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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031802
Receipt No. R000036303
Scientific Title The effect of different levels of elevated artificial pneumoperitoneum pressure on the cerebral perfusion pressure during laparoscopic-cholycystectomy.
Date of disclosure of the study information 2018/04/01
Last modified on 2018/03/19

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Basic information
Public title The effect of different levels of elevated artificial pneumoperitoneum pressure on the cerebral perfusion pressure during laparoscopic-cholycystectomy.
Acronym The effect of different levels of elevated artificial pneumoperitoneum pressure on the cerebral perfusion pressure during laparoscopic-cholycystectomy.
Scientific Title The effect of different levels of elevated artificial pneumoperitoneum pressure on the cerebral perfusion pressure during laparoscopic-cholycystectomy.
Scientific Title:Acronym The effect of different levels of elevated artificial pneumoperitoneum pressure on the cerebral perfusion pressure during laparoscopic-cholycystectomy.
Region
Africa

Condition
Condition double blinded comparative study
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 improve the safety of the introduction of the first trocar and investigate the changes in cerebral perfusion pressure and cerebral oxygen extraction caused by high transient pneumo-peritoneum pressures for short periods of time
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase IV

Assessment
Primary outcomes Determine the range of safety of inflation of intrapretoneal pressure on cerebral perfusion pressure
Key secondary outcomes Improve the outcome after laparoscopic surgery.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 inflating the peritoneal cavity up to 20mmHg
Interventions/Control_2 Inflating the peritoneal cavity up to 12mmHg
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
20 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria 1- elective laparoscopic cholycystectomy
2- ASA I or ASA II
3- between 20 and 45 years
4- no history of abdominal surgery on organs
5- body mass index less than 35
Key exclusion criteria 1- history of smoking
2- cardiovascular, respiratory, neurologic,
renal, liver, or hormonal disease
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name HANI I TAMAN
Organization MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
Division name ANAESTHESIOLOGY DEPARTMENT
Zip code
Address 12, ELGOMHORIA STREET, MANSOURA, EGYPT
TEL 020502261333
Email mfm@mans.edu.eg

Public contact
Name of contact person
1st name
Middle name
Last name HANI IBRAHIM TAMAN
Organization MANSOURA FACULTY OF MEDICINE
Division name ANAESTHESIOLOGY DEPARTMENT
Zip code
Address 23 GEHAN STREET, MANSOURA, EGYPT
TEL 020507484774
Homepage URL
Email hani_taman@yahoo.com

Sponsor
Institute MANSOURA FACULTY OF MEDICINE, MANSOURA, EGYPT
Institute
Department

Funding Source
Organization MANSOURA FACULTY OF MEDICINE
Organization
Division
Category of Funding Organization Outside Japan
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
2018 Year 04 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 Completed
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 03 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
2018 Year 03 Month 19 Day
Last modified on
2018 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036303

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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