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Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

Primary Purpose

Splenic Artery Aneurysm

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Laparoscopic splenic aneurysm repair, eventual splenectomy
Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Splenic Artery Aneurysm focused on measuring Splenic artery, Aneurysm, laparoscopic, Vascular reconstruction, Splenectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Splenic artery aneurysm with diameter greater than 2 cm
  • Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter)

Exclusion Criteria:

  • Complex aneurysm involving the celiac trunk
  • American Society of Anesthesiologists (ASA) Score > 3

Sites / Locations

  • Azienda Ospedaliera Spedali Civili di Brescia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopy

Open surgery

Arm Description

Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention

Includes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy.

Outcomes

Primary Outcome Measures

Overall postoperative morbidity rate
According to Dindo-Clavien classification of postoperative complication, we collect in a prospective way and classify all the possible complication by direct clinical evaluation and additional blood sample, imaging or endoscopy if required.

Secondary Outcome Measures

Resumption of oral diet
Time between the intervention and patient oral intake without problems
Intra-abdominal surgical drain removal time
Time between intervention and removal of surgical drain
Hospital stay length
Time between intervention and discharge

Full Information

First Posted
July 1, 2011
Last Updated
July 6, 2011
Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT01387828
Brief Title
Comparison Between Open and Laparoscopic Splenic Aneurysms Repair
Official Title
Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.
Detailed Description
Laparoscopy has not spread into vascular surgery as it has in other surgical branches and still remains in the hands of a minority of surgeons. Splenic artery aneurysm (SAA) is an exception to the rule: an easy-to-reach position and relatively safe control favour the progressive diffusion of laparoscopic techniques. An increasing number of cases is managed by minimally invasive surgery originating a number of case reports and small series published in recent literature. These papers are unanimous in signalling the feasibility, safety and effectiveness of laparoscopic technique as well as its appreciation by patients -often young females- who harbour the disease. However, perplexities still remain concerning the real potential of laparoscopy in this specific field, in particular considering the spectrum of technical solutions to be performed, the splenectomy rate and the feasibility and results of reconstructive surgery. The low incidence of the disease justifies the low number of published laparoscopic series enrolling an adequate number of patients and, in particular, the absence of papers comparing open and laparoscopic techniques. This study reports the first prospective randomized comparison of the different surgical techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Splenic Artery Aneurysm
Keywords
Splenic artery, Aneurysm, laparoscopic, Vascular reconstruction, Splenectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopy
Arm Type
Active Comparator
Arm Description
Includes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention
Arm Title
Open surgery
Arm Type
Active Comparator
Arm Description
Includes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic splenic aneurysm repair, eventual splenectomy
Intervention Description
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
Intervention Type
Procedure
Intervention Name(s)
Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
Intervention Description
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach
Primary Outcome Measure Information:
Title
Overall postoperative morbidity rate
Description
According to Dindo-Clavien classification of postoperative complication, we collect in a prospective way and classify all the possible complication by direct clinical evaluation and additional blood sample, imaging or endoscopy if required.
Time Frame
During and after hospital stay, an expected average of 50 months
Secondary Outcome Measure Information:
Title
Resumption of oral diet
Description
Time between the intervention and patient oral intake without problems
Time Frame
Partcipants will be followed for the duration of hospital stay, an expected average of one week
Title
Intra-abdominal surgical drain removal time
Description
Time between intervention and removal of surgical drain
Time Frame
Partcipants will be followed for the duration of hospital stay, an expected average of one week
Title
Hospital stay length
Description
Time between intervention and discharge
Time Frame
Partcipants will be followed for the duration of hospital stay, an expected average of one week

