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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
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    July 1, 2016
    Last Updated
    September 17, 2018
    Sponsor
    Central Hospital, Nancy, France
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    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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