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Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. Laparoscopic cholecystectomy has been recognized since 1987 as the gold standard procedure for gallbladder surgery. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study we aimed to compare results of SILS cholecystectomy and three port conventional laparoscopic (TPCL) cholecystectomy prospectively
Single-incision laparoscopic procedures have evolved gradually to include a multitude of various surgeries. The current literature documents the use of a single-incision or single-port access surgery for cholecystectomies, adrenalectomies, splenectomies, appendectomies, herniorrhaphies, bariatrics, and colon surgery.
Total of 100 patients who undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to undergo SILS cholecystectomy group (n = 50) or TPCL cholecystectomy group (n= 50) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to a standard or three port laparoscopic cholecystectomy, need for conversion to an open cholecystectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of bile leak, wound infection, hospital readmission, and hernia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | SILS cholecystectomy |
|
| Group 2 | Active Comparator | TPCL cholecystectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SILS cholecystectomy | Procedure | Single incision laparoscopic cholecystectomy will be performed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pain score | Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared. | Postoperative first 24 hours |
| Intraoperative complications | Per operative complications will be recorded.
| Average of 70 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | The operating time will be defined as the time from the first incision to the last suture's placement. | Average of 70 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Length of hospital stay will be recorded postoperative period. | Average of 2 days |
| Postoperative complications | Postoperative complications will be recorded postoperative follow up.
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UÄŸur Deveci, Ass. Prof. | Maltepe University, School of Medicine , General Surgery Department | Principal Investigator |
| Manuk N. Manukyan, Ass.Prof. | Maltepe University, School of Medicine, General Surgery Department | Study Director |
| Umut Barbaros, Ass.Prof. | Istanbul University, Istanbul Medical School, General Surgery Department | Principal Investigator |
| Abut Kebudi, Prof. | Maltepe University, School of Medicine, General Surgery Department | Study Chair |
| Sertan Kapakli, Ass.Prof. | Maltepe University, School of Medicine, General Surgery Department | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24368985 | Derived | Deveci U, Barbaros U, Kapakli MS, Manukyan MN, Simsek S, Kebudi A, Mercan S. The comparison of single incision laparoscopic cholecystectomy and three port laparoscopic cholecystectomy: prospective randomized study. J Korean Surg Soc. 2013 Dec;85(6):275-82. doi: 10.4174/jkss.2013.85.6.275. Epub 2013 Nov 26. |
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| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| TPCL cholecystectomy |
| Procedure |
Three port laparoscopic cholecystectomy will br performed |
|
| 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year |