Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain

Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain

Sponsors

Lead Sponsor: Bispebjerg Hospital

Collaborator: University Hospital, Gentofte, Copenhagen
University of Copenhagen

Source Bispebjerg Hospital
Brief Summary

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

Detailed Description

This study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. Three centers participate in the trial.

Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis.

Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery.

Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation.

Cosmesis is evaluated after 28 days.

Patients are telephone-interviewed after 12 months and asked about port hernia formation. If hernia is suspected patients are called in for an abdominal ultrasonography.

Overall Status Unknown status
Start Date September 2010
Completion Date June 2012
Primary Completion Date June 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
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
Well being scores on the Visual Analog Scale before surgery Before surgery
Well being scores on the Visual Analog Scale 3 hours after surgery 3 hours after surgery
Well being scores on the Visual Analog Scale 1 day after surgery 1 day after surgery
Well being scores on the Visual Analog Scale 2 days after surgery 2 days after surgery
Well being scores on the Visual Analog Scale 3 days after surgery 3 days after surgery
Number of participants with adverse events as a measure of safety and tolerability Within 30 days after surgery
Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery 30 days after surgery
Enrollment 120
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Conventional laparoscopic procedure

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

Arm Group Label: 4 ports laparoscopic cholecystectomy

Intervention Type: Procedure

Intervention Name: Experimental laparoscopic procedure

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

Arm Group Label: One port transumb. laparoscopic surgery

Other Name: SILS port

Eligibility

Criteria:

Inclusion Criteria:

- ASA I-III

- Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis

Exclusion Criteria:

- Expected poor compliance

- History of cholecystitis or severe pancreatitis

- Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery

Gender: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Lars N Jorgensen, MD, DrMSc

Phone: +45 35316441

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Dept. of Surgery K, Bispebjerg Hospital | Copenhagen NV, DK-2400, Denmark Recruiting Lars N Jorgensen, MD, DrMSc +45 35316441 [email protected] Lars N Jorgensen, MD, DrMSc Principal Investigator Haytham Al-Tayar, MD Sub-Investigator
Gentofte Hospital, University of Copenhagen | Gentofte, DK-2920, Denmark Recruiting Jacob Rosenberg, MD, DrMSc +45 44883433 [email protected] Jacob Rosenberg, MD, DrMSc Principal Investigator Sami Assaadzadeh, MD Sub-Investigator
Dept. of Surgery, Koege Hospital, University of Copenhagen | Koege, DK-4600, Denmark Recruiting Thue Bisgaard, MD, DrMSc +45 47323224 [email protected] Thue Bisgaard, MD, DrMSc Principal Investigator Flemming Hjørne, MD Sub-Investigator
Location Countries

Denmark

Verification Date

September 2010

Responsible Party

Name Title: Lars Nannestad Jorgensen MD, DrMSc, Professor

Organization: Dept. of Surgery K, Bispebjerg Hospital, University of Copenhagen, DK-2400 Copenhagen NV, Denmark

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 4 ports laparoscopic cholecystectomy

Type: Other

Label: One port transumb. laparoscopic surgery

Type: Other

Acronym UMBI-CHOL
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov