UMIN-CTR Clinical Trial

Basic information
Public title	Total laparoscopic surgery for the treatment of leiomyoma of the transverse colon in a patient with an abdominal mesh: A case report
Acronym	Total laparoscopic surgery for the treatment of leiomyoma of the transverse colon in a patient with an abdominal mesh: A case report
Scientific Title	Total laparoscopic surgery for the treatment of leiomyoma of the transverse colon in a patient with an abdominal mesh: A case report
Scientific Title:Acronym	Total laparoscopic surgery for the treatment of leiomyoma of the transverse colon in a patient with an abdominal mesh: A case report
Region	Japan

Condition
Condition	leiomyoma of the transverse colon
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To present a case in which we applied laparoscopic colectomy with intraabdominal anastomosis for the treatment of leiomyoma of the transverse colon in a patient with an abdominal mesh.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative mesh infection and anastomotic leakage
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	64 years-old <=
Age-upper limit	64 years-old >=
Gender	Female
Key inclusion criteria	A case report of the patient who underwent the surgery
Key exclusion criteria	A case report
Target sample size	1

Research contact person
Name of lead principal investigator	1st name Goshi Middle name Last name Fujimoto
Organization	Ofuna Chuo Hospital
Division name	Gastroenterological surgery
Zip code	247-0056
Address	6-2-24, Ofuna, Kamakura, Kanagawa, Japan
TEL	09021690887
Email	g_chimera_7@yahoo.co.jp

Public contact
Name of contact person	1st name Goshi Middle name Last name Fujimoto
Organization	Ofuna Chuo Hospital
Division name	Gastroenterological surgery
Zip code	247-0056
Address	6-2-24, Ofuna, Kamakura, Kanagawa 247-0056, Japan
TEL	09021690887
Homepage URL
Email	g_chimera_7@yahoo.co.jp

Sponsor
Institute	Ofuna Chuo Hospital
Institute
Department

Funding Source
Organization	Not applicable
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ofuna Chuo Hospital
Address	6-2-24, Ofuna, Kamakura, Kanagawa 247-0056, Japan
Tel	0467-45-2111
Email	jimu@ofnachuohp.net

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

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 03 Day

Related information
URL releasing protocol	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6796651/pdf/main.pdf
Publication of results	Unpublished

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6796651/pdf/main.pdf
Number of participants that the trial has enrolled	1
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 12 Month 11 Day
Date of IRB	2019 Year 07 Month 22 Day
Anticipated trial start date	2018 Year 12 Month 12 Day
Last follow-up date	2019 Year 09 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Not applicable

Management information
Registered date	2019 Year 09 Month 03 Day
Last modified on	2020 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043210