Randomized control trial on long-intestinal-tube insertion with the ropeway method facilitated by a guidewire placed by transnasal ultrathin endoscopy for bowel obstruction

UMIN ID: UMIN000001314

Registered date:15/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: small bowel obstruction
• Date of first enrollment: 2008/05/01
• Target sample size: 34
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 The scope was withdrawn while the guidewire was kept in place.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 Finally, the positioning balloon was inflated and the splinting guidewire was withdrawn.
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.

Outcome(s)

• Primary Outcome: the time required by the procedure until the long tube passed through the duodenojejunal flexure in successful cases
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Sendai City Medical Center
• Secondary Sponsor: single center
• Source(s) of Monetary Support: None