NCT02553551

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

September 13, 2015

Last Update Submit

October 17, 2016

Conditions

Chronic CholecystitisCholelithiasis

Outcome Measures

Primary Outcomes (1)

  • 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.

    The change of pain score between 6hours after operation and 24hours after operation

Secondary Outcomes (1)

  • Postoperative morbidity

    30 days

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Vitamin CDRUG

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.

Also known as: Vitamin
Vitamin C
PlaceboDRUG

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.

Also known as: placebo capsule
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic cholecystitis
  • gallbladder polyp

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of HBP Surgery, Seoul St. Mary's hospital

Seoul, Seocho-gu, Banopo-dong, 137-701, South Korea

RECRUITING

MeSH Terms

Conditions

Cholelithiasis

Interventions

Ascorbic AcidVitamins

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesMicronutrientsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesNutrientsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Taeho Hong

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taeho Hong

CONTACT

821052065266gshth@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2015

First Posted

September 17, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations

KR(1)