Comparison Between Open & Laparoscopic Splenic Aneurysms NCT01387828

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01387828
Other study ID #	AOB 01-11
Secondary ID
Status	Completed
Phase	Phase 3
First received	July 1, 2011
Last updated	July 6, 2011
Start date	January 2001
Est. completion date	April 2011

Study information
Verified date	June 2011
Source	Azienda Ospedaliera Spedali Civili di Brescia
Contact	n/a
Is FDA regulated	No
Health authority	Italy: Ethics Committee
Study type	Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status	Completed
Enrollment	29
Est. completion date	April 2011
Est. primary completion date	April 2011
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic splenic aneurysm repair, eventual splenectomy
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
• Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy
Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach

Locations
Country	Name	City	State
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia	BS

Sponsors *(1)*
Lead Sponsor	Collaborator
Azienda Ospedaliera Spedali Civili di Brescia

Country where clinical trial is conducted

Italy,

References & Publications (23)

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. Epub 2002 Jul 1. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. Review. — View Citation

Holdsworth RJ, Gunn A. Ruptured splenic artery aneurysm in pregnancy. A review. Br J Obstet Gynaecol. 1992 Jul;99(7):595-7. Review. — View 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. — View 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. — View 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. — View Citation

Mastracci TM, Cadeddu M, Colopinto RF, Cinà 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. — View Citation

Mattar SG, Lumsden AB. The management of splenic artery aneurysms: experience with 23 cases. Am J Surg. 1995 Jun;169(6):580-4. — View Citation

Meinke AK, Floch NR, Dicorato MP. Laparoscopic options in the treatment of splenic artery aneurysms. Surg Endosc. 2002 Jul;16(7):1107. Epub 2002 May 3. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Epub 2005 Feb 3. — View 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. — View 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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Resumption of oral diet	Time between the intervention and patient oral intake without problems	Partcipants will be followed for the duration of hospital stay, an expected average of one week	No
Secondary	Intra-abdominal surgical drain removal time	Time between intervention and removal of surgical drain	Partcipants will be followed for the duration of hospital stay, an expected average of one week	No
Secondary	Hospital stay length	Time between intervention and discharge	Partcipants will be followed for the duration of hospital stay, an expected average of one week	No

Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (1)

Country where clinical trial is conducted

References & Publications (23)

Outcome