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Splenic artery aneurysm with diameter greater than 2 cm Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter) Exclusion Criteria: Complex aneurysm involving the celiac trunk American Society of Anesthesiologists (ASA) Score > 3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido AM Tiberio, MD
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19390269
Citation
Ha JF, Sieunarine K. Laparoscopic splenic artery aneurysm resection: review of current trends in management. Surg Laparosc Endosc Percutan Tech. 2009 Apr;19(2):e67-70. doi: 10.1097/SLE.0b013e31819bd4e7.
Results Reference
background
PubMed Identifier
10394168
Citation
Arca MJ, Gagner M, Heniford BT, Sullivan TM, Beven EG. Splenic artery aneurysms: methods of laparoscopic repair. J Vasc Surg. 1999 Jul;30(1):184-8. doi: 10.1016/s0741-5214(99)70190-4.
Results Reference
background
PubMed Identifier
19631859
Citation
Pietrabissa A, Ferrari M, Berchiolli R, Morelli L, Pugliese L, Ferrari V, Mosca F. Laparoscopic treatment of splenic artery aneurysms. J Vasc Surg. 2009 Aug;50(2):275-9. doi: 10.1016/j.jvs.2009.03.015.
Results Reference
background
PubMed Identifier
12397723
Citation
Suzuki H, Shimura T, Asao T, Nomoto K, Kanoh K, Tuboi K, Wada S, Kuwano H. Laparoscopic resection of splenic artery aneurysm; a case report. Hepatogastroenterology. 2002 Nov-Dec;49(48):1520-2.
Results Reference
background
PubMed Identifier
19692887
Citation
Obuchi T, Sasaki A, Nakajima J, Nitta H, Otsuka K, Wakabayashi G. Laparoscopic surgery for splenic artery aneurysm. Surg Laparosc Endosc Percutan Tech. 2009 Aug;19(4):338-40. doi: 10.1097/SLE.0b013e3181a89206.
Results Reference
background
PubMed Identifier
15959711
Citation
Reardon PR, Otah E, Craig ES, Matthews BD, Reardon MJ. Laparoscopic resection of splenic artery aneurysms. Surg Endosc. 2005 Apr;19(4):488-93. doi: 10.1007/s00464-004-8916-8. Epub 2005 Feb 3.
Results Reference
background
PubMed Identifier
11444759
Citation
de Csepel J, Quinn T, Gagner M. Laparoscopic exclusion of a splenic artery aneurysm using a lateral approach permits preservation of the spleen. Surg Laparosc Endosc Percutan Tech. 2001 Jun;11(3):221-4.
Results Reference
background
PubMed Identifier
16773011
Citation
Sandford RM, Lloyd DM, Ross Naylor A. Laparoscopic ligation of splenic artery aneurysm. Surg Laparosc Endosc Percutan Tech. 2006 Apr;16(2):102-3. doi: 10.1097/00129689-200604000-00010.
Results Reference
background
PubMed Identifier
10854524
Citation
Adham M, Blanc P, Douek P, Henri L, Ducerf C, Baulieux J. Laparoscopic resection of a proximal splenic artery aneurysm. Surg Endosc. 2000 Apr;14(4):372. doi: 10.1007/s004640010051.
Results Reference
background
PubMed Identifier
11984676
Citation
Meinke AK, Floch NR, Dicorato MP. Laparoscopic options in the treatment of splenic artery aneurysms. Surg Endosc. 2002 Jul;16(7):1107. doi: 10.1007/s00464-002-0003-4. Epub 2002 May 3.
Results Reference
background
PubMed Identifier
15944609
Citation
Mastracci TM, Cadeddu M, Colopinto RF, Cina C. A minimally invasive approach to the treatment of aberrant splenic artery aneurysms: a report of two cases. J Vasc Surg. 2005 Jun;41(6):1053-7. doi: 10.1016/j.jvs.2005.01.056.
Results Reference
background
PubMed Identifier
1525102
Citation
