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Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

NCT00904865 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2009-05-20

No results posted yet for this study

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

Conditions

  • Symptomatic Gallbladder Stones
  • Cholecystitis
  • Biliary Pancreatitis

Interventions

PROCEDURE

SPA cholecystectomy

SPA cholecystectomy

PROCEDURE

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Pascal Bucher, MD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00904865 on ClinicalTrials.gov