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

Small Bowel Obstruction Clinical Trial

— COTACSO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03139149
• Other study ID #: 14121729
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Pirogov Russian National Research Medical University
• Contact: Alexander E Tyagunov, MD. Prof
• Phone: +79165022324
• Email: tyagunov1[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients with adhesive small bowel obstruction

Exclusion Criteria:

Early postoperative small bowel obstruction Irreducible hernia Strangulation or peritonitis symptoms Impairment of consciousness Unstable hemodynamics

Related Conditions & MeSH terms

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

Intervention

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.
• 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

Locations

Country	Name	City	State
Russian Federation	Moscow Clinical Hospital 1	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of patients with obstruction release after conservative treatment	No of patients with success of conservative treatment	in the 2nd group - 48 hours
Secondary	Readmission rate in conservative treatment and surgery	12 months readmission rate	12 months
Secondary	30 days mortality	Number of patients who has dead in 30 days after admission	30 days
Secondary	Complications rate	Number of complications rate in groups	30 days
Secondary	Quantity of bowel resection	Number of patients who undergo bowel resection in groups	156 hours