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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011081
Receipt No. R000012956
Scientific Title Surgical stress, cardiopulmonary and immunologic effect of hybrid natural orfice transluminal endoscopic surgery (NOTES) compared to laparoscopic surgery
Date of disclosure of the study information 2013/07/01
Last modified on 2015/08/03

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Basic information
Public title Surgical stress, cardiopulmonary and immunologic effect of hybrid natural orfice transluminal endoscopic surgery (NOTES) compared to laparoscopic surgery
Acronym Hybrid NOTES, laparoscopic surgery and surgical stress
Scientific Title Surgical stress, cardiopulmonary and immunologic effect of hybrid natural orfice transluminal endoscopic surgery (NOTES) compared to laparoscopic surgery
Scientific Title:Acronym Hybrid NOTES, laparoscopic surgery and surgical stress
Region
Japan

Condition
Condition Gastrointestinal Stromal Tumors of the Stomach.
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the surgical stress and cardiopulmonary and immunologic effects of hybrid NOTES compared with laparoscopic surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immunologic parameters included white blood cell count, tumor necrosis factor-a, interleukin-1B, and interleukin-6 at before and immediately after the operation, post operative day 1, 3 and 5.Surgical stress parameters included blood sugar and cortisol.
Key secondary outcomes Cardiopulmonary parameters included heart rate, blood pressure, saturation pulse oximetry, intratracheal pressure, and arterial blood gases.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Endoscopic and laparoscopic surgery for gastrointestinal stromal tumor in the stomach.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria The patients who have gastric endogastic type of gastrointestinal stromal tumor.Those who signed informed consent.
Key exclusion criteria The patient's exclusion criteria for the present study were as follows: 1) lesions that could not result in en bloc resection 2) severe organ failure; and 3) an inability to obtain informed consent.
Those who are judged unable to withstand surgery by the investigators with the preoperative assessment.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirohito Mori
Organization Kagawa University,Faculty of Medicine
Division name Department of Gastroenterology and Neurology
Zip code
Address 1750-1, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793
TEL +81-87-891-2156
Email hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Mori
Organization Kagawa University,Faculty of Medicine
Division name Department of Gastroenterology and Neurology
Zip code
Address 1750-1, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793
TEL +81-87-891-2156
Homepage URL
Email sannai@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University, Department of Gastroenterology and Neurology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kagawa University, Department of Gastroenterology and Neurology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 07 Month 01 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 Terminated
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 30 Day
Last modified on
2015 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012956


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