NCT01348620

Brief Summary

This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

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

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Last Updated

May 5, 2011

Status Verified

May 1, 2011

Enrollment Period

10 months

First QC Date

April 26, 2011

Last Update Submit

May 4, 2011

Conditions

Postoperative Pain

Keywords

single port cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain scores (visual analogue pain scale from 0-10)

    Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery

Secondary Outcomes (1)

  • Patient-assessed cosmesis on the Visual Analogue Scale

    30 days after surgery

Study Arms (2)

Single port laparoscopic device

EXPERIMENTAL
Device: Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)

Four-port laparoscopic device

ACTIVE COMPARATOR
Procedure: Four port laparoscopic cholecystectomy surgery

Interventions

Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)DEVICE

Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson \& Johnson Medical Spa)

Also known as: One-trocar cholecistectomy
Single port laparoscopic device
Four port laparoscopic cholecystectomy surgeryPROCEDURE

Four port laparoscopic cholecystectomy surgery

Also known as: traditional Laparoscopic cholecistectomy
Four-port laparoscopic device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biliary cholic
  • Biliary dyskinesia
  • Gallbladder polyps
  • Other diagnosis at the discretion of the surgeon

You may not qualify if:

  • History of Acute cholecystitis
  • Jaundice
  • Choledocolithiasis
  • History of Pancreatitis
  • Severe comorbidity
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sacro Cuore - Don Calabria Hospital

Negrar, Verona, 37024, Italy

RECRUITING

Related Publications (7)

  • Rao PP, Bhagwat SM, Rane A, Rao PP. The feasibility of single port laparoscopic cholecystectomy: a pilot study of 20 cases. HPB (Oxford). 2008;10(5):336-40. doi: 10.1080/13651820802276622.

    PMID: 18982149BACKGROUND

  • Hirano Y, Watanabe T, Uchida T, Yoshida S, Tawaraya K, Kato H, Hosokawa O. Single-incision laparoscopic cholecystectomy: single institution experience and literature review. World J Gastroenterol. 2010 Jan 14;16(2):270-4. doi: 10.3748/wjg.v16.i2.270.

    PMID: 20066749BACKGROUND

  • Tacchino R, Greco F, Matera D. Single-incision laparoscopic cholecystectomy: surgery without a visible scar. Surg Endosc. 2009 Apr;23(4):896-9. doi: 10.1007/s00464-008-0147-y. Epub 2008 Sep 25.

    PMID: 18815836BACKGROUND

  • Gumbs AA, Milone L, Sinha P, Bessler M. Totally transumbilical laparoscopic cholecystectomy. J Gastrointest Surg. 2009 Mar;13(3):533-4. doi: 10.1007/s11605-008-0614-8.

    PMID: 18709515BACKGROUND

  • Kuon Lee S, You YK, Park JH, Kim HJ, Lee KK, Kim DG. Single-port transumbilical laparoscopic cholecystectomy: a preliminary study in 37 patients with gallbladder disease. J Laparoendosc Adv Surg Tech A. 2009 Aug;19(4):495-9. doi: 10.1089/lap.2008.0424.

    PMID: 19630589BACKGROUND

  • Partelli S, Barugola G, Sartori A, Crippa S, Falconi M, Ruffo G. Single-incision laparoscopic cholecystectomy versus traditional laparoscopic cholecystectomy performed by a single surgeon: findings of a randomized trial. Surg Today. 2016 Mar;46(3):313-8. doi: 10.1007/s00595-015-1182-7. Epub 2015 Jun 3.

    PMID: 26036221DERIVED

  • 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

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Giuliano Barugola, MD

CONTACT

00390456013111barugolagiuliano@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

May 5, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Last Updated

May 5, 2011

Record last verified: 2011-05

Locations

IT(1)