The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy
|ClinicalTrials.gov Identifier: NCT01772745|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gallbladder Disease||Procedure: SILS cholecystectomy Procedure: TPCL cholecystectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: Group 1
Procedure: SILS cholecystectomy
Single incision laparoscopic cholecystectomy will be performed
Active Comparator: Group 2
Procedure: TPCL cholecystectomy
Three port laparoscopic cholecystectomy will br performed
- pain score [ Time Frame: Postoperative first 24 hours ]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.
- Intraoperative complications [ Time Frame: Average of 70 minutes ]
Per operative complications will be recorded.
- Gallbladder perforation
- Bile leakage
- Bowel perforation
- Complications associated with increased intra-abdominal pressure
- Operating time [ Time Frame: Average of 70 minutes ]The operating time will be defined as the time from the first incision to the last suture's placement.
- Length of hospital stay [ Time Frame: Average of 2 days ]Length of hospital stay will be recorded postoperative period.
- Postoperative complications [ Time Frame: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year ]
Postoperative complications will be recorded postoperative follow up.
- Bile leakage
- Intrabdominal injury
- Wound infection
- Port site hernia
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772745
|Principal Investigator:||Uğur Deveci, Ass. Prof.||Maltepe University, School of Medicine , General Surgery Department|
|Study Director:||Manuk N. Manukyan, Ass.Prof.||Maltepe University, School of Medicine, General Surgery Department|
|Principal Investigator:||Umut Barbaros, Ass.Prof.||Istanbul University, Istanbul Medical School, General Surgery Department|
|Study Chair:||Abut Kebudi, Prof.||Maltepe University, School of Medicine, General Surgery Department|
|Principal Investigator:||Sertan Kapakli, Ass.Prof.||Maltepe University, School of Medicine, General Surgery Department|