Unique ID issued by UMIN | UMIN000021404 |
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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 |
Clinical trial of laparoscopic surgery using transvaginal ports
Laparoscopic sugery using TV ports
Clinical trial of laparoscopic surgery using transvaginal ports
Laparoscopic sugery using TV ports
Japan |
Gallbladder diseases, SMT of the stomach, acute appendicitis and abdominal diseases
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Others
NO
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.
Safety,Efficacy
Confirmatory
Explanatory
Phase IV
Safety: complications (including bleeding, ileus, injury to organs, vaginal bleeding and infection)
Feasibility: pain, postoperative stay
Surgeons' fatigue
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Laparoscopic surgery using transvaginal (TV) ports
50 | years-old | <= |
Not applicable |
Female
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
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
100
1st name | |
Middle name | |
Last name | Norihito Wada |
Keio University School of Medicine
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-1211
nori-kkr@umin.ac.jp
1st name | |
Middle name | |
Last name | Norihito Wada |
Keio University School of Medicine
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
03-3353-1211
http://keiosurg.net/
nori-kkr@umin.ac.jp
Department of Surgery
Keio University School of Medicine
Department of Surgery
Keio University School of Medicine
Self funding
Japan
None
None
NO
慶應義塾大学病院(東京都)Keio University Hospital, Tokyo, Japan
2016 | Year | 03 | Month | 09 | Day |
Published
A patient with cholecystolithiasis was treated with hybrid transvaginal cholecystectomy
Completed
2011 | Year | 05 | Month | 13 | Day |
2011 | Year | 05 | Month | 13 | Day |
2017 | Year | 06 | Month | 07 | Day |
2017 | Year | 06 | Month | 07 | Day |
2017 | Year | 06 | Month | 07 | Day |
2017 | Year | 06 | Month | 07 | Day |
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
2016 | Year | 03 | Month | 09 | Day |
2018 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024688
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