Abdominal Aortic AneurysmsRAMiniNCT02888613
Mini-laparotomy Versus Mini Lumbotomy
A study testing mini laparotomy and mini lumbotomy in people with Abdominal Aortic Aneurysms and Abdominal Aortic Thrombosis, run by Central Hospital, Nancy, France.
Trial summary
This study aims to compare the results of two mini invasive surgical approaches in abdominal aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit will be assessed after 30 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms, Abdominal Aortic Thrombosis
- What is being tested?
- mini laparotomy and mini lumbotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective abdominal aortic repair.
- Abdominal aneurysm or occlusive aortic disease requiring intervention.
- Written consent previously provided by the patient.
- Affiliation to social security.
- Preliminary medical examination.
Who cannot join
- Hostile abdomen.
- Juxta renal abdominal aortic aneurysm.
- Aneurysmal extension to the iliac arteries.
- Concomitant visceral arteries lesions.
- Urgent surgery.
- Contraindication to surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Randomized Study of Two Aortic Surgical Approaches: Mini-laparotomy Versus Mini Lumbotomy
This study aims to compare the results of two mini invasive surgical approaches in abdominal aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit will be assessed after 30 days.
The secondary purpose of this study is to assess the life quality and morbi-mortality at 30 days, as well as at 6 and 12 months.
Read the detailed description
Following abdominal aortic surgery, post-operative outcomes are considered favorable with a rapid recovery of respiratory, renal functions and intestinal transit, with limited cardiac events. Complications are still frequent after the classic open abdominal surgery.
In abdominal aortic surgery, "mini" abdominal incision has been proposed as an alternative to the classic large surgical approach.
Two mini surgical approaches are possible: mini lumbotomy with retroperitoneal approach, and mini laparatomy with transperitoneal approach.
Previous studies have only compared classic versus mini surgical approaches and many are retrospectives studies. Pain control through the mini-incision surgery allowed early mobilization of patients, improved lung function, reduced muscle loss, and favoured intestinal motility.
So far, no study has compared the results of two mini invasive aortic approaches.
The aim of this prospective randomized study is to compare two mini-invasive surgical approaches and to determine which of them allows the improvement of surgical outcomes with less morbi-mortality.
- Being tested
- mini laparotomy, mini lumbotomy
- Keywords
- mini-lumbotomy, mini-laparotomy, retroperitoneal approach, transperitoneal approach, abdominal aortic surgery
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini laparotomyProcedure or surgery
Also called transperitoneal approach
The patient will be positioned supine. After induction of general anesthesia, a median umbilical incision will be performed. The average length of the incision of the laparotomy will be 10 cm (8-12 cm). The small intestine will be then mobilized medially and held by an orthostatic retractor. Arterial dissection and control as well as bypasses will be performed according to the conventional technique. In case of occlusive disease of the iliac arteries, femoral site will be selected to achieve the distal anastomoses of the bifurcated prosthetic graft.
mini lumbotomyProcedure or surgery
Also called retro-peritoneal approach
After induction of general anesthesia, the patient will be positioned in right lateral decubitus at 45° of the table plane. The incision will be performed from the tip of the eleventh rib with a slightly sloping path to the outer edge of the rectus muscle. The average length of the incision of the laparotomy will be 10 cm (8-12 cm).
Abdominal aorta will be approached retroperitoneally. Arterial dissection and control as well as bypasses will be performed according to the conventional retroperitoneal technique. In case of occlusive disease of the iliac arteries, femoral site will be selected to achieve the distal anastomoses of the bifurcated prosthetic graft.
| Study group | Role | What they receive |
|---|---|---|
| Mini laparotomy | Other | Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach Receives: Procedure: mini laparotomy |
| Mini lumbotomy | Other | Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach Receives: Procedure: mini lumbotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory recovery
evaluated with respiratory function test (Sniff nasal inspiratory pressure, SNIP test)
Measured: day 30
Renal recovery
evaluated by blood creatinine level, uremia and kalemia
Measured: day 30
Intestinal transit recovery
evaluated by reapparition of gas and transit
Measured: day 30
Secondary outcomes (17)
Respiratory recovery
evaluated by SNIP test
Measured: day 1
Respiratory recovery
evaluated by SNIP test
Measured: day 3
Respiratory recovery
evaluated by SNIP test
Measured: day 5
Renal recovery
evaluated by creatinine clearance, uremia and kaliemia
Measured: day 1
Renal recovery
evaluated by creatinine clearance, uremia and kaliemia
Measured: day 3
Renal recovery
evaluated by creatinine clearance, uremia and kaliemia
Measured: day 5
Intestinal recovery
assessment of intestinal transit (stool emission)
Measured: day 1
Intestinal recovery
assessment of intestinal transit (stool emission)
Measured: day 3
Intestinal recovery
assessment of intestinal transit (stool emission)
Measured: day 5
Post-operative pain assessment
with VAS scale
Measured: day 1
Post-operative pain assessment
with VAS scale
Measured: day 3
Post-operative pain assessment
with VAS scale
Measured: day 5
Quality of life assessment
by using SF-12 questionnaire
Measured: after 6 months
Quality of life assessment
by using SF-12 questionnaire
Measured: after 1 year
Morbi-mortality
evaluated by EQ-5D questionnaire
Measured: after 6 months
Morbi-mortality
evaluated by EQ-5D questionnaire
Measured: after 1 year
Morbi-mortality
evaluated by non-recovery of functions, eventration and death
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startSep 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicla Settembre, MD, PhD, Principal investigator, Department of vascular and endovascular surgery. Nancy University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888613
- Sponsor's protocol ID
- 2016-A00990-51
- Acronym
- RAMini
- Status last verified
- Sep 2018
- First submitted
- 1 Jul 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of Two Aortic Surgical Approaches: Mini-laparotomy Versus Mini Lumbotomy
- ClinicalTrials.gov ID
- NCT02888613
- Acronym / sponsor ID
- RAMini / 2016-A00990-51
- Keywords
- mini-lumbotomy, mini-laparotomy, retroperitoneal approach, transperitoneal approach, abdominal aortic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 5 Sep 2016 (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.