Holdsworth RJ, Gunn A. Ruptured splenic artery aneurysm in pregnancy. A review. Br J Obstet Gynaecol. 1992 Jul;99(7):595-7. doi: 10.1111/j.1471-0528.1992.tb13828.x. No abstract available.
Results Reference
background
PubMed Identifier
19596508
Citation
Ha JF, Phillips M, Faulkner K. Splenic artery aneurysm rupture in pregnancy. Eur J Obstet Gynecol Reprod Biol. 2009 Oct;146(2):133-7. doi: 10.1016/j.ejogrb.2009.05.034. Epub 2009 Jul 10.
Results Reference
background
PubMed Identifier
12089631
Citation
Abbas MA, Stone WM, Fowl RJ, Gloviczki P, Oldenburg WA, Pairolero PC, Hallett JW, Bower TC, Panneton JM, Cherry KJ. Splenic artery aneurysms: two decades experience at Mayo clinic. Ann Vasc Surg. 2002 Jul;16(4):442-9. doi: 10.1007/s10016-001-0207-4. Epub 2002 Jul 1.
Results Reference
background
PubMed Identifier
11336361
Citation
Jung SI, Joh YG, Um JW, Suh SO, Whang CW, Corbascio M. The Seoul experience of splenic artery aneurysms. Ann Chir Gynaecol. 2001;90(1):10-4.
Results Reference
background
PubMed Identifier
11754862
Citation
Pulli R, Innocenti AA, Barbanti E, Dorigo W, Turini F, Gatti M, Pratesi C. Early and long-term results of surgical treatment of splenic artery aneurysms. Am J Surg. 2001 Nov;182(5):520-3. doi: 10.1016/s0002-9610(01)00744-9.
Results Reference
background
PubMed Identifier
17243878
Citation
Kokkalera U, Bhende S, Ghellai A. Laparoscopic management of splenic artery aneurysms. J Laparoendosc Adv Surg Tech A. 2006 Dec;16(6):604-8. doi: 10.1089/lap.2006.16.604.
Results Reference
background
PubMed Identifier
20569943
Citation
Al-Habbal Y, Christophi C, Muralidharan V. Aneurysms of the splenic artery - a review. Surgeon. 2010 Aug;8(4):223-31. doi: 10.1016/j.surge.2009.11.011. Epub 2010 Mar 12.
Results Reference
background
PubMed Identifier
14627251
Citation
Heestand G, Sher L, Lightfoote J, Palmer S, Mateo R, Singh G, Moser J, Selby R, Genyk Y, Jabbour N. Characteristics and management of splenic artery aneurysm in liver transplant candidates and recipients. Am Surg. 2003 Nov;69(11):933-40.
Results Reference
background
PubMed Identifier
7771620
Citation
Mattar SG, Lumsden AB. The management of splenic artery aneurysms: experience with 23 cases. Am J Surg. 1995 Jun;169(6):580-4. doi: 10.1016/s0002-9610(99)80225-6.
Results Reference
background
PubMed Identifier
19877249
Citation
Moon DB, Lee SG, Hwang S, Kim KH, Ahn CS, Ha TY, Song GW, Jung DH, Ko GY, Sung KB. Characteristics and management of splenic artery aneurysms in adult living donor liver transplant recipients. Liver Transpl. 2009 Nov;15(11):1535-41. doi: 10.1002/lt.21885.
Results Reference
background
PubMed Identifier
21276711
Citation
Giulianotti PC, Buchs NC, Coratti A, Sbrana F, Lombardi A, Felicioni L, Bianco FM, Addeo P. Robot-assisted treatment of splenic artery aneurysms. Ann Vasc Surg. 2011 Apr;25(3):377-83. doi: 10.1016/j.avsg.2010.09.014. Epub 2011 Jan 28.
Results Reference
background
PubMed Identifier
19037534
Citation
Lee SY, Florica O. Laparoscopic resection of splenic artery aneurysm with preservation of splenic function. Singapore Med J. 2008 Nov;49(11):e303-4.
Results Reference
background

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Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

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