Clinical trial NCT01268748: Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain
Official title: Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Postoperative Complications
Keywords: single site surgery
laparoscopic surgery
pain
nausea
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: University of Copenhagen
First posted: 2010-12-31
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain scores on the Visual Analog Scale before surgery
timeFrame: Before surgery
measure: Pain scores on the Visual Analog Scale 3 hours after surgery
timeFrame: 3 hrs after surgery
measure: Pain scores on the Visual Analog Scale 1 day after surgery
timeFrame: 1 day after surgery
measure: Pain scores on the Visual Analog Scale 2 days after surgery
timeFrame: 2 days after surgery
measure: Pain scores on the Visual Analog Scale 3 days after surgery
timeFrame: 3 days after surgery
Secondary outcomes:
measure: Nausea scores on a 4 point scale before surgery
timeFrame: Before surgery
measure: Nausea scores on a 4 point scale 3 hours after surgery
timeFrame: 3 hours after surgery
measure: Nausea scores on a 4 point scale 1 day surgery
timeFrame: 1 day after surgery
measure: Nausea scores on a 4 point scale 2 days after surgery
timeFrame: 2 days after surgery
measure: Nausea scores on a 4 point scale 3 days after surgery
timeFrame: 3 days after surgery
measure: Well being scores on the Visual Analog Scale before surgery
timeFrame: Before surgery
measure: Well being scores on the Visual Analog Scale 3 hours after surgery
timeFrame: 3 hours after surgery
measure: Well being scores on the Visual Analog Scale 1 day after surgery
timeFrame: 1 day after surgery
measure: Well being scores on the Visual Analog Scale 2 days after surgery
timeFrame: 2 days after surgery
measure: Well being scores on the Visual Analog Scale 3 days after surgery
timeFrame: 3 days after surgery
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Within 30 days after surgery
measure: Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Dept. of Surgery K, Bispebjerg Hospital
city: Gentofte
country: Denmark
facility: Gentofte Hospital, University of Copenhagen
city: Koege
country: Denmark
facility: Dept. of Surgery, Koege Hospital, University of Copenhagen
Study officials:
affiliation: Dept. of Surgery, Bispebjerg Hospital, University of Copenhagen
name: Haytham Al-Tayar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Surgery, Gentofte Hospital, University of Copenhagen
name: Sami Assaadzadeh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Surgery, Herlev Hospital, University of Copenhagen
name: Jacob Rosenberg, MD, DrMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Surgery, Køge Hospital, University of Copenhagen
name: Flemming Hjørne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Surgery, Køge Hospital, University of Copenhagen
name: Thue Bisgaard, MD, DrMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.