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The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D laparoscopic cholecystectomy | Active Comparator | The normal laparoscopic cholecystectomy with two dimensional view |
|
| 3D laparoscopic cholecystectomy | Experimental | The normal laparoscopic cholecystectomy with three dimensional view |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2D laparoscopic cholecystectomy | Procedure |
| ||
| 3D laparoscopic cholecystectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of surgery | Expected average time of surgery 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Need for conversion into open surgery | During the operation, expected average time of surgery 1 hour | |
| Intraoperative complications | Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernias | after 1, 5 and 10 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ville Sallinen, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30710315 | Derived | Koppatz H, Harju J, Siren J, Mentula P, Scheinin T, Sallinen V. Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study. Surg Endosc. 2019 Nov;33(11):3725-3731. doi: 10.1007/s00464-019-06666-5. Epub 2019 Feb 1. |
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| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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| Procedure |
|
| During the operation, expected average time of surgery 1 hour |
| Complications, Clavien-Dindo classification | 30 days after randomization |
| Postoperative stay in hospital | Expected range 0-7 day |
| Bleeding | During the operation, expected average time of surgery 1 hour |
| Number of participants with readmission(s) | 30 days after randomization |
| Total need of opioids in milligrams | Expected range 0-7 day |
| Mortality | 30 days after randomization |
| Operation theatre time | Expected average 1,5 hours |
| Postoperative pain, VAS | Expected range 0-7 day |