Brief Title
Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy
Official Title
Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial
Brief Summary
The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.
Detailed Description
The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial. The primary purpose of this study is to confirm the reduce of postoperative pain through the oral supplement of Vitamine C before and after the surgery. For this purpose, we compared the dosage or counts of opioids usage with the oral supplement of Vitamine C or not. The secondary purpose is to assess the pain score, postoperative morbidities, postoperative length of stay or postoperative time between two groups.
Study Type
Interventional
Primary Outcome
The postoperative pain
Secondary Outcome
Postoperative morbidity
Condition
Chronic Cholecystitis
Intervention
Vitamin C
Study Arms / Comparison Groups
Vitamin C
Description: During the period of hospitalization, Intake of vitamin C 3000 mg per day via oral route until the day of discharge. After discharge, no additional vitamin C pill was given.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
320
Start Date
July 2015
Completion Date
September 2017
Primary Completion Date
September 2017
Eligibility Criteria
Inclusion Criteria: - chronic cholecystitis - gallbladder polyp Exclusion Criteria: - grade I Tokyo guideline for acute cholecystitis - grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation - gallbladder cancer - the patient who underwent reduced port surgery - the patient who underwent common bile duct exploration during the operation - the patient who underwent concurrent operation - the patient who had past history of upper abdominal surgery - the patient who had a immunodeficiency state - the case which had a suspicion of delayed bile leakage - the case which had a incomplete cystic duct ligation - the patient who underwent open conversion surgery during the operation - the patient who had a high risk of bleeding
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Taeho Hong, 821052065266, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02553551
Organization ID
Seoul-06
Responsible Party
Sponsor-Investigator
Study Sponsor
Taeho Hong
Study Sponsor
Taeho Hong, Principal Investigator, Seoul St. Mary's Hospital
Verification Date
October 2016