UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Functional outcome and late complications after laparoscopically assisted anorectoplasty for male infants with high-type imperforate anus: Multicenter retrospective study
Title of the study (Brief title)	Multicenter study for male infants with high-type imperforate anus
Region	Japan

Condition
Condition	imperforate anus
Classification by specialty	Gastrointestinal surgery Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. Comparison of long-term functional outcome between conventional approach and laparoscopically assisted anorectoplasty for male infants with high-type imperforate anus 2. Review of late complications after laparoscopically assisted anorectoplasty
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative functional outcome Complication rate
Key secondary outcomes

Base
Study type	Observational

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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	Rectourethral fistula (high-type)
Key exclusion criteria	none
Target sample size	100

Research contact person
Name of lead principal investigator	Tadashi Iwanaka
Organization	The University of Tokyo
Division name	Department of Pediatric Surgery
Address	7-3-1, Hongo, Bunkyo, Tokyo
TEL	03-5800-8671
Email	iwanakat-psu@h.u-tokyo.ac.jp

Public contact
Name of contact person	Tetsuya Ishimaru
Organization	The University of Tokyo
Division name	Department of Pediatric Surgery
Address	7-3-1, Hongo, Bunkyo, Tokyo
TEL	03-5800-8671
Homepage URL
Email	i-tetsuya@umin.ac.jp

Sponsor
Institute	Department of Pediatric Surgery, The University of Tokyo
Institute
Department

Funding Source
Organization	The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

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	2010 Year 11 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 28 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry	2012 Year 10 Month 15 Day
Date trial data considered complete	2012 Year 10 Month 15 Day
Date analysis concluded	2012 Year 11 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.ncbi.nlm.nih.gov/pubmed/24314175
Results	Eighty-one patients (conventional: 36, LAARP: 45) were enrolled from 15 centers. In both groups, the mean Kelly score was 5. The total score of the scoring system was newly developed by the Japanese Study Group of Anorectal Anomalies Follow-up Project (5-15 points) was 10.7 and 12.1 in the conventional group and the LAARP group, respectively (p=0.07). The incidence of failed rectoanal anastomosis, mucosal prolapse, and anal stenosis was comparable in both groups. Posterior urethral diverticula were detected on cystourethrograms in 7% and 11% (p=1.0) and on MRI in 0% and 34% (p=0.02) of the conventional and the LAARP groups, respectively. Overall, 94% of diverticula were asymptomatic.
Other related information	retrospective study

Management information
Registered date	2010 Year 11 Month 12 Day
Last modified on	2019 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005435