Prospective Randomized Study of Two Aortic Surgical Approaches: Mini-laparotomy Versus Mini Lumbotomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysms
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 206
- Primary Endpoint
- Intestinal transit recovery
- Last Updated
- 7 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •Hostile abdomen.
- •Juxta renal abdominal aortic aneurysm.
- •Aneurysmal extension to the iliac arteries.
- •Concomitant visceral arteries lesions.
- •Urgent surgery.
- •Contraindication to surgery.
Outcomes
Primary Outcomes
Intestinal transit recovery
Time Frame: day 30
evaluated by reapparition of gas and transit
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
Secondary Outcomes
- Respiratory recovery(day 5)
- Quality of life assessment(after 1 year)
- Renal recovery(day 5)
- Morbi-mortality(day 30)
- Post-operative pain assessment(day 5)
- Intestinal recovery(day 5)