Chronic CholecystitisNCT02553551
Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy
A study testing Vitamin C in people with Chronic Cholecystitis and Cholelithiasis, run by Taeho Hong at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Cholecystitis, Cholelithiasis
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic cholecystitis
- gallbladder polyp
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of HBP Surgery, Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, 137-701
Taeho Hong, +82-2-2258-6108, gshth@catholic.ac.kr
About this study
Official title: Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Cholecystitis, Cholelithiasis
- Being tested
- Vitamin C, Placebo
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Vitamin
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.
PlaceboDrug
Also called placebo capsule
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.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | 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. Receives: Drug: Vitamin C |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative pain
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.
Measured: The change of pain score between 6hours after operation and 24hours after operation
Secondary outcomes (1)
Postoperative morbidity
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taeho Hong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taeho Hong, Seoul St. Mary's Hospital
- Investigators
- Taeho Hong, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553551
- Sponsor's protocol ID
- Seoul-06
- Status last verified
- Oct 2016
- First submitted
- 13 Sep 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02553551
- Acronym / sponsor ID
- Seoul-06
- Conditions
- Chronic Cholecystitis, Cholelithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Taeho HongUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin CDuring 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. |
| Placebo | Placebo comparator | Drug: PlaceboDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic cholecystitis
- gallbladder polyp
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: VitaminDuring 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 |
| PlaceboAlso: placebo capsuleDuring 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 |
Primary outcome
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.
1 secondary outcome
Postoperative morbidity
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taeho Hong principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Chronic Cholecystitis and Cholelithiasis, run by Taeho Hong at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taeho Hong (821052065266, gshth@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative pain (time frame: The change of pain score between 6hours after operation and 24hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.