Single Incision Laparoscopic Surgery (SILS) Versus Laparoscopic Cholecystectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00981604
First received: September 21, 2009
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.


Condition Intervention
Cholelithiasis
Biliary Dyskinesia
Procedure: SILS
Procedure: Standard Laparoscopic Cholecystectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Incision Versus Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Operative Time [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative complications [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • length of hospitalization [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • doses of analgesics [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • hospital/operation charges [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • surgeon perception of difficulty [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • cosmetic scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SILS Cholecystectomy
Single Incision Laparoscopic Cholecystectomy
Procedure: SILS
Single Incision Laparoscopic Cholecystectomy
Other Name: SILS
Active Comparator: Standard Laparoscopic Cholecystectomy
4 port laparoscopic cholecystectomy
Procedure: Standard Laparoscopic Cholecystectomy
4 port technique
Other Name: Laparoscopic Cholecystectomy

Detailed Description:

This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.

This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.

After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Need for cholecystectomy

Exclusion Criteria:

  • Need for cholangiogram
  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: NCT00981604

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Daniel J Ostlie, MD Children's Mercy Hospital Kansas City
  More Information

No publications provided by Children's Mercy Hospital Kansas City

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shawn St. Peter, MD, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00981604     History of Changes
Other Study ID Numbers: 09 07 132
Study First Received: September 21, 2009
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
SILS
Laparoscopic Cholecystectomy
Children

Additional relevant MeSH terms:
Biliary Dyskinesia
Cholecystolithiasis
Cholelithiasis
Dyskinesias
Gallstones
Bile Duct Diseases
Biliary Tract Diseases
Calculi
Central Nervous System Diseases
Common Bile Duct Diseases
Digestive System Diseases
Gallbladder Diseases
Movement Disorders
Nervous System Diseases
Neurologic Manifestations
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014