Small Bowel ObstructionCOTACSONCT03139149
Comparison of Early Operative Treatment and 48 h Conservative Treatment in Small Bowel Obstruction
A study testing Adhesiolysis, X-ray diagnostics and Computer tomography in people with Small Bowel Obstruction and Small Bowel Adhesion, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Small Bowel Obstruction, Small Bowel Adhesion, Strangulation of Ileum
- What is being tested?
- Adhesiolysis, X-ray diagnostics and Computer tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 11 Oct 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with adhesive small bowel obstruction
Who cannot join
- Early postoperative small bowel obstruction Irreducible hernia Strangulation or peritonitis symptoms Impairment of consciousness Unstable hemodynamics
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Moscow Clinical Hospital 1
Moscow
Taras Nechay, PhD, +79268146829, tnechay@mail.ru
Igor Lebedev, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Adhesiolysis, X-ray diagnostics, Computer tomography, Ultrasound, General and biochemical blood test
- Keywords
- conservative treatment, laparoscopic adhesiolysis, strangulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdhesiolysisProcedure or surgery
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.
X-ray diagnosticsRadiation
X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.
Computer tomographyRadiation
Computer tomography of abdomen with iv contrast
UltrasoundProcedure or surgery
Ultrasound of the abdomen (2 times)
General and biochemical blood testOther
General blood test and biochemical blood test 2 times a day
| Study group | Role | What they receive |
|---|---|---|
| Early surgery | Active comparator | 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. Receives: Procedure: Adhesiolysis; Radiation: X-ray diagnostics; Radiation: Computer tomography; Procedure: Ultrasound; Other: General and biochemical blood test |
| Late surgery | Active comparator | 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. Receives: Procedure: Adhesiolysis; Radiation: X-ray diagnostics; Radiation: Computer tomography; Procedure: Ultrasound; Other: General and biochemical blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of patients with obstruction release after conservative treatment
No of patients with success of conservative treatment
Measured: in the 2nd group - 48 hours
Secondary outcomes (4)
Readmission rate in conservative treatment and surgery
12 months readmission rate
Measured: 12 months
30 days mortality
Number of patients who has dead in 30 days after admission
Measured: 30 days
Complications rate
Number of complications rate in groups
Measured: 30 days
Quantity of bowel resection
Number of patients who undergo bowel resection in groups
Measured: 156 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start11 Oct 2017
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander E. Tyagunov, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139149
- Sponsor's protocol ID
- 14121729
- Acronym
- COTACSO
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2017
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Operative Treatment (12 h) and 48 h Conservative Treatment in Acute Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT03139149
- Acronym / sponsor ID
- COTACSO / 14121729
- Keywords
- conservative treatment, laparoscopic adhesiolysis, strangulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surgery | Active comparator | Procedure: Adhesiolysis, Radiation: X-ray diagnostics, Radiation: Computer tomography, Procedure: Ultrasound, Other: General and biochemical blood testAfter 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. |
| Late surgery | Active comparator | Procedure: Adhesiolysis, Radiation: X-ray diagnostics, Radiation: Computer tomography, Procedure: Ultrasound, Other: General and biochemical blood testAfter 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. |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with adhesive small bowel obstruction
Key exclusion criteria (1 listed)
- Early postoperative small bowel obstruction Irreducible hernia Strangulation or peritonitis symptoms Impairment of consciousness Unstable hemodynamics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdhesiolysisMethod 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. | Procedure or surgery | Early surgery, Late surgery |
| X-ray diagnosticsX-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast. | Radiation | Early surgery, Late surgery |
| Computer tomographyComputer tomography of abdomen with iv contrast | Radiation | Early surgery, Late surgery |
| UltrasoundUltrasound of the abdomen (2 times) | Procedure or surgery | Early surgery, Late surgery |
| General and biochemical blood testGeneral blood test and biochemical blood test 2 times a day | Other | Early surgery, Late surgery |
Primary outcome
Quantity of patients with obstruction release after conservative treatment
Time frame: in the 2nd group - 48 hours
No of patients with success of conservative treatment
4 secondary outcomes
Readmission rate in conservative treatment and surgery
Time frame: 12 months
30 days mortality
Time frