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Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

NCT01268748 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2010-12-31

No results posted yet for this study

Summary

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

Conditions

  • Pain, Postoperative
  • Postoperative Nausea and Vomiting
  • Postoperative Complications

Interventions

PROCEDURE

Conventional laparoscopic procedure

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

PROCEDURE

Experimental laparoscopic procedure

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

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Haytham Al-Tayar, MD · Dept. of Surgery, Bispebjerg Hospital, University of Copenhagen

  • Sami Assaadzadeh, MD · Dept. of Surgery, Gentofte Hospital, University of Copenhagen

  • Jacob Rosenberg, MD, DrMSc · Dept. of Surgery, Herlev Hospital, University of Copenhagen

  • Flemming Hjørne, MD · Dept. of Surgery, Køge Hospital, University of Copenhagen

  • Thue Bisgaard, MD, DrMSc · Dept. of Surgery, Køge Hospital, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-06-30
Completion
2012-06-30

Countries

  • Denmark

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 NCT01268748 on ClinicalTrials.gov