Single Port Access (SPA) Cholecystectomy Versus Standard Laparoscopic Cholecystectomy

University Hospitals (UH)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cholecystitis; Biliary Pancreatitis; Symptomatic Gallbladder Stones

Treatments: Procedure: SPA cholecystectomy; Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00904865

CER-08-145

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age more than 18 years

Exclusion criteria

• Contraindication to laparoscopy
• Liver disease
• Cognitive trouble

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

1

Other group

Description:

SPA cholecystectomy

Treatment:

Procedure: SPA cholecystectomy

2

Other group

Description:

laparoscopic cholecystectomy

Treatment:

Procedure: Laparoscopic cholecystectomy