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

Pirogov Russian National Research Medical University

Status: Enrolling

Conditions: Small Bowel Obstruction; Small Bowel Adhesion; Strangulation of Ileum

Treatments: Other: General and biochemical blood test; Procedure: Adhesiolysis; Radiation: X-ray diagnostics; Radiation: Computer tomography; Procedure: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03139149

14121729

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 17 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Early surgery

Active Comparator group

Description:

After exclusion of indications for an emergency operation, conservative treatment is performed up to 12 hours from the moment of admission. Each patient receive blood test, blood lactate investigation, blood biochemistry, X-ray of the abdomen, ultrasound and CT on the admission. Each patient receive water-soluble contrast in 3 h after admission. In case of of clinical and radiologic signs of obstruction in 12 h after admission, surgery is performed. On the first stage of surgical treatment laparoscopic adhesiolysis is performed. If it is impossible to eliminate the cause of obstruction by laparoscopic technique laparotomy is performed.

Treatment:

Radiation: X-ray diagnostics

Procedure: Ultrasound

Radiation: Computer tomography

Other: General and biochemical blood test

Procedure: Adhesiolysis

Late surgery

Active Comparator group

Description:

After exclusion of indications for an emergency operation, conservative treatment is performed up to 48 hours from the moment of admission. Each patient receive blood test, blood lactate investigation, blood biochemistry, X-ray of the abdomen, ultrasound and CT on the admission. Each patient receive water-soluble contrast 3 h after admission. In case of present of obstruction and absence of contrast in colon in 36 h after intake (48 h after admission) a surgery is perform. On the first stage of surgical treatment laparoscopic adhesiolysis is performed. If it is impossible to eliminate the cause of obstruction by laparoscopic technique laparotomy is performed.

Treatment:

Radiation: X-ray diagnostics

Procedure: Ultrasound

Radiation: Computer tomography

Other: General and biochemical blood test

Procedure: Adhesiolysis