Mini-laparotomy Versus Mini Lumbotomy

Not Applicable

• Conditions: Abdominal Aortic Thrombosis; Abdominal Aortic Aneurysms
• Interventions: Procedure: mini lumbotomy; Procedure: mini laparotomy

• Registration Number: NCT02888613
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Status Verified: 2018-09
• Study Start: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-18
• Primary Completion: 2019-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mini lumbotomy	mini lumbotomy	Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach
Mini laparotomy	mini laparotomy	Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach

Primary Outcome Measures

Name	Time	Method
Intestinal transit recovery	day 30	evaluated by reapparition of gas and transit
Respiratory recovery	day 30	evaluated with respiratory function test (Sniff nasal inspiratory pressure, SNIP test)
Renal recovery	day 30	evaluated by blood creatinine level, uremia and kalemia

Secondary Outcome Measures

Name	Time	Method
Respiratory recovery	day 5	evaluated by SNIP test
Quality of life assessment	after 1 year	by using SF-12 questionnaire
Renal recovery	day 5	evaluated by creatinine clearance, uremia and kaliemia
Morbi-mortality	day 30	evaluated by non-recovery of functions, eventration and death
Post-operative pain assessment	day 5	with VAS scale
Intestinal recovery	day 5	assessment of intestinal transit (stool emission)