Cholelithiasis, Chronic Cholecystitis
Conditions
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.
Interventions
DRUGVitamin 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.
DRUGPlacebo
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.
Sponsors
Taeho Hong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The postoperative pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity | 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. |
Countries
South Korea
Contacts
Primary ContactTaeho Hong
Outcome results
None listed