Clinical trial NCT02888613: Mini-laparotomy Versus Mini Lumbotomy
Official title: Prospective Randomized Study of Two Aortic Surgical Approaches: Mini-laparotomy Versus Mini Lumbotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurysms
Abdominal Aortic Thrombosis
Keywords: mini-lumbotomy
mini-laparotomy
retroperitoneal approach
transperitoneal approach
abdominal aortic surgery
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Respiratory recovery
timeFrame: day 30
measure: Renal recovery
timeFrame: day 30
measure: Intestinal transit recovery
timeFrame: day 30
Secondary outcomes:
measure: Respiratory recovery
timeFrame: day 1
measure: Respiratory recovery
timeFrame: day 3
measure: Respiratory recovery
timeFrame: day 5
measure: Renal recovery
timeFrame: day 1
measure: Renal recovery
timeFrame: day 3
measure: Renal recovery
timeFrame: day 5
measure: Intestinal recovery
timeFrame: day 1
measure: Intestinal recovery
timeFrame: day 3
measure: Intestinal recovery
timeFrame: day 5
measure: Post-operative pain assessment
timeFrame: day 1
measure: Post-operative pain assessment
timeFrame: day 3
measure: Post-operative pain assessment
timeFrame: day 5
measure: Quality of life assessment
timeFrame: after 6 months
measure: Quality of life assessment
timeFrame: after 1 year
measure: Morbi-mortality
timeFrame: after 6 months
measure: Morbi-mortality
timeFrame: after 1 year
measure: Morbi-mortality
timeFrame: day 30
Other outcomes:
Locations:
Study officials:
affiliation: Department of vascular and endovascular surgery. Nancy University Hospital
name: Nicla Settembre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: