Mini-laparotomy Versus Mini Lumbotomy

Abdominal Aortic Aneurysms Clinical Trial

— RAMini  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02888613
• Other study ID #: 2016-A00990-51
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: January 2020

Study information

• Verified date: September 2018
• Source: Central Hospital, Nancy, France
• Contact: Nicla Settembre, MD, PhD
• Phone: +33(0)383154384
• Email: n.settembre[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysms
• Abdominal Aortic Thrombosis
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Thrombosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory recovery	evaluated with respiratory function test (Sniff nasal inspiratory pressure, SNIP test)	day 30
Primary	Renal recovery	evaluated by blood creatinine level, uremia and kalemia	day 30
Primary	Intestinal transit recovery	evaluated by reapparition of gas and transit	day 30
Secondary	Respiratory recovery	evaluated by SNIP test	day 1
Secondary	Respiratory recovery	evaluated by SNIP test	day 3
Secondary	Respiratory recovery	evaluated by SNIP test	day 5
Secondary	Renal recovery	evaluated by creatinine clearance, uremia and kaliemia	day 1
Secondary	Renal recovery	evaluated by creatinine clearance, uremia and kaliemia	day 3
Secondary	Renal recovery	evaluated by creatinine clearance, uremia and kaliemia	day 5
Secondary	Intestinal recovery	assessment of intestinal transit (stool emission)	day 1
Secondary	Intestinal recovery	assessment of intestinal transit (stool emission)	day 3
Secondary	Intestinal recovery	assessment of intestinal transit (stool emission)	day 5
Secondary	Post-operative pain assessment	with VAS scale	day 1
Secondary	Post-operative pain assessment	with VAS scale	day 3
Secondary	Post-operative pain assessment	with VAS scale	day 5
Secondary	Quality of life assessment	by using SF-12 questionnaire	after 6 months
Secondary	Quality of life assessment	by using SF-12 questionnaire	after 1 year
Secondary	Morbi-mortality	evaluated by EQ-5D questionnaire	after 6 months
Secondary	Morbi-mortality	evaluated by EQ-5D questionnaire	after 1 year
Secondary	Morbi-mortality	evaluated by non-recovery of functions, eventration and death	day 30