UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021404
Receipt number 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 23:30:33

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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 or person

Institute

Department of Surgery
Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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