- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852408
Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy
August 1, 2016 updated by: Fatih Basak, Umraniye Education and Research Hospital
Unintentional Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy: A Prospective Controlled Blinded Trial
Laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone.
Although it has low morbidity, postoperative pain is challenging situation like every other operation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain after laparoscopic cholecystectomy has a three component: parietal, visceral and referring (shoulder) pain.
Although intensities of them can be various, all of them affects the total pain together.
Unintentional liver cauterization during laparoscopic cholecystectomy is unwanted, but sometimes unavoidable complication/process. However its effect on postoperative pain is not studied with detail in literature.
Study Type
Observational
Enrollment (Actual)
81
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who have scheduled for laparoscopic cholecystectomy
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-II
- Presumptive diagnosis of benign gallbladder disease
Exclusion Criteria:
- The patients with concurrent chronic disease like osteoporosis, and liver, pulmonary or renal disease, malignant disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study
liver cauterized during laparoscopic cholecystectomy.
|
|
|
Control
liver not-cauterized during laparoscopic cholecystectomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual analog scale (VAS) abdominal pain scores
Time Frame: Postoperative 2nd hour
|
Postoperative 2nd hour
|
|
Visual analog scale (VAS) abdominal pain scores
Time Frame: Postoperative 24th hour
|
Postoperative 24th hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
July 26, 2016
First Submitted That Met QC Criteria
August 1, 2016
First Posted (Estimate)
August 2, 2016
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
August 1, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAP-COL-CAUTER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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