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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001314
Receipt No. R000001601
Scientific Title Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Date of disclosure of the study information 2008/08/15
Last modified on 2008/08/15

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Basic information
Public title Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Acronym Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Scientific Title Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Scientific Title:Acronym Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction
Region
Japan

Condition
Condition small bowel obstruction
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Bowel obstruction, which is caused by various diseases, can follow a critical course, such as rupture of the intestine, sepsis, and multi-organ failure, without adequate treatment. A long tube is placed for the purpose of decompression of the obstructed intestine by aspiration of the intestinal contents, leading to favorable outcomes including a decrease in edema, improvement of the circulation of the involved intestine, and correction of intestinal kinking.
Although long-tube insertion is widely used in clinical practice, it is sometimes difficult to intubate the small bowel with a long tube, resulting in long procedure time, severe patient distress, and increased exposure to X-ray when the procedure is performed under fluoroscopy.
We conducted a prospective randomized controlled trial to evaluate a novel technique for long-tube insertion, namely, a ropeway method employing a guidewire, placed by transnasal ultrathin endoscopy, in the treatment of bowel obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the time required by the procedure until the long tube passed through the duodenojejunal flexure in successful cases
Key secondary outcomes the success rate, the total procedure time, the total X-ray exposure time, the intensity of patient distress on a visual analogue scale of 1 to 5, and complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ILTR (Intervention group):
For local anesthesia, application of a nose drop of naphazolone nitrate and spraying of a mixture of 4% lidocain and 0.1% epinephrine solution (9:1) to the nostrils were performed. Diazepam and/or pentazocine were administered as necessary. The scope (GIF-XP260N; Olympus, Tokyo, Japan) was inserted transnasally with the patient in the left lateral decubitus position. For insertion of the long tube, the patient was kept in the supine position. After aspiration of fluid and air in the stomach via its working channel, the scope was advanced to the duodenum. A guidewire (Jagwire, 0.035 inch, 450 cm long; Boston Scientific, U.S.A) was then inserted via the working channel of the scope into the small bowel beyond the duodenojejunal flexure, which was confirmed fluoroscopically. The scope was withdrawn while the guidewire was kept in place. The guidewire was passed through the tip hole of the long tube (Hydrophilic long tube; Create Medic, Tokyo, Japan) to the most distal side hole (4 cm from the tip). In order to reduce patient pain and friction between the tube and its pathway, lidocain jelly was applied to the tube, and the tube with a splinting guidewire (Create Medic, 1.24 mm, 3500 mm-long) was gently inserted into the naris. When the tube reached the small intestine, the guidewire for guidance was removed and the tube was advanced as anally as possible to the dilated bowel with postural change of the patient and transabdominal manipulation. Finally, the positioning balloon was inflated and the splinting guidewire was withdrawn.
Interventions/Control_2 Conventional long-tube insertion under fluoroscopy (Control group):
In the conventional method, a long tube was inserted under fluoroscopic guidance without endoscopy. When intubation of the small bowel was unsuccessful even with postural change of the patient and transabdominal manipulations, a conventional endoscope for esophagogastroduodenoscopy was inserted perorally to facilitate passage of the tube through the pylorus. Insertion of the tube as deep as possible was attempted even after it had reached the duodenojejunal flexure.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who had been diagnosed as suffering from bowel obstruction requiring decompression with a long tube placement
Key exclusion criteria (1) those who had undergone previous gastrectomy, (2) those with contraindications for placement of a long tube such as previous otorhinolaryngological or esophageal diseases, (3) class IV patients as defined by the American Society of Anesthesiologists, (4) pregnant patients, (5) those younger than 18 years of age, and (6) those with a possible risk of aspiration during the procedure.
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL 022-252-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Kanno
Organization Sendai City Medical Center
Division name Department of Gastroenterology
Zip code
Address 5-22-1, Tsurugaya, Miyagino-ku, Sendai 983-0824, Japan
TEL 022-252-1111
Homepage URL
Email

Sponsor
Institute Sendai City Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 08 Month 15 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
The mean (+/- SD) duration of the procedure in the successful cases in the ILTR group and the C group was 16.1 +/- 5.6 minutes and 26.4 +/- 13.8 minutes, respectively (P = 0.010). The success rate was 100% in the ILTR group and 88% in the C group (P = 0.48). The mean X-ray exposure time and intensity of patient distress were 16.4 +/- 8.7 minutes vs. 33.2 +/- 12.3 minutes (P < 0.001) and 2.6 +/- 0.7 vs. 3.7 +/- 1.2 (P = 0.016), respectively. 
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
2007 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2008 Year 05 Month 01 Day
Date of closure to data entry
2008 Year 05 Month 01 Day
Date trial data considered complete
2008 Year 06 Month 01 Day
Date analysis concluded
2008 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 15 Day
Last modified on
2008 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001601

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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