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

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

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

Study Overview

• Status: Recruiting
• Conditions: Small Bowel Obstruction; Small Bowel Adhesion; Strangulation of Ileum
• Intervention / Treatment: Procedure: Adhesiolysis; Radiation: X-ray diagnostics; Radiation: Computer tomography; Procedure: Ultrasound; Other: General and biochemical blood test

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander E Tyagunov, MD. Prof; Phone Number: +79165022324; Email: tyagunov1@mail.ru
• Study Contact Backup: Name: Alexander V Sazhin, PhD; Phone Number: +79163904180; Email: Sazhin-AV@yandex.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • Moscow Clinical Hospital 1
    • Contact: Taras Nechay, PhD; Phone Number: +79268146829; Email: tnechay@mail.ru
    • Principal Investigator: Igor Lebedev, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early surgery; 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.	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
Active Comparator: Late surgery; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of patients with obstruction release after conservative treatment	No of patients with success of conservative treatment	in the 2nd group - 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rate in conservative treatment and surgery	12 months readmission rate	12 months
30 days mortality	Number of patients who has dead in 30 days after admission	30 days
Complications rate	Number of complications rate in groups	30 days
Quantity of bowel resection	Number of patients who undergo bowel resection in groups	156 hours

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: conservative treatment; laparoscopic adhesiolysis; strangulation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: 14121729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No