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

Primary Purpose

Small Bowel Obstruction, Small Bowel Adhesion, Strangulation of Ileum

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Adhesiolysis
X-ray diagnostics
Computer tomography
Ultrasound
General and biochemical blood test
Sponsored by
Pirogov Russian National Research Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Bowel Obstruction focused on measuring conservative treatment, laparoscopic adhesiolysis, strangulation

Eligibility Criteria

17 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Moscow Clinical Hospital 1Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early surgery

Late surgery

Arm 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.

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.

Outcomes

Primary Outcome Measures

Quantity of patients with obstruction release after conservative treatment
No of patients with success of conservative treatment

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2017
Last Updated
March 29, 2023
Sponsor
Pirogov Russian National Research Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03139149
Brief Title
Comparison of Early Operative Treatment and 48 h Conservative Treatment in Small Bowel Obstruction
Acronym
COTACSO
Official Title
Comparison of Early Operative Treatment (12 h) and 48 h Conservative Treatment in Acute Small Bowel Obstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pirogov Russian National Research Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction, Small Bowel Adhesion, Strangulation of Ileum
Keywords
conservative treatment, laparoscopic adhesiolysis, strangulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early surgery
Arm Type
Active Comparator
Arm 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.
Arm Title
Late surgery
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Adhesiolysis
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
X-ray diagnostics
Intervention Description
X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.
Intervention Type
Radiation
Intervention Name(s)
Computer tomography
Intervention Description
Computer tomography of abdomen with iv contrast
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound of the abdomen (2 times)
Intervention Type
Other
Intervention Name(s)
General and biochemical blood test
Intervention Description
General blood test and biochemical blood test 2 times a day
Primary Outcome Measure Information:
Title
Quantity of patients with obstruction release after conservative treatment
Description
No of patients with success of conservative treatment
Time Frame
in the 2nd group - 48 hours
Secondary Outcome Measure Information:
Title
Readmission rate in conservative treatment and surgery
Description
12 months readmission rate
Time Frame
12 months
Title
30 days mortality
Description
Number of patients who has dead in 30 days after admission
Time Frame
30 days
Title
Complications rate
Description
Number of complications rate in groups
Time Frame
30 days
Title
Quantity of bowel resection
Description
Number of patients who undergo bowel resection in groups
Time Frame
156 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander E Tyagunov, MD. Prof
Phone
+79165022324
Email
tyagunov1@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander V Sazhin, PhD
Phone
+79163904180
Email
Sazhin-AV@yandex.ru
Facility Information:
Facility Name
Moscow Clinical Hospital 1
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taras Nechay, PhD
Phone
+79268146829
Email
tnechay@mail.ru
First Name & Middle Initial & Last Name & Degree
Igor Lebedev, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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