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Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

Primary Purpose

Chronic Cholecystitis, Cholelithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vitamin C
Placebo
Sponsored by
Taeho Hong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cholecystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of HBP Surgery, Seoul St. Mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin C

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2015
Last Updated
October 17, 2016
Sponsor
Taeho Hong
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1. Study Identification

Unique Protocol Identification Number
NCT02553551
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Taeho Hong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cholecystitis, Cholelithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Vitamin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo capsule
Intervention Description
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.
Primary Outcome Measure Information:
Title
The postoperative pain
Description
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.
Time Frame
The change of pain score between 6hours after operation and 24hours after operation
Secondary Outcome Measure Information:
Title
Postoperative morbidity
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taeho Hong
Phone
821052065266
Email
gshth@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taeho Hong
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of HBP Surgery, Seoul St. Mary's hospital
City
Seoul
State/Province
Seocho-gu, Banopo-dong
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taeho Hong
Phone
+82-2-2258-6108
Email
gshth@catholic.ac.kr

12. IPD Sharing Statement

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Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy

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