UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037742
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

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Basic information

Public title

Transsacral endoscopic surgery in the prone Jackkinfe position for pelvic tumors

Acronym

Transsacral (transanal, transperineal, and transsacral) endoscopic surgery in the prone Jackkinfe position

Scientific Title

Transsacral endoscopic surgery in the prone Jackkinfe position for pelvic tumors

Scientific Title:Acronym

Transsacral (transanal, transperineal, and transsacral) endoscopic surgery in the prone Jackkinfe position

Region

Japan


Condition

Condition

Giant pelvic tumor / lower rectal tumor

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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.

Key secondary outcomes

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.


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

Transsacral (transanal, transperineal, and transsacral) endoscopic surgery in the prone Jackkinfe position

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Dai
Middle name
Last name Uematsu

Organization

Saku Central Hospital Advanced Care Center

Division name

Digestive Surgery

Zip code

385-0051

Address

3400-28 Nakagomi, Saku, 385-0051 JAPAN

TEL

0267-62-8181

Email

gorontadu1110@circus.ocn.ne.jp


Public contact

Name of contact person

1st name Miyuki
Middle name
Last name Niimi

Organization

Saku Central Hospital Advanced Care Center

Division name

Clinical Research Center

Zip code

385-0051

Address

3400-28 Nakagomi, Saku, 385-0051 JAPAN

TEL

0267-62-8181

Homepage URL


Email

ctroffice@sakuhp.or.jp


Sponsor or person

Institute

Saku Central Hospital Advanced Care Center

Institute

Department

Personal name



Funding Source

Organization

Saku Central Hospital Advanced Care Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saku Central Hospital Group Research Ethics Committee

Address

197 Usuda, Saku, 384-0301 JAPAN

Tel

0267-82-3131

Email

irboffice@sakuhp.or.jp


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

佐久総合病院 佐久医療センター(長野県)


Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2018 Year 02 Month 10 Day

Date of IRB

2018 Year 03 Month 07 Day

Anticipated trial start date

2018 Year 03 Month 27 Day

Last follow-up date

2023 Year 06 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 20 Day

Last modified on

2023 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043028


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name