NCT00904865

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Last Updated

May 20, 2009

Status Verified

May 1, 2009

Enrollment Period

2 years

First QC Date

May 19, 2009

Last Update Submit

May 19, 2009

Conditions

Symptomatic Gallbladder StonesCholecystitisBiliary Pancreatitis

Keywords

Single port accessLaparoscopycholecystectomycholangiographycosmesis

Outcome Measures

Primary Outcomes (1)

  • Cosmesis, body image and quality of life scale

    at 1 month

Secondary Outcomes (3)

  • Post-operative morbidity

    at 30 days

  • Post-operative pain

    10 days

  • Operative time

    day 1

Study Arms (2)

1

OTHER

SPA cholecystectomy

Procedure: SPA cholecystectomy

2

OTHER

laparoscopic cholecystectomy

Procedure: Laparoscopic cholecystectomy

Interventions

SPA cholecystectomyPROCEDURE

SPA cholecystectomy

1
Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age more than 18 years

You may not qualify if:

  • Contraindication to laparoscopy
  • Liver disease
  • Cognitive trouble

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19116734BACKGROUND

  • 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.

    PMID: 21964736DERIVED

  • 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.

    PMID: 21910897DERIVED

MeSH Terms

Conditions

Cholecystitis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Gallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Study Officials

  • Pascal Bucher, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Bucher, MD

CONTACT

+41223723311pascal.bucher@hcuge.ch

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Last Updated

May 20, 2009

Record last verified: 2009-05

Locations

CH(1)