Pain, Postoperative, Postoperative Complications, Postoperative Nausea and Vomiting
Conditions
Keywords
single site surgery, laparoscopic surgery, pain, nausea
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.
Interventions
PROCEDUREConventional laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
PROCEDUREExperimental laparoscopic procedure
Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
Sponsors
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Nausea scores on a 4 point scale 2 days after surgery | 2 days after surgery | The 4 point scale: none, light, moderate, and severe |
| 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 | Adverse events include all complications related to surgery |
| Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery | 30 days after surgery | — |
| Well being scores on the Visual Analog Scale 2 days after surgery | 2 days after surgery | — |
| Nausea scores on a 4 point scale before surgery | Before surgery | The 4 point scale: none, light, moderate, and severe |
| Nausea scores on a 4 point scale 3 hours after surgery | 3 hours after surgery | The 4 point scale: none, light, moderate, and severe |
| Nausea scores on a 4 point scale 1 day surgery | 1 day after surgery | The 4 point scale: none, light, moderate, and severe |
| Nausea scores on a 4 point scale 3 days after surgery | 3 days after surgery | The 4 point scale: none, light, moderate, and severe |
Countries
Denmark
Contacts
Primary ContactLars N Jorgensen, MD, DrMSc
Outcome results
None listed