of Vaud, 1011
About this study
Official title: Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.
The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.
Read the detailed description
Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.
Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.
Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.
In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.
The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.
- Conditions
- Postoperative Complications, Hernia
- Being tested
- Prosthetic repair of abdominal incisional hernia
- Keywords
- Postoperative Complications, Drainage, Infection, Seroma, Hematoma, Recurrence, Abdominal Wall, Hernia, Surgical Mesh
- Medical subject headings
- Postoperative Complications, Hernia, Infections, Seroma, Hematoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic repair of abdominal incisional herniaProcedure or surgery
Rives-Stoppa repair of incisional hernia
| Study group | Role | What they receive |
|---|---|---|
| Drain | Other | Not described Receives: Procedure: Prosthetic repair of abdominal incisional hernia |
| No drain | Other | Not described Receives: Procedure: Prosthetic repair of abdominal incisional hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startMay 2007
- Primary completion1 Oct 2017
- Study completion10 Nov 2017
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 Postoperative ComplicationsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Nicolas Demartines, MD, Study chair, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478348
- Sponsor's protocol ID
- DP-2007-CHV-UNIL
- Status last verified
- Nov 2017
- First submitted
- 22 May 2007
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Willemin M, Schaffer C, Kefleyesus A, Dayer A, Demartines N, Schafer M, Allemann P. Drain Versus No Drain in Open Mesh Repair for Incisional Hernia, Results of a Prospective Randomized Controlled Trial. World J Surg. 2023 Feb;47(2):461-468. doi: 10.1007/s00268-022-06725-4. Epub 2022 Dec 15.
PubMed 36520177
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy of Drainage During Prosthetic Repair of Incisional Abdominal Hernias: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00478348
- Acronym / sponsor ID
- DP-2007-CHV-UNIL
- Conditions
- Postoperative Complications, Hernia
- Keywords
- Postoperative Complications, Drainage, Infection, Seroma, Hematoma, Recurrence, Abdominal Wall, Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- May 2007 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 24 May 2007 (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.
The purpose of this study is to determine whether drainage after prosthetic repair of incisional abdominal hernias increases or decreases complications such as infection, seromas and hematomas.
Detailed description
Between 3 to 20% of patients who received a midline laparotomy will develop an incisional hernia.
Primary suture of the defect is associated with a recurrence rate between 25 and 50%.Mesh repair is superior with regard to the recurrence (12-20%), but early postoperative complications include infections, hematomas and seromas.
Some advocate the use of drains in order to diminish secretions and complications. Other claim that drains increase the complication's rate.
In the absence of a randomized controlled trial it's not clear whether drainage could influence positively or negatively the occurence of such complications when performing a prosthetic repair of abdominal incisional hernia.
The aim of this study is to answer this question, comparing prospectively two groups of operated patients: the former with drainage and the latter without.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain | Other | Procedure: Prosthetic repair of abdominal incisional hernia |
| No drain | Other | Procedure: Prosthetic repair of abdominal incisional hernia |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of midline abdominal wall incisional hernia
- Adults of 20 to 80 years old
- ASA I to III
- Inform consent signed by the patient and investigators
Key exclusion criteria (5 listed)
- Incisional hernia less than 2 cm
- Groin hernia
- Antibiotic treatment before and during hospital admission
- Emergency admission for strangulated incisional hernia
- Immunosuppressing treatment
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 |
|---|---|---|
| Prosthetic repair of abdominal incisional herniaRives-Stoppa repair of incisional hernia | Procedure or surgery | Drain, No drain |
Primary outcome
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings.
Time frame: 30 days
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 17 Nov 2017.
- Derived from this study: PubMed 36520177Willemin M, Schaffer C, Kefleyesus A, Dayer A, Demartines N, Schafer M, Allemann P. Drain Versus No Drain in Open Mesh Repair for Incisional Hernia, Results of a Prospective Randomized Controlled Trial. World J Surg. 2023 Feb;47(2):461-468. doi: 10.1007/s00268-022-06725-4. Epub 2022 Dec 15.
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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.
Nicolas Demartines, MD study chair
Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic repair of abdominal incisional hernia in people with Postoperative Complications and Hernia, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 4 inclusion and 5 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 17 Nov 2017. 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 Switzerland. 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?
Evidence of early clinical infection, hematoma, seroma or recurrence confirmed by ultrasonography or/and laboratory findings. (time frame: 30 days). 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 NCT00478348, 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 17 Nov 2017.