UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053761 |
|---|---|
| Receipt number | R000061351 |
| Scientific Title | Relationship between Gastric Tube Insertion and Surgical Time in Laparoscopic Cholecystectomy: A Historical Cohort Study |
| Date of disclosure of the study information | 2024/03/04 |
| Last modified on | 2024/03/02 23:56:27 |
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Basic information
Public title
Relationship between Gastric Tube Insertion and Surgical Time in Laparoscopic Cholecystectomy: A Historical Cohort Study
Acronym
Relationship between Gastric Tube Insertion and Surgical Time in Laparoscopic Cholecystectomy: A Historical Cohort Study
Scientific Title
Relationship between Gastric Tube Insertion and Surgical Time in Laparoscopic Cholecystectomy: A Historical Cohort Study
Scientific Title:Acronym
Relationship between Gastric Tube Insertion and Surgical Time in Laparoscopic Cholecystectomy: A Historical Cohort Study
Region
| Japan |
Condition
Condition
cholelithiasis, cholecystitis, gallbladder tumor
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Laparoscopic cholecystectomy is a commonly used minimally invasive surgical procedure for removing the gallbladder. However, visibility can sometimes be impaired due to the proximity of the stomach. To enhance visualization, gastric tubes are occasionally inserted. Previous research has primarily focused on respiratory complications and postoperative nausea and vomiting. However, our study aimed to investigate whether gastric tube insertion affects surgical ease. Specifically, we sought to determine whether gastric tube insertion affects surgery time. If gastric tube insertion does not affect surgery time, it may not be necessary due to the potential risks involved. In conclusion, our study aims to determine whether the use of gastric tubes during laparoscopic cholecystectomy affects surgical ease, with a focus on surgery time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The duration from the beginning to just before the suturing process is referred to as the definition.
Key secondary outcomes
1. Switching to open surgery
2. The frequency of repeat surgeries
3. The duration of postoperative hospital stay, where the day of surgery is considered as day 0
4. Postoperative pharyngeal pain experience
5. Postoperative nausea and vomiting occurrence
6. The length of time under anesthesia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were 18 years or older and underwent laparoscopic cholecystectomy from April 1, 2015, to March 31, 2022, are included in this study. It should be noted that cholecystectomy is not commonly performed on children, but rather on adults.
Key exclusion criteria
1. Patients who have undergone other surgeries, besides cholecystectomy, and have been registered on the same day for laparoscopic cholecystectomy by DPC code due to the increased uncertainty associated with such cases.
2. Patients who have undergone previous or total gastrectomy, as this information is verifiable through their surgical history since there was either no stomach or minimal stomach tissue remaining after the procedure, the term "total gastrectomy" or "gastrectomy" is applicable.
3. Patients who have undergone surgery using a single port are usually excluded from our analysis because the use of a single port significantly restricts the field of view during surgery compared to using multiple ports. It is worth noting that the number of surgeons at our hospital who utilize this technique is quite limited.
4. Patients who had epidural catheter insertion, because we anticipate a high degree of surgical difficulty.
5. Patients with end-stage kidney disease due to uncertainties in delayed drug discharge and systemic status
6. Patients who had histories of laparotomy because we anticipate a high degree of surgical difficulty.
7. Those who have offered their refusal to participate in the study
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | TOKO |
| Middle name | |
| Last name | FUKUSHIMA |
Organization
The Jikei University Katsushika medical center
Division name
Department of Anestheisology
Zip code
105-8471
Address
6-41-2 Aoto Katsushika-ku Tokyo-to Japan
TEL
0334331111
j.toko.fukushima105@gmail.com
Public contact
Name of contact person
| 1st name | Toko |
| Middle name | |
| Last name | Fukushima |
Organization
The Jikei University Katsushika medical center
Division name
Department of Anestheisology
Zip code
125-0061
Address
6-41-2 Aoto Katsushika-ku Tokyo-to Japan
TEL
0336032111
Homepage URL
j.toko.fukushima105@gmail.com
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
TOKO FUKUSHIMA
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of The Jikei University School of Medicine for Biomedical Research Institution
Address
3-25-8 Nishishinbashi, Minato City, Tokyo
Tel
0334331111
j.toko.fukushima105@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2024 | Year | 03 | Month | 02 | Day |
Last modified on
| 2024 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061351
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