Comparison Between Open and Laparoscopic Splenic Aneurysms Repair

NCT01387828 — Phase 3, Completed, 29 participants, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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Prospective Randomized Comparison of Open Versus Laparoscopic Management of Splenic Artery Aneurysms. A Ten-Year Study

RegistryNCT01387828
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment29 (Actual)
SponsorAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
ConditionsSplenic Artery Aneurysm
InterventionsLaparoscopic splenic aneurysm repair, eventual splenectomy, Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy (Procedure)
Datesstart 2001-01-01, primary completion 2011-04-01, completion 2011-04-01, first posted 2011-07-06, last updated 2011-07-07
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Splenic Artery Aneurysm All trials of Laparoscopic splenic aneurysm repair, eventual splenectomy All trials of Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy

-Summary

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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
LaparoscopyActive comparatorProcedure: Laparoscopic splenic aneurysm repair, eventual splenectomyIncludes all patient underwent intervention with a laparoscopic approach, even if converted to open surgery during intervention
Open surgeryActive comparatorProcedure: Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomyIncludes all the patients underwent intervention with a laparotomic approach; it does not include patient underwent laparoscopic approach and then converted in laparotomy.
  • Laparoscopic splenic aneurysm repair, eventual splenectomy (Procedure): Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
  • Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy (Procedure): Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach

+Outcome measures

Primary outcomes

  • Overall postoperative morbidity rate [During and after hospital stay, an expected average of 50 months]: 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 outcomes

  • Resumption of oral diet [Partcipants will be followed for the duration of hospital stay, an expected average of one week]: Time between the intervention and patient oral intake without problems
  • Intra-abdominal surgical drain removal time [Partcipants will be followed for the duration of hospital stay, an expected average of one week]: Time between intervention and removal of surgical drain
  • Hospital stay length [Partcipants will be followed for the duration of hospital stay, an expected average of one week]: Time between intervention and discharge

+Eligibility

Sex: All

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

+Locations (1)

FacilityCityCountryStatus
Azienda Ospedaliera Spedali Civili di BresciaBrescia, BSItaly

+Publications

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  • 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 10394168
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  • 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 19692887
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  • 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 12089631
  • 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 11336361
  • 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 11754862
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  • 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 14627251
  • 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 7771620
  • 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 19877249
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+Investigators