Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
NCT ID: NCT00904865
Last Updated: 2009-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses.
Objective:
Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy.
Hypothesis:
SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed.
Methods:
All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally.
Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports.
Randomization will be performed before surgeries after patients have given their informed consent to the study.
No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent.
Endpoints:
* Morbidity
* Body image and Cosmetic results
* Post-operative pain (opioid sparing effect)
* Operative time
* Hospital stay
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
SPA cholecystectomy
SPA cholecystectomy
SPA cholecystectomy
2
laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Interventions
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SPA cholecystectomy
SPA cholecystectomy
Laparoscopic cholecystectomy
Laparoscopic cholecystectomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Liver disease
* Cognitive trouble
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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University Hospital Geneva
Principal Investigators
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Pascal Bucher, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
Locations
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University Hospital Geneva
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Bucher P, Pugin F, Buchs N, Ostermann S, Charara F, Morel P. Single port access laparoscopic cholecystectomy (with video). World J Surg. 2009 May;33(5):1015-9. doi: 10.1007/s00268-008-9874-4.
Bucher P, Pugin F, Buchs NC, Ostermann S, Morel P. Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy. Br J Surg. 2011 Dec;98(12):1695-702. doi: 10.1002/bjs.7689. Epub 2011 Sep 30.
Steinemann DC, Raptis DA, Lurje G, Oberkofler CE, Wyss R, Zehnder A, Lesurtel M, Vonlanthen R, Clavien PA, Breitenstein S. Cosmesis and body image after single-port laparoscopic or conventional laparoscopic cholecystectomy: a multicenter double blinded randomised controlled trial (SPOCC-trial). BMC Surg. 2011 Sep 12;11:24. doi: 10.1186/1471-2482-11-24.
Other Identifiers
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CER-08-145
Identifier Type: -
Identifier Source: org_study_id
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