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Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

Single Port Access Cholecystectomy Versus Standard Laparoscopic Cholecystectomy - Randomized Study

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00904865
Enrollment
200
Registered
2009-05-20
Start date
2009-02-28
Completion date
Unknown
Last updated
2009-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Pancreatitis, Cholecystitis, Symptomatic Gallbladder Stones

Keywords

Single port access, Laparoscopy, cholecystectomy, cholangiography, cosmesis

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

Interventions

PROCEDURESPA cholecystectomy

SPA cholecystectomy

PROCEDURELaparoscopic cholecystectomy

Laparoscopic cholecystectomy

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age more than 18 years

Exclusion criteria

* Contraindication to laparoscopy * Liver disease * Cognitive trouble

Design outcomes

Primary

MeasureTime frame
Cosmesis, body image and quality of life scaleat 1 month

Secondary

MeasureTime frame
Post-operative morbidityat 30 days
Post-operative pain10 days
Operative timeday 1

Countries

Switzerland

Contacts

Primary ContactPascal Bucher, MD
pascal.bucher@hcuge.ch+41223723311

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026