Mini-laparotomy Versus Mini Lumbotomy (RAMini)
Primary Purpose
Abdominal Aortic Aneurysms, Abdominal Aortic Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mini laparotomy
mini lumbotomy
Sponsored by
About this trial
This is an interventional other trial for Abdominal Aortic Aneurysms focused on measuring mini-lumbotomy, mini-laparotomy, retroperitoneal approach, transperitoneal approach, abdominal aortic surgery
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Mini laparotomy
Mini lumbotomy
Arm Description
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach
Outcomes
Primary Outcome Measures
Respiratory recovery
evaluated with respiratory function test (Sniff nasal inspiratory pressure, SNIP test)
Renal recovery
evaluated by blood creatinine level, uremia and kalemia
Intestinal transit recovery
evaluated by reapparition of gas and transit
Secondary Outcome Measures
Respiratory recovery
evaluated by SNIP test
Respiratory recovery
evaluated by SNIP test
Respiratory recovery
evaluated by SNIP test
Renal recovery
evaluated by creatinine clearance, uremia and kaliemia
Renal recovery
evaluated by creatinine clearance, uremia and kaliemia
Renal recovery
evaluated by creatinine clearance, uremia and kaliemia
Intestinal recovery
assessment of intestinal transit (stool emission)
Intestinal recovery
assessment of intestinal transit (stool emission)
Intestinal recovery
assessment of intestinal transit (stool emission)
Post-operative pain assessment
with VAS scale
Post-operative pain assessment
with VAS scale
Post-operative pain assessment
with VAS scale
Quality of life assessment
by using SF-12 questionnaire
Quality of life assessment
by using SF-12 questionnaire
Morbi-mortality
evaluated by EQ-5D questionnaire
Morbi-mortality
evaluated by EQ-5D questionnaire
Morbi-mortality
evaluated by non-recovery of functions, eventration and death
Full Information
NCT ID
NCT02888613
First Posted
July 1, 2016
Last Updated
September 17, 2018
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT02888613
Brief Title
Mini-laparotomy Versus Mini Lumbotomy
Acronym
RAMini
Official Title
Prospective Randomized Study of Two Aortic Surgical Approaches: Mini-laparotomy Versus Mini Lumbotomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysms, Abdominal Aortic Thrombosis
Keywords
mini-lumbotomy, mini-laparotomy, retroperitoneal approach, transperitoneal approach, abdominal aortic surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mini laparotomy
Arm Type
Other
Arm Description
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with transperitoneal approach
Arm Title
Mini lumbotomy
Arm Type
Other
Arm Description
Patients with surgical indication to mini invasive aortic repair will be operated after randomisation with retroperitoneal approach
Intervention Type
Procedure
Intervention Name(s)
mini laparotomy
Other Intervention Name(s)
transperitoneal approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
mini lumbotomy
Other Intervention Name(s)
retro-peritoneal approach
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory recovery
Description
evaluated with respiratory function test (Sniff nasal inspiratory pressure, SNIP test)
Time Frame
day 30
Title
Renal recovery
Description
evaluated by blood creatinine level, uremia and kalemia
Time Frame
day 30
Title
Intestinal transit recovery
Description
evaluated by reapparition of gas and transit
Time Frame
day 30
Secondary Outcome Measure Information:
Title
Respiratory recovery
Description
evaluated by SNIP test
Time Frame
day 1
Title
Respiratory recovery
Description
evaluated by SNIP test
Time Frame
day 3
Title
Respiratory recovery
Description
evaluated by SNIP test
Time Frame
day 5
Title
Renal recovery
Description
evaluated by creatinine clearance, uremia and kaliemia
Time Frame
day 1
Title
Renal recovery
Description
evaluated by creatinine clearance, uremia and kaliemia
Time Frame
day 3
Title
Renal recovery
Description
evaluated by creatinine clearance, uremia and kaliemia
Time Frame
day 5
Title
Intestinal recovery
Description
assessment of intestinal transit (stool emission)
Time Frame
day 1
Title
Intestinal recovery
Description
assessment of intestinal transit (stool emission)
Time Frame
day 3
Title
Intestinal recovery
Description
assessment of intestinal transit (stool emission)
Time Frame
day 5
Title
Post-operative pain assessment
Description
with VAS scale
Time Frame
day 1
Title
Post-operative pain assessment
Description
with VAS scale
Time Frame
day 3
Title
Post-operative pain assessment
Description
with VAS scale
Time Frame
day 5
Title
Quality of life assessment
Description
by using SF-12 questionnaire
Time Frame
after 6 months
Title
Quality of life assessment
Description
by using SF-12 questionnaire
Time Frame
after 1 year
Title
Morbi-mortality
Description
evaluated by EQ-5D questionnaire
Time Frame
after 6 months
Title
Morbi-mortality
Description
evaluated by EQ-5D questionnaire
Time Frame
after 1 year
Title
Morbi-mortality
Description
evaluated by non-recovery of functions, eventration and death
Time Frame
day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicla Settembre, MD, PhD
Phone
+33(0)383154384
Email
n.settembre@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sergueï Malikov, MD, PhD
Phone
+33(0)383153860
Email
s.malikov@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicla Settembre, MD, PhD
Organizational Affiliation
Department of vascular and endovascular surgery. Nancy University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Mini-laparotomy Versus Mini Lumbotomy
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