Clinical trial NCT01772745: The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy
Official title: The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallbladder Disease
Keywords: single incision
cholecystectomy
laparoscopy
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pain score
timeFrame: Postoperative first 24 hours
measure: Intraoperative complications
timeFrame: Average of 70 minutes
Secondary outcomes:
measure: Operating time
timeFrame: Average of 70 minutes
Other outcomes:
measure: Length of hospital stay
timeFrame: Average of 2 days
measure: Postoperative complications
timeFrame: 24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year
Locations:
Study officials:
affiliation: Maltepe University, School of Medicine , General Surgery Department
name: Uğur Deveci, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University, School of Medicine, General Surgery Department
name: Manuk N. Manukyan, Ass.Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University, Istanbul Medical School, General Surgery Department
name: Umut Barbaros, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maltepe University, School of Medicine, General Surgery Department
name: Abut Kebudi, Prof.
role: STUDY_CHAIR
affiliation: Maltepe University, School of Medicine, General Surgery Department
name: Sertan Kapakli, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.