Gallbladder Disease
Conditions
Keywords
single incision, cholecystectomy, laparoscopy
Brief summary
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
Detailed description
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.
Interventions
PROCEDURESILS cholecystectomy
Single incision laparoscopic cholecystectomy will be performed
PROCEDURETPCL cholecystectomy
Three port laparoscopic cholecystectomy will br performed
Sponsors
Maltepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Required laparoscopic cholecystectomy for gallbladder disease.
Exclusion criteria
* American Society of Anesthesiologists score (ASA) more than III, * Patients had prior abdominal surgery, * Patients admitted outside working hours with acute cholecystitis, * Patients have choledocolithiasis, * pregnancy, * ongoing peritoneal dialysis, * lack of written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score | 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 | Average of 70 minutes | Per operative complications will be recorded. * Bleeding * Gallbladder perforation * Bile leakage * Bowel perforation * Complications associated with increased intra-abdominal pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating time | Average of 70 minutes | The operating time will be defined as the time from the first incision to the last suture's placement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Average of 2 days | Length of hospital stay will be recorded postoperative period. |
| Postoperative complications | 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year | Postoperative complications will be recorded postoperative follow up. * Bleeding * Bile leakage * Intrabdominal injury * Wound infection * Port site hernia |
Outcome results
None listed