UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of laparoscopic surgery using transvaginal ports
Title of the study (Brief title)	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	Norihito Wada
Organization	Keio University School of Medicine
Division name	Department of Surgery
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	Norihito Wada
Organization	Keio University School of Medicine
Division name	Department of Surgery
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	A patient with cholecystolithiasis was treated with hybrid transvaginal cholecystectomy
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/icdr_e/ctr_view.cgi?recptno=R000024688