Evidence of CholecystectomyPhase 3laparoscopyNCT02555020
Effect of Preoperative Oral Carbohydrates on Quality of Recovery
A Phase 3 study testing Allocated to Carbohydrated group and Allocated to MN NPO group, in people with Evidence of Cholecystectomy, run by Yonsei University.
Trial summary
Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Evidence of Cholecystectomy
- What is being tested?
- Allocated to Carbohydrated group and Allocated to MN NPO group,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to 23 Dec 2016
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (I/II)
- Laparoscopic cholecystectomy.
- KAROFSKY PERFORMANCE SCALE >70,
- No history of major operation
Who cannot join
- DM patients
- GE reflux Hx patients.
- No- compliance,
- Previous Abdominal Surgery History
About this study
Official title: Effect of Preoperative Oral Carbohydrates on Quality of Recovery: Randomized Controlled Trial
Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.
Read the detailed description
Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
- Conditions
- Evidence of Cholecystectomy
- Being tested
- Allocated to Carbohydrated group, Allocated to Placebo group, Allocated to MN NPO group,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allocated to Carbohydrated groupDietary supplement
Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
Allocated to Placebo groupDietary supplement
Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.
Allocated to MN NPO group,Dietary supplement
Patients received NPO from MN.
| Study group | Role | What they receive |
|---|---|---|
| Allocated to MN NPO group, | Experimental | 1. Patients was administered in hospital
2. Randomization
3. Patient was allocated to MN group
4. Patients were NPO from mid night (MN) to Surgery Receives: Dietary Supplement: Allocated to MN NPO group, |
| Allocated to Placebo group | Placebo comparator | 1. Patients was administered in hospital
2. Randomization
3. Patient was allocated to Placebo group
4. Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia. Receives: Dietary Supplement: Allocated to Placebo group |
| Allocated to Carbohydrated group | Active comparator | 1. Patients was administered in hospital
2. Randomization
3. Patient was allocated to Carbohydrated group
4. Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal. Receives: Dietary Supplement: Allocated to Carbohydrated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery score using the QoR-40 Questionnaire
We check the QoR-40 Questionnaire at discharge day
Measured: We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion22 Dec 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evidence of CholecystectomyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Seong Park, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555020
- Sponsor's protocol ID
- 3-2015-0158
- Acronym
- laparoscopy
- Status last verified
- Sep 2017
- First submitted
- 11 Sep 2015
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee JS, Song Y, Kim JY, Park JS, Yoon DS. Effects of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Cholecystectomy: A Randomized, Double Blind, Placebo-Controlled Trial. World J Surg. 2018 Oct;42(10):3150-3157. doi: 10.1007/s00268-018-4717-4.
PubMed 29915988
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Carbohydrates on Quality of Recovery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02555020
- Acronym / sponsor ID
- laparoscopy / 3-2015-0158
- Conditions
- Evidence of Cholecystectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 21 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.
Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.
Detailed description
Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allocated to MN NPO group, | Experimental | Dietary Supplement: Allocated to MN NPO group,1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to MN group 4. Patients were NPO from mid night (MN) to Surgery |
| Allocated to Placebo group | Placebo comparator | Dietary Supplement: Allocated to Placebo group1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to Placebo group 4. Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia. |
| Allocated to Carbohydrated group | Active comparator | Dietary Supplement: Allocated to Carbohydrated group1. Patients was administered in hospital 2. Randomization 3. Patient was allocated to Carbohydrated group 4. Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA (I/II)
- Laparoscopic cholecystectomy.
- KAROFSKY PERFORMANCE SCALE >70,
- No history of major operation
Key exclusion criteria (4 listed)
- DM patients
- GE reflux Hx patients.
- No- compliance,
- Previous Abdominal Surgery History
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 |
|---|---|---|
| Allocated to Carbohydrated groupPatients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal. | Dietary supplement | Allocated to Carbohydrated group |
| Allocated to Placebo groupPatients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before. | Dietary supplement | Allocated to Placebo group |
| Allocated to MN NPO group,Patients received NPO from MN. | Dietary supplement | Allocated to MN NPO group, |
Primary outcome
Quality of Recovery score using the QoR-40 Questionnaire
Time frame: We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days
We check the QoR-40 Questionnaire at discharge day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 29915988Lee JS, Song Y, Kim JY, Park JS, Yoon DS. Effects of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Cholecystectomy: A Randomized, Double Blind, Placebo-Controlled Trial. World J Surg. 2018 Oct;42(10):3150-3157. doi: 10.1007/s00268-018-4717-4.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allocated to Carbohydrated group and Allocated to MN NPO group, in people with Evidence of Cholecystectomy, run by Yonsei University.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery score using the QoR-40 Questionnaire (time frame: We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02555020, which also lists 1 linked publication.
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 Sep 2017.