This study aims to compare the results of two mini invasive surgical approaches in abdominal aortic surgery: mini lumbotomy with retroperitoneal approach versus mini laparotomy with transperitoneal approach. Respiratory and renal functions and recovery of intestinal transit will be assessed after 30 days.
The secondary purpose of this study is to assess the life quality and morbi-mortality at 30 days, as well as at 6 and 12 months.
Detailed description
Following abdominal aortic surgery, post-operative outcomes are considered favorable with a rapid recovery of respiratory, renal functions and intestinal transit, with limited cardiac events. Complications are still frequent after the classic open abdominal surgery.
In abdominal aortic surgery, "mini" abdominal incision has been proposed as an alternative to the classic large surgical approach.
Two mini surgical approaches are possible: mini lumbotomy with retroperitoneal approach, and mini laparatomy with transperitoneal approach.
Previous studies have only compared classic versus mini surgical approaches and many are retrospectives studies. Pain control through the mini-incision surgery allowed early mobilization of patients, improved lung function, reduced muscle loss, and favoured intestinal motility.
So far, no study has compared the results of two mini invasive aortic approaches.
The aim of this prospective randomized study is to compare two mini-invasive surgical approaches and to determine which of them allows the improvement of surgical outcomes with less morbi-mortality.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini laparotomy | Other | Procedure: mini laparotomyPatients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach |
| Mini lumbotomy | Other | Procedure: mini lumbotomyPatients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective abdominal aortic repair.
- Abdominal aneurysm or occlusive aortic disease requiring intervention.
- Written consent previously provided by the patient.
- Affiliation to social security.
- Preliminary medical examination.
Key exclusion criteria (6 listed)
- Hostile abdomen.
- Juxta renal abdominal aortic aneurysm.
- Aneurysmal extension to the iliac arteries.
- Concomitant visceral arteries lesions.
- Urgent surgery.
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 |
|---|---|---|
| mini laparotomyAlso: transperitoneal approachThe patient will be positioned supine. After induction of general anesthesia, a median umbilical incision will be performed. The average length of the incision of the laparotomy will be 10 cm (8-12 cm). The small intestine will be then mobilized medially and held by an orthostatic retractor. Arterial dissection and control as well as bypasses will be performed according to the conventional technique. In case of occlusive disease of the iliac arteries, femoral site will be selected to achieve the distal anastomoses of the bifurcated prosthetic graft. | Procedure or surgery | Mini laparotomy |
| mini lumbotomyAlso: retro-peritoneal approachAfter induction of general anesthesia, the patient will be positioned in right lateral decubitus at 45° of the table plane. The incision will be performed from the tip of the eleventh rib with a slightly sloping path to the outer edge of the rectus muscle. The average length of the incision of the laparotomy will be 10 cm (8-12 cm). Abdominal aorta will be approached retroperitoneally. Arterial dissection and control as well as bypasses will be performed according to the conventional retroperitoneal technique. In case of occlusive disease of the iliac arteries, femoral site will be selected to achieve the distal anastomoses of the bifurcated prosthetic graft. | Procedure or surgery | Mini lumbotomy |
Primary outcome
Respiratory recovery
Time frame: day 30
evaluated with respiratory function test (Sniff nasal inspiratory pressure, SNIP test)
Renal recovery
Time frame: day 30
evaluated by blood creatinine level, uremia and kalemia
Intestinal transit recovery
Time frame: day 30
evaluated by reapparition of gas and transit
17 secondary outcomes
Respiratory recovery
Time frame: day 1
Respiratory recovery
Time frame: day 3
Respiratory recovery
Time frame: day 5
Renal recovery
Time frame: day 1
Renal recovery
Time frame: day 3
Renal recovery
Time frame: day 5
Intestinal recovery
Time frame: day 1
Intestinal recovery
Time frame: day 3
Intestinal recovery
Time frame: day 5
Post-operative pain assessment
Time frame: day 1
Post-operative pain assessment
Time frame: day 3
Post-operative pain assessment
Time frame: day 5
Quality of life assessment
Time frame: after 6 months
Quality of life assessment
Time frame: after 1 year
Morbi-mortality
Time frame: after 6 months
Morbi-mortality
Time frame: after 1 year
Morbi-mortality
Time frame: day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Abdominal Aortic Aneurysms
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
AneuFix - Prophylactic Sac Filling
Abdominal Aortic Aneurysm, Endoleak
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak
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.
Nicla Settembre, MD, PhD principal investigator
Department of vascular and endovascular surgery. Nancy University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing mini laparotomy and mini lumbotomy in people with Abdominal Aortic Aneurysms and Abdominal Aortic Thrombosis, run by Central Hospital, Nancy, 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 5 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: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicla Settembre, MD, PhD (+33(0)383154384, n.settembre@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory recovery (time frame: day 30). The study lists 3 primary outcomes in all. 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 18 Sep 2018.