NCT03139149

Comparison of Early Operative Treatment and 48 h Conservative Treatment in Small Bowel Obstruction

Comparison of Early Operative Treatment (12 h) and 48 h Conservative Treatment in Acute Small Bowel Obstruction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 17 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the results of early surgery after 12 h conservative treatment and 48 h conservative treatment of adhesive small bowel obstruction.

Detailed description

At the admission patients undergo abdomen x-ray, general and biochemical blood test and computer tomography (CT). After exclusion of indications for an emergency operation, patients are given a water-soluble contrast. Conservative treatment is carring out to 12 hours from admission. All patients with resolution of small bowel obstruction in 12 hours will be excluded from the research. Criteria for obstruction release of conservative treatment 1. No pain 2. Appearance of gas in the colon 3. Decrease of bloating 4. Contrast in the colon. After that, if obstruction is not resolved, randomization is performed. First group undergo surgery. Second group undergo conservative treatment with water-soluble contrast evaluation until 48 hours. In the second group surgery is performed if the conservative treatment is not effective. The results of early and late surgery and the results of conservative treatment in groups will be compared.

Conditions

• Small Bowel Obstruction
• Small Bowel Adhesion
• Strangulation of Ileum

Interventions

Type	Name	Description
PROCEDURE	Adhesiolysis	Method of video laparoscopic operation: * Open access in the left upper quadrant of the anterior abdominal wall, * Installation of trocars, depending on the prevalence of the adhesion process * Assessment of the peritoneal adhesion index * Detection of the asleep gut * Detection of obstacle area * Removing the obstacle without trying to completely eliminate the adhesion process in the abdominal cavity If there is no possibility to eliminate the cause of intestinal obstruction laparoscopically laparotomy is performed.
RADIATION	X-ray diagnostics	X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.
RADIATION	Computer tomography	Computer tomography of abdomen with iv contrast
PROCEDURE	Ultrasound	Ultrasound of the abdomen (2 times)
OTHER	General and biochemical blood test	General blood test and biochemical blood test 2 times a day

Timeline

• Start date: 2017-10-11
• Primary completion: 2024-04-30
• Completion: 2024-12-31
• First posted: 2017-05-03
• Last updated: 2023-03-30

Locations

1 site across 1 country: Russia