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Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02852408
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Information provided by (Responsible Party):
Fatih Basak, Umraniye Education and Research Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Laparoscopic Cholecystectomy Postoperative Pain Procedure: Laparoscopic cholecystectomy

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.

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Unintentional Liver Cauterization Increases the Postoperative Pain After Laparoscopic Cholecystectomy: A Prospective Controlled Blinded Trial
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Group/Cohort Intervention/treatment
Study
liver cauterized during laparoscopic cholecystectomy.
Procedure: Laparoscopic cholecystectomy
Control
liver not-cauterized during laparoscopic cholecystectomy.
Procedure: Laparoscopic cholecystectomy



Primary Outcome Measures :
  1. Visual analog scale (VAS) abdominal pain scores [ Time Frame: Postoperative 2nd hour ]
  2. Visual analog scale (VAS) abdominal pain scores [ Time Frame: Postoperative 24th hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have scheduled for laparoscopic cholecystectomy
Criteria

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
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Responsible Party: Fatih Basak, Dr., Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02852408    
Other Study ID Numbers: LAP-COL-CAUTER
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms