Status Approved
First Submitted Date
2020/12/03
Registered Date
2020/12/29
Last Updated Date
2021/09/07
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005714 |
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Unique Protocol ID | SMC 2020-10-058-002 |
Public/Brief Title | Effects of chewing gum during pre-anesthetic fasting on preoperative anxiety and postoperative recovery in patients undergoing laparoscopic gynecological surgery |
Scientific Title | Effects of chewing gum during pre-anesthetic fasting on preoperative anxiety and postoperative recovery in patients undergoing laparoscopic gynecological surgery with ERAS protocol |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | SMC 2020-10-058-002 |
Approval Date | 2020-12-03 |
Institutional Review Board Name | Samsung medical center, institutional review board |
Institutional Review Board Address | 81, Irwon-ro, Gangnam-gu, Seoul |
Institutional Review Board Telephone | 02-3410-2973 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jeongjin MIn |
Title | Assistant professor |
Telephone | +82-2-3410-5257 |
Affiliation | Samsung Medical Center |
Address | (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea |
Contact Person for Public Queries | |
Name | Yujeong Bang |
Title | Clinical fellow |
Telephone | +82-2-3410-6580 |
Affiliation | Samsung Medical Center |
Address | (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea |
Contact Person for Updating Information | |
Name | Yujeong Bang |
Title | Clinical fellow |
Telephone | +82-2-3410-6580 |
Affiliation | Samsung Medical Center |
Address | (06351) 81 Irwon-Ro Gangnam-gu. Seoul, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2021-01-04 Actual | |
Target Number of Participant | 104 | |
Primary Completion Date | 2021-08-13 , Actual | |
Study Completion Date | 2021-08-13 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Samsung Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2021-01-04 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
Project ID | SMC 2020-10-058-001 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | In the case of patients undergoing general anesthesia, fasting of 8 hours of solid food, 6 hours of light meals, and 2 hours of clear drink is strictly followed in accordance with the guidelines of the American Society of Anesthesiology to prevent complications such as regurgitation of gastric juice and pulmonary aspiration. Currently, the concept of early recovery after surgery (ERAS) was introduced for early recovery after surgery in various surgical patients. In accordance with this guideline, a clear liquid should be consumed 2 hours before anesthesia, and carbohydrate beverages should be administered during the fasting period. Oral carbohydrate loading in the preoperative period minimizes the side effects such as catabolic state and delay in recovery due to excessive fasting can be prevented, and promotes the patient's satisfaction and well-being. Oral carbohydrate loading is recommended to administer 800ml to 400ml of carbohydrate beverages up to 2 hours before surgery as a standard practice. The ERAS Society has suggested that chewing gum during the fasting period before surgery also has a positive effect and can be recommended. Studies have recently been published that chewing gum in the preoperative fasting period does not affect gastric volume and acidity in patients before surgery, lowers patient anxiety, and reduces side effects from fasting. We recently conducted study in the gynecologic patients of our hospital that chewing gum during preoperative period has an significant effect in reducing preoperative anxiety and improving postoperative recovery (SMC 2019-05-168-001). Similar to the previous study results, no adverse events were reported. At present, gynecology department of our hospital decided to apply the ERAS protocol to patients who are scheduled to undergo surgery at the gynecological cancer center, and accordingly, they will take a carbohydrate drink during the fasting time before surgery. This study is a serial study (SMC 2019-05-168-001) on the anxiety reduction effect of chewing gum within the preoperative fasting time. Patients participating in the altered treatment protocol of gynecology were set as a control group and the fasting period before surgery. We would like to investigate whether there is an effect of reducing anxiety and discomfort before surgery by additionally performing a sham feeding with chewing gum. In addition, we would like to compare whether there is any difference in recovery of gastrointestinal function, diet resumption, postoperative recovery, and well-being between each group. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Supportive Care |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | ① The patient is assigned to the Experimentand control groups on a random basis on the eve of the operation by independent gynecologist. All patients strictly observes the fast times of eight hours of solid form, six hours of fluid and two hours of clear fluid in a traditional way. ② The patients in the control group (carbohydrate group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO at 5am. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery. ③ The patients in the test group (gum group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery.The test group (Group G) is allowed to chew gum that is distributed freely during fast time, while follow the fasting protocol. ④ There is no intervention other than chewing gum during fast times between the two groups of patients, and subsequent anesthesia and pre-anesthesia examinations will be the same. |
Number of Arms | 2 |
Arm 1 |
Arm Label Carbohydrate group |
Target Number of Participant 52 |
|
Arm Type No intervention |
|
Arm Description The patients in the control group (carbohydrate group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery. |
|
Arm 2 |
Arm Label gum group |
Target Number of Participant 52 |
|
Arm Type No intervention |
|
Arm Description The patients in the test group (gum group) follows the protocols of our gynecologic strategy. Patiens will fast during the times of eight hours of solid form, six hours of fluid and two hours of water in a traditional way. Instead, they drink 2 cans of oral carbohydrate (NO NPO) as their dinner. In the first case of operation day, patients would drink a can of NO NPO at 5am. In other case of operation day morning, patiens would drink a can of NO NPO 3hours prior to surgery. In the other cases of operation day afternoon, patients would drink each can of NO NPO in breakfast time (7 am) and 3hours prior to surgery. The test group (Group G) is allowed to chew gum that is distributed freely during fast time, while follow the fasting protocol. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F41.9)Anxiety disorder, unspecified Test Anxiety Questionnaire Enhanced Recovery After Surgery Recovery Period, Anesthesia Perioperative Period |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 19Year~69Year |
|
Description (1) ASA class I-III adult patient (age 19 and under 70) (2) Patients undergoing the laparoscopic gynecological surgery |
|
Exclusion Criteria |
(1) Pediatric (under 19) (2) Old age (over 69) (2) Pregnant and nursing mothers (3) Patients with unstable vital signs (4) Patients who are at high risk of aspiration persons with a BMI of 30 or more, gastroesophageal reflux, chronic renal failure, oesophageal structures, achalasia, enteropaties, diabets mellitus, and with a history of gastrointestinal tumors; (5) Any medical history that could effect GI motility (6) Patients with liver and kidney disease (6) Emergency surgery. (7) Patients who do not agree to participate in the study |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | Pre-operative anxiety |
|
Timepoint | proir to induction of general anesthesia |
|
Secondary Outcome(s) 1 | ||
Outcome | Symptoms related to anxiety |
|
Timepoint | inhospital period |
|
Secondary Outcome(s) 2 | ||
Outcome | Recovery or bowel function |
|
Timepoint | inhospital period |
|
Secondary Outcome(s) 3 | ||
Outcome | bowel complication |
|
Timepoint | inhospital period |
|
Secondary Outcome(s) 4 | ||
Outcome | Quality of recovery questionnaire ( with QoR 15 score) |
|
Timepoint | inhospital period |
|
Secondary Outcome(s) 5 | ||
Outcome | gastric volume with gastric sonography |
|
Timepoint | inhospital period |
|
Secondary Outcome(s) 6 | ||
Outcome | Gastric fluid volume and acidity |
|
Timepoint | inhospital period |
|
Secondary Outcome(s) 7 | ||
Outcome | intraoperative outcomes |
|
Timepoint | intraoperative period |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2021. 11 |
Way of Sharing | Available on Request
(gagreflex.bang@gmail.com) |
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