Abdominal Wall HerniaPhase 4ARTENCT00908193
Laparoscopic "DA VINCI" Robot Assisted Abdominal Wall Hernia Repair
A Phase 4 study testing Laparoscopic DA VINCI Robot Assisted coelioscopy and conventional coelioscopy in people with Abdominal Wall Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias . In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Hernia
- What is being tested?
- Laparoscopic DA VINCI Robot Assisted coelioscopy and conventional coelioscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Jun 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years
- with indication of hernia repair
- a collar with a diameter of less than 10cm
- no antecedent of hernia treatment with poses plate
- agreeing coelioscopy
- agreeing to participate the clinical study, having sign an informed consent
- agreeing a regular monitor
Who cannot join
- taking analgesic tier 2 or 3
- against indication to anesthetics or coelioscopy
- creatinine clearance less than 30 ml/min
- pregnant woman and protected persons
- no affiliation to social security
- unable to understand the information form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia
The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .
In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.
Read the detailed description
Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial:
The main judgement criterion is post operative pain reflected by morphine consumption during the first 48 hours. Secondary criteria are morbidity, quality of life, duration of surgery, conversion rate, complications, the the length of stay and hospital costs.
In this single centre study, inclusion criteria are age above 18, no previous repair of the hernia with a mesh and a diameter of the parietal defect of less than 10 cm. Contraindications are chronic use of pain drugs of level II or above and renal insufficiency (clearance <30ml/min).
The robotic repair was described in a previous paper of our group and will be compared to our classical laparoscopic repair technique, and in both cases with the use of the same prosthetic mesh.
A total of 70 patients to be included in an 18 months period was calculated to prove a 40% reduction in morphine consumption during the postoperative 48h (α=5% and β=10%).
The total duration of the study is 30 months (12 months of follow-up for each patient).
- Conditions
- Abdominal Wall Hernia
- Being tested
- Laparoscopic DA VINCI Robot Assisted coelioscopy, conventional coelioscopy
- Keywords
- Treatment of abdominal ruptured, Digestive system disease, Coelioscopy, Assistance robotics, Medical device, DA VINCI Robot, Pain patient, Morphine consumption, Comparative Randomized study, patient over 18 years, with ruptured abdominal, with an indication of treatment of ruptured
- Medical subject headings
- Hernia, Abdominal, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic DA VINCI Robot Assisted coelioscopyDevice
Also called Laparoscopic DA VINCI Robot Assisted abdominal coelioscopy
Patients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate
conventional coelioscopyProcedure or surgery
Patients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | robot-assisted coelioscopy Receives: Device: Laparoscopic DA VINCI Robot Assisted coelioscopy |
| 2 | Active comparator | conventional coelioscopy Receives: Procedure: conventional coelioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the reduction in morphine consumption
Measured: during the postoperative 48h
Secondary outcomes (5)
Pain patient (ENS, total consumption of morphine)
Measured: during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery
quality of life (questionary SF-36)
Measured: 1 month, 6 month and 12 month of surgery
length of stay in hospital, percentage return home to 24 hours of surgery
Measured: to 24 hours of surgery
morbidity
Measured: during the study
resumption of work
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2009 (estimated)
- Study startJul 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall HerniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Tayar, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908193
- Sponsor's protocol ID
- P051080
- Acronym
- ARTE
- Status last verified
- Jul 2013
- First submitted
- 22 May 2009
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia
- ClinicalTrials.gov ID
- NCT00908193
- Acronym / sponsor ID
- ARTE / P051080
- Conditions
- Abdominal Wall Hernia
- Keywords
- Treatment of abdominal ruptured, Digestive system disease, Coelioscopy, Assistance robotics, Medical device, DA VINCI Robot, Pain patient, Morphine consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 May 2009 (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 aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .
In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.
Detailed description
Laparoscopic Robot Assisted abdominal wall hernia repair : a prospective randomized trial:
The main judgement criterion is post operative pain reflected by morphine consumption during the first 48 hours. Secondary criteria are morbidity, quality of life, duration of surgery, conversion rate, complications, the the length of stay and hospital costs.
In this single centre study, inclusion criteria are age above 18, no previous repair of the hernia with a mesh and a diameter of the parietal defect of less than 10 cm. Contraindications are chronic use of pain drugs of level II or above and renal insufficiency (clearance <30ml/min).
The robotic repair was described in a previous paper of our group and will be compared to our classical laparoscopic repair technique, and in both cases with the use of the same prosthetic mesh.
A total of 70 patients to be included in an 18 months period was calculated to prove a 40% reduction in morphine consumption during the postoperative 48h (α=5% and β=10%).
The total duration of the study is 30 months (12 months of follow-up for each patient).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Laparoscopic DA VINCI Robot Assisted coelioscopyrobot-assisted coelioscopy |
| 2 | Active comparator | Procedure: conventional coelioscopyconventional coelioscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- over 18 years
- with indication of hernia repair
- a collar with a diameter of less than 10cm
- no antecedent of hernia treatment with poses plate
- agreeing coelioscopy
Key exclusion criteria (6 listed)
- taking analgesic tier 2 or 3
- against indication to anesthetics or coelioscopy
- creatinine clearance less than 30 ml/min
- pregnant woman and protected persons
- no affiliation to social security
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 |
|---|---|---|
| Laparoscopic DA VINCI Robot Assisted coelioscopyAlso: Laparoscopic DA VINCI Robot Assisted abdominal coelioscopyPatients with abdominal wall hernia will be treated by robot-assisted coelioscopy for the poses of abdominal plate | Device | 1 |
| conventional coelioscopyPatients with abdominal wall hernia will be treated by conventional coelioscopy for the poses of abdominal plate | Procedure or surgery | 2 |
Primary outcome
Evaluate the reduction in morphine consumption
Time frame: during the postoperative 48h
5 secondary outcomes
Pain patient (ENS, total consumption of morphine)
Time frame: during the hospitalization, to 10 days,1 month, 6 months and 12 months of surgery
quality of life (questionary SF-36)
Time frame: 1 month, 6 month and 12 month of surgery
length of stay in hospital, percentage return home to 24 hours of surgery
Time frame: to 24 hours of surgery
morbidity
Time frame: during the study
resumption of work
Time frame: after surgery
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 2 Aug 2013.
Related trials for Abdominal Wall Hernia
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Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
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Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
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Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
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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.
Claude Tayar principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic DA VINCI Robot Assisted coelioscopy and conventional coelioscopy in people with Abdominal Wall Hernia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 6 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 2 Aug 2013. 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Evaluate the reduction in morphine consumption (time frame: during the postoperative 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2013.