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Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02553551
Recruitment Status : Unknown
Verified October 2016 by Taeho Hong, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : September 17, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Taeho Hong, Seoul St. Mary's Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Cholecystitis Cholelithiasis Drug: Vitamin C Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial
Study Start Date : July 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Vitamin C

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.

Drug: Vitamin C

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.

Other Name: Vitamin

Placebo Comparator: Placebo

During the period of hospitalization, Intake of gelatinous capsule three times per day via oral route until the day of discharge.

After discharge, no additional capsule was given.

Drug: Placebo

During the period of hospitalization, Intake of gelatinous capsule three times per day via oral route until the day of discharge.

After discharge, no additional capsule was given.

Other Name: placebo capsule




Primary Outcome Measures :
  1. The postoperative pain [ Time Frame: The change of pain score between 6hours after operation and 24hours after operation ]
    Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.


Secondary Outcome Measures :
  1. Postoperative morbidity [ Time Frame: 30 days ]
    the incidence of complications after surgery during one month after surgery such as postoperative fever, atelectasis, infectious complications, bile leak, postoperative bleeding, readmission or mortality.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553551


Contacts
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Contact: Taeho Hong 821052065266 gshth@catholic.ac.kr

Locations
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Korea, Republic of
Department of HBP Surgery, Seoul St. Mary's hospital Recruiting
Seoul, Seocho-gu, Banopo-dong, Korea, Republic of, 137-701
Contact: Taeho Hong    +82-2-2258-6108    gshth@catholic.ac.kr   
Sponsors and Collaborators
Taeho Hong
Investigators
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Principal Investigator: Taeho Hong Seoul St. Mary's Hospital

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Responsible Party: Taeho Hong, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02553551     History of Changes
Other Study ID Numbers: Seoul-06
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Calculi
Pathological Conditions, Anatomical
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents