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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021404
Receipt No. R000024688
Scientific Title Clinical trial of laparoscopic surgery using transvaginal ports
Date of disclosure of the study information 2016/03/09
Last modified on 2018/09/18

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Basic information
Public title Clinical trial of laparoscopic surgery using transvaginal ports
Acronym Laparoscopic sugery using TV ports
Scientific Title Clinical trial of laparoscopic surgery using transvaginal ports
Scientific Title:Acronym Laparoscopic sugery using TV ports
Region
Japan

Condition
Condition Gallbladder diseases, SMT of the stomach, acute appendicitis and abdominal diseases
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Natural Orifice Translumenal Endoscopic Surgery (NOTES) was introduced by A. N. Kalloo in 2004. G. V. Rao and D. N. Reddy performed NOTES appendectomy for the first time in 2005. Since then, many cases of NOTES are reported. Transvaginal (TV) hybrid approach is considered to be safe and feasible in many clinical settings although pure NOTES is technically difficult. The purpose of this clinical study is to clarify the safety and feasibility of TV hybrid NOTES procedures in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes Safety: complications (including bleeding, ileus, injury to organs, vaginal bleeding and infection)
Feasibility: pain, postoperative stay
Key secondary outcomes Surgeons' fatigue

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Laparoscopic surgery using transvaginal (TV) ports
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
50 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Menoposal female
2. Patients with diseases and procedures listed below:
a. Gallbladder diseases - laparoscopic cholecystectomy
b. Gastric submucosal tumor - laparoscopic wedge resection of the stomach
c. Acute appendicitis - laparoscopic appendectomy
d. Abdominal diseases - laparoscopic biopsy
e. Other abdominal diseas - Simple laparoscopic procedures
3. Good for general anesthesia
4. Written informed consent
Key exclusion criteria 1. Past history of abdominal surgery
2. Past history of pelvic inflammatory or oncological diseases
3. Uncontrolled vaginal disease
4. Extrem Obesity or emaciation
5. Other reasons of exclusion
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihito Wada
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email nori-kkr@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihito Wada
Organization Keio University School of Medicine
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL http://keiosurg.net/
Email nori-kkr@umin.ac.jp

Sponsor
Institute Department of Surgery
Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery
Keio University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 慶應義塾大学病院(東京都)Keio University Hospital, Tokyo, Japan

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results A patient with cholecystolithiasis was treated with hybrid transvaginal cholecystectomy
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
2011 Year 05 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 13 Day
Last follow-up date
2017 Year 06 Month 07 Day
Date of closure to data entry
2017 Year 06 Month 07 Day
Date trial data considered complete
2017 Year 06 Month 07 Day
Date analysis concluded
2017 Year 06 Month 07 Day

Other
Other related information Wada N, Tanabe M, Kataoka F, Kitagawa Y. Transvaginal hybrid natural orifice translumenal endoscopic surgery appendectomy. Nihon Geka Gakkai Zasshi 114(6): 308-311, 2013

Management information
Registered date
2016 Year 03 Month 09 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024688

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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