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Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Primary Purpose

Symptomatic Gallbladder Stones, Cholecystitis, Biliary Pancreatitis

Status
Unknown status
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
SPA cholecystectomy
Laparoscopic cholecystectomy
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Gallbladder Stones focused on measuring Single port access, Laparoscopy, cholecystectomy, cholangiography, cosmesis

Eligibility Criteria

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

Inclusion Criteria:

  • Age more than 18 years

Exclusion Criteria:

  • Contraindication to laparoscopy
  • Liver disease
  • Cognitive trouble

Sites / Locations

  • University Hospital GenevaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

SPA cholecystectomy

laparoscopic cholecystectomy

Outcomes

Primary Outcome Measures

Cosmesis, body image and quality of life scale

Secondary Outcome Measures

Post-operative morbidity
Post-operative pain
Operative time

Full Information

First Posted
May 19, 2009
Last Updated
May 19, 2009
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT00904865
Brief Title
Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy
Official Title
Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Gallbladder Stones, Cholecystitis, Biliary Pancreatitis
Keywords
Single port access, Laparoscopy, cholecystectomy, cholangiography, cosmesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
SPA cholecystectomy
Arm Title
2
Arm Type
Other
Arm Description
laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
SPA cholecystectomy
Intervention Description
SPA cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy
Intervention Description
Laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
Cosmesis, body image and quality of life scale
Time Frame
at 1 month
Secondary Outcome Measure Information:
Title
Post-operative morbidity
Time Frame
at 30 days
Title
Post-operative pain
Time Frame
10 days
Title
Operative time
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age more than 18 years Exclusion Criteria: Contraindication to laparoscopy Liver disease Cognitive trouble
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Bucher, MD
Phone
+41223723311
Ext
7958420
Email
pascal.bucher@hcuge.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Bucher, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Bucher, MD
Phone
¦41223723311
Ext
7958420
Email
pascal.bucher@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Pascal Bucher, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19116734
Citation
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.
Results Reference
background
PubMed Identifier
21964736
Citation
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.
Results Reference
derived
PubMed Identifier
21910897
Citation
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.
Results Reference
derived

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Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

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