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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03139149
Acronym
COTACSO
Enrollment
200
Registered
2017-05-03
Start date
2017-10-11
Completion date
2024-12-31
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Bowel Obstruction, Small Bowel Adhesion, Strangulation of Ileum

Keywords

conservative treatment, laparoscopic adhesiolysis, strangulation

Brief 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.

Interventions

PROCEDUREAdhesiolysis

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.

RADIATIONX-ray diagnostics

X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.

Computer tomography of abdomen with iv contrast

PROCEDUREUltrasound

Ultrasound of the abdomen (2 times)

OTHERGeneral and biochemical blood test

General blood test and biochemical blood test 2 times a day

Sponsors

Pirogov Russian National Research Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantity of patients with obstruction release after conservative treatmentin the 2nd group - 48 hoursNo of patients with success of conservative treatment

Secondary

MeasureTime frameDescription
Readmission rate in conservative treatment and surgery12 months12 months readmission rate
30 days mortality30 daysNumber of patients who has dead in 30 days after admission
Complications rate30 daysNumber of complications rate in groups
Quantity of bowel resection156 hoursNumber of patients who undergo bowel resection in groups

Countries

Russia

Contacts

Primary ContactAlexander E Tyagunov, MD. Prof
tyagunov1@mail.ru+79165022324
Backup ContactAlexander V Sazhin, PhD
Sazhin-AV@yandex.ru+79163904180

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026