COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772745
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : January 21, 2013
Information provided by (Responsible Party):
manuk norayk manukyan, Maltepe University

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

Condition or disease Intervention/treatment Phase
Gallbladder Disease Procedure: SILS cholecystectomy Procedure: TPCL cholecystectomy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group 1
SILS cholecystectomy
Procedure: SILS cholecystectomy
Single incision laparoscopic cholecystectomy will be performed

Active Comparator: Group 2
TPCL cholecystectomy
Procedure: TPCL cholecystectomy
Three port laparoscopic cholecystectomy will br performed

Primary Outcome Measures :
  1. 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.

  2. Intraoperative complications [ Time Frame: 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 Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. Length of hospital stay [ Time Frame: Average of 2 days ]
    Length of hospital stay will be recorded postoperative period.

  2. 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.

    • Bleeding
    • Bile leakage
    • Intrabdominal injury
    • Wound infection
    • Port site hernia

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772745

Sponsors and Collaborators
Maltepe University
Layout table for investigator information
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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: manuk norayk manukyan, Ass.Prof., Maltepe University Identifier: NCT01772745    
Other Study ID Numbers: mütf3
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013
Keywords provided by manuk norayk manukyan, Maltepe University:
single incision
Additional relevant MeSH terms:
Layout table for MeSH terms
Gallbladder Diseases
Surgical Wound
Wounds and Injuries
Biliary Tract Diseases
Digestive System Diseases