Mini-laparotomy Versus Mini Lumbotomy (RAMini)

Prospective Randomized Study of Two Aortic Surgical Approaches: Mini-laparotomy Versus Mini Lumbotomy

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Aortic Aneurysms; Abdominal Aortic Thrombosis
• Intervention / Treatment: Procedure: mini laparotomy; Procedure: mini lumbotomy

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 Type: Interventional
• Enrollment (Anticipated): 206
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicla Settembre, MD, PhD; Phone Number: +33(0)383154384; Email: n.settembre@chru-nancy.fr
• Study Contact Backup: Name: Sergueï Malikov, MD, PhD; Phone Number: +33(0)383153860; Email: s.malikov@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mini laparotomy; Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach	Procedure: 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.; Other Names: transperitoneal approach
Other: Mini lumbotomy; Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach	Procedure: 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 Names: retro-peritoneal approach

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory recovery	evaluated by SNIP test	day 1
Respiratory recovery	evaluated by SNIP test	day 3
Respiratory recovery	evaluated by SNIP test	day 5
Renal recovery	evaluated by creatinine clearance, uremia and kaliemia	day 1
Renal recovery	evaluated by creatinine clearance, uremia and kaliemia	day 3
Renal recovery	evaluated by creatinine clearance, uremia and kaliemia	day 5
Intestinal recovery	assessment of intestinal transit (stool emission)	day 1
Intestinal recovery	assessment of intestinal transit (stool emission)	day 3
Intestinal recovery	assessment of intestinal transit (stool emission)	day 5
Post-operative pain assessment	with VAS scale	day 1
Post-operative pain assessment	with VAS scale	day 3
Post-operative pain assessment	with VAS scale	day 5
Quality of life assessment	by using SF-12 questionnaire	after 6 months
Quality of life assessment	by using SF-12 questionnaire	after 1 year
Morbi-mortality	evaluated by EQ-5D questionnaire	after 6 months
Morbi-mortality	evaluated by EQ-5D questionnaire	after 1 year
Morbi-mortality	evaluated by non-recovery of functions, eventration and death	day 30

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Nicla Settembre, MD, PhD, Department of vascular and endovascular surgery. Nancy University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: mini-lumbotomy; mini-laparotomy; retroperitoneal approach; transperitoneal approach; abdominal aortic surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Aortic Diseases; Thrombosis; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2016-A00990-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No