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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
manuk norayk manukyan, Maltepe University
ClinicalTrials.gov Identifier:
NCT01772745
First received: January 16, 2013
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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 Intervention
Gallbladder Disease
Procedure: SILS cholecystectomy
Procedure: TPCL cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Comparison of Single Incision Laparoscopic Cholecystectomy and Three Port Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Maltepe University:

Primary Outcome Measures:
  • pain score [ Time Frame: Postoperative first 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    Per operative complications will be recorded.

    • Bleeding
    • Gallbladder perforation
    • Bile leakage
    • Bowel perforation
    • Complications associated with increased intra-abdominal pressure


Secondary Outcome Measures:
  • Operating time [ Time Frame: Average of 70 minutes ] [ Designated as safety issue: No ]
    The operating time will be defined as the time from the first incision to the last suture's placement.


Other Outcome Measures:
  • Length of hospital stay [ Time Frame: Average of 2 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    Postoperative complications will be recorded postoperative follow up.

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


Enrollment: 100
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772745

Sponsors and Collaborators
Maltepe University
Investigators
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
  More Information

No publications provided

Responsible Party: manuk norayk manukyan, Ass.Prof., Maltepe University
ClinicalTrials.gov Identifier: NCT01772745     History of Changes
Other Study ID Numbers: mütf3
Study First Received: January 16, 2013
Last Updated: January 17, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Maltepe University:
single incision
cholecystectomy
laparoscopy

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 28, 2014