Mini-laparotomy Versus Mini Lumbotomy (RAMini)

Central Hospital, Nancy, France

Status: Unknown

Conditions: Abdominal Aortic Thrombosis; Abdominal Aortic Aneurysms

Treatments: Procedure: mini lumbotomy; Procedure: mini laparotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02888613

2016-A00990-51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Mini laparotomy

Other group

Description:

Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach

Treatment:

Procedure: mini laparotomy

Mini lumbotomy

Other group

Description:

Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach

Treatment:

Procedure: mini lumbotomy