An interventional study of SILS cholecystectomy and TPCL cholecystectomy in Gallbladder Disease, sponsored by Maltepe University. Completed. Per ClinicalTrials.gov, last updated 2013-01-21.
Sponsored by Maltepe University · Not applicable, Interventional, and Treatment
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.
91 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's enrollment of 100 is above the median of 84 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Maltepe University is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
SILS cholecystectomy
Procedure: SILS cholecystectomy
TPCL cholecystectomy
Procedure: TPCL cholecystectomy
Single incision laparoscopic cholecystectomy will be performed
Three port laparoscopic cholecystectomy will br performed
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.
Time frame: Postoperative first 24 hours
Intraoperative complications
Per operative complications will be recorded. * Bleeding * Gallbladder perforation * Bile leakage * Bowel perforation * Complications associated with increased intra-abdominal pressure
Time frame: Average of 70 minutes
Operating time
The operating time will be defined as the time from the first incision to the last suture's placement.
Time frame: Average of 70 minutes
Length of hospital stay
Length of hospital stay will be recorded postoperative period.
Time frame: Average of 2 days
Postoperative complications
Postoperative complications will be recorded postoperative follow up. * Bleeding * Bile leakage * Intrabdominal injury * Wound infection * Port site hernia
Time frame: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Maltepe University