NCT01268748

Brief Summary

This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

3 active sites

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

September 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 31, 2010

Status Verified

September 1, 2010

Enrollment Period

9 months

First QC Date

September 20, 2010

Last Update Submit

December 30, 2010

Conditions

Pain, PostoperativePostoperative Nausea and VomitingPostoperative Complications

Keywords

single site surgerylaparoscopic surgerypainnausea

Outcome Measures

Primary Outcomes (5)

  • Pain scores on the Visual Analog Scale before surgery

    Before surgery

  • Pain scores on the Visual Analog Scale 3 hours after surgery

    3 hrs after surgery

  • Pain scores on the Visual Analog Scale 1 day after surgery

    1 day after surgery

  • Pain scores on the Visual Analog Scale 2 days after surgery

    2 days after surgery

  • Pain scores on the Visual Analog Scale 3 days after surgery

    3 days after surgery

Secondary Outcomes (12)

  • Nausea scores on a 4 point scale before surgery

    Before surgery

  • Nausea scores on a 4 point scale 3 hours after surgery

    3 hours after surgery

  • Nausea scores on a 4 point scale 1 day surgery

    1 day after surgery

  • Nausea scores on a 4 point scale 2 days after surgery

    2 days after surgery

  • Nausea scores on a 4 point scale 3 days after surgery

    3 days after surgery

  • +7 more secondary outcomes

Study Arms (2)

4 ports laparoscopic cholecystectomy

OTHER
Procedure: Conventional laparoscopic procedure

One port transumb. laparoscopic surgery

OTHER
Procedure: Experimental laparoscopic procedure

Interventions

Conventional laparoscopic procedurePROCEDURE

Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports

Also known as: Versaport 12 mm, Versaport 5 mm
4 ports laparoscopic cholecystectomy
Experimental laparoscopic procedurePROCEDURE

Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port

Also known as: SILS port
One port transumb. laparoscopic surgery

Eligibility Criteria

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

You may qualify if:

  • ASA I-III
  • Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis

You may not qualify if:

  • Expected poor compliance
  • History of cholecystitis or severe pancreatitis
  • Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dept. of Surgery K, Bispebjerg Hospital

Copenhagen NV, DK-2400, Denmark

RECRUITING

Gentofte Hospital, University of Copenhagen

Gentofte Municipality, DK-2920, Denmark

RECRUITING

Dept. of Surgery, Koege Hospital, University of Copenhagen

Koege, DK-4600, Denmark

RECRUITING

Related Publications (1)

  • Jorgensen LN, Rosenberg J, Al-Tayar H, Assaadzadeh S, Helgstrand F, Bisgaard T. Randomized clinical trial of single- versus multi-incision laparoscopic cholecystectomy. Br J Surg. 2014 Mar;101(4):347-55. doi: 10.1002/bjs.9393.

    PMID: 24536008DERIVED

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and VomitingPostoperative ComplicationsPainNausea

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsSigns and Symptoms, DigestiveVomiting

Study Officials

  • Haytham Al-Tayar, MD

    Dept. of Surgery, Bispebjerg Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Sami Assaadzadeh, MD

    Dept. of Surgery, Gentofte Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Jacob Rosenberg, MD, DrMSc

    Dept. of Surgery, Herlev Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Flemming Hjørne, MD

    Dept. of Surgery, Køge Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • Thue Bisgaard, MD, DrMSc

    Dept. of Surgery, Køge Hospital, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars N Jorgensen, MD, DrMSc

CONTACT

+45 35316441larsnjorgensen@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 20, 2010

First Posted

December 31, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

December 31, 2010

Record last verified: 2010-09

Locations

DK(3)