Mini-laparotomy Versus Mini Lumbotomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Aortic Aneurysms, Abdominal Aortic Thrombosis

Intervention / Treatment
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* Procedure: mini laparotomy
* Procedure: mini lumbotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mini-lumbotomy, mini-laparotomy, retroperitoneal approach, transperitoneal approach, abdominal aortic surgery