Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
206 participants
INTERVENTIONAL
2018-09-30
2020-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Mini laparotomy
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach
mini laparotomy
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 lumbotomy
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach
mini lumbotomy
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.
Interventions
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mini laparotomy
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 lumbotomy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Abdominal aneurysm or occlusive aortic disease requiring intervention.
* Written consent previously provided by the patient.
* Affiliation to social security.
* Preliminary medical examination.
Exclusion Criteria
* Juxta renal abdominal aortic aneurysm.
* Aneurysmal extension to the iliac arteries.
* Concomitant visceral arteries lesions.
* Urgent surgery.
* Contraindication to surgery.
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Nicla Settembre, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of vascular and endovascular surgery. Nancy University Hospital
Central Contacts
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Other Identifiers
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2016-A00990-51
Identifier Type: -
Identifier Source: org_study_id
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