Unique ID issued by UMIN | UMIN000037742 |
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Receipt number | R000043028 |
Scientific Title | Transsacral endoscopic surgery in the prone Jackkinfe position for pelvic tumors |
Date of disclosure of the study information | 2019/08/21 |
Last modified on | 2023/09/25 09:38:10 |
Transsacral endoscopic surgery in the prone Jackkinfe position for pelvic tumors
Transsacral (transanal, transperineal, and transsacral) endoscopic surgery in the prone Jackkinfe position
Transsacral endoscopic surgery in the prone Jackkinfe position for pelvic tumors
Transsacral (transanal, transperineal, and transsacral) endoscopic surgery in the prone Jackkinfe position
Japan |
Giant pelvic tumor / lower rectal tumor
Gastrointestinal surgery |
Malignancy
NO
We are going to perform transanal, transperineal, and transsacral endoscopic surgery (TSES) for the rectal tumor located below the 4th sacrum, the lower rectal cancer located within about 6cm from the anal verge, and the giant pelvic tumor to achieve the proper surgical field and further improvement in manipulation. We verify the safety and the oncological usefulness of TSES.
Safety,Efficacy
Surgical bleeding and surgical time as the safety criteria, surgical resected margin of the specimen and accidental perforation of the rectum during the surgery as the oncological criteria.
Post-surgical complications including pelvic wound infection, wound dehiscence, pelvic abscess, urinary infection, and intestinal paralysis, and 3-year local recurrence rate, 3-year overall survival rate, and 3-year disease free survival rate.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Transsacral (transanal, transperineal, and transsacral) endoscopic surgery in the prone Jackkinfe position
Not applicable |
Not applicable |
Male and Female
1) The male patients with the rectal tumor located below the 4th sacrum, the lower rectal cancer located within about 6cm from the anal verge, and the giant pelvic tumor embedded in the pelvis.
2) The patients who agreed the entry of this study of their own free will in writing by a principal or a substitute after they had comprehended it well by enough explanation.
1) The male patiets with the pelvic tumor, which are adapted for the anterior approach and TaTME or TpTME in the lithotomy-Trendelenburg position.
2)The patients who are inappropriate as the subjects of this study by the corresponding doctor are excluded.
60
1st name | Dai |
Middle name | |
Last name | Uematsu |
Saku Central Hospital Advanced Care Center
Digestive Surgery
385-0051
3400-28 Nakagomi, Saku, 385-0051 JAPAN
0267-62-8181
gorontadu1110@circus.ocn.ne.jp
1st name | Miyuki |
Middle name | |
Last name | Niimi |
Saku Central Hospital Advanced Care Center
Clinical Research Center
385-0051
3400-28 Nakagomi, Saku, 385-0051 JAPAN
0267-62-8181
ctroffice@sakuhp.or.jp
Saku Central Hospital Advanced Care Center
Saku Central Hospital Advanced Care Center
Self funding
Saku Central Hospital Group Research Ethics Committee
197 Usuda, Saku, 384-0301 JAPAN
0267-82-3131
irboffice@sakuhp.or.jp
NO
佐久総合病院 佐久医療センター(長野県)
2019 | Year | 08 | Month | 21 | Day |
Unpublished
Completed
2018 | Year | 02 | Month | 10 | Day |
2018 | Year | 03 | Month | 07 | Day |
2018 | Year | 03 | Month | 27 | Day |
2023 | Year | 06 | Month | 13 | Day |
2019 | Year | 08 | Month | 20 | Day |
2023 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043028
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