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| Name | Class |
|---|---|
| University Hospital, Gentofte, Copenhagen | OTHER |
| University of Copenhagen | OTHER |
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This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 ports laparoscopic cholecystectomy | Other |
| |
| One port transumb. laparoscopic surgery | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional laparoscopic procedure | Procedure | Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea scores on a 4 point scale before surgery | The 4 point scale: none, light, moderate, and severe | Before surgery |
| Nausea scores on a 4 point scale 3 hours after surgery | The 4 point scale: none, light, moderate, and severe |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars N Jorgensen, MD, DrMSc | Contact | +45 35316441 | larsnjorgensen@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Surgery K, Bispebjerg Hospital | Recruiting | Copenhagen NV | DK-2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24536008 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2014 | |
| Reset | May 13, 2014 | |
| Release | Jul 14, 2017 |
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|
| Experimental laparoscopic procedure | Procedure | Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port |
|
|
| 3 hours after surgery |
| Nausea scores on a 4 point scale 1 day surgery | The 4 point scale: none, light, moderate, and severe | 1 day after surgery |
| Nausea scores on a 4 point scale 2 days after surgery | The 4 point scale: none, light, moderate, and severe | 2 days after surgery |
| Nausea scores on a 4 point scale 3 days after surgery | The 4 point scale: none, light, moderate, and severe | 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 | Adverse events include all complications related to surgery | Within 30 days after surgery |
| Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery | 30 days after surgery |
| 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 |
| Gentofte Hospital, University of Copenhagen | Recruiting | Gentofte Municipality | DK-2920 | Denmark |
|
| Dept. of Surgery, Koege Hospital, University of Copenhagen | Recruiting | Koege | DK-4600 | Denmark |
|
| Reset | Feb 1, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2014 | May 13, 2014 | |||
| Jul 14, 2017 | Feb 1, 2018 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020250 | Postoperative Nausea and Vomiting |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |
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