NCT01387828

Brief Summary

The purpose of this study is compare two different surgical treatments of splenic artery aneurysms: open and laparoscopic approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
Last Updated

July 7, 2011

Status Verified

June 1, 2011

Enrollment Period

10.3 years

First QC Date

July 1, 2011

Last Update Submit

July 6, 2011

Conditions

Splenic Artery Aneurysm

Keywords

Splenic arteryAneurysmlaparoscopicVascular reconstructionSplenectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    During and after hospital stay, an expected average of 50 months

Secondary Outcomes (3)

  • Resumption of oral diet

    Partcipants will be followed for the duration of hospital stay, an expected average of one week

  • Intra-abdominal surgical drain removal time

    Partcipants will be followed for the duration of hospital stay, an expected average of one week

  • Hospital stay length

    Partcipants will be followed for the duration of hospital stay, an expected average of one week

Study Arms (2)

Laparoscopy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic splenic aneurysm repair, eventual splenectomy

Open surgery

ACTIVE COMPARATOR

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

Procedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy

Interventions

Laparoscopic splenic aneurysm repair, eventual splenectomyPROCEDURE

Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach

Laparoscopy
Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomyPROCEDURE

Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach

Open surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Related Publications (23)

  • 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.

    PMID: 19390269BACKGROUND

  • 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.

    PMID: 10394168BACKGROUND

  • 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.

    PMID: 19631859BACKGROUND

  • 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.

    PMID: 12397723BACKGROUND

  • 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.

    PMID: 19692887BACKGROUND

  • 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.

    PMID: 15959711BACKGROUND

  • 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.

    PMID: 11444759BACKGROUND

  • 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.

    PMID: 16773011BACKGROUND

  • 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.

    PMID: 10854524BACKGROUND

  • 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.

    PMID: 11984676BACKGROUND

  • 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.

    PMID: 15944609BACKGROUND

  • 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.

    PMID: 1525102BACKGROUND

  • 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.

    PMID: 19596508BACKGROUND

  • 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.

    PMID: 12089631BACKGROUND

  • 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.

    PMID: 11336361BACKGROUND

  • 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.

    PMID: 11754862BACKGROUND

  • 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.

    PMID: 17243878BACKGROUND

  • 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.

    PMID: 20569943BACKGROUND

  • 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.

    PMID: 14627251BACKGROUND

  • 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.

    PMID: 7771620BACKGROUND

  • 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.

    PMID: 19877249BACKGROUND

  • 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.

    PMID: 21276711BACKGROUND

  • Lee SY, Florica O. Laparoscopic resection of splenic artery aneurysm with preservation of splenic function. Singapore Med J. 2008 Nov;49(11):e303-4.

    PMID: 19037534BACKGROUND

MeSH Terms

Conditions

Aneurysm

Interventions

Splenectomy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Guido AM Tiberio, MD

    Università degli Studi di Brescia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 6, 2011

Study Start

January 1, 2001

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

July 7, 2011

Record last verified: 2011-06

Locations

IT(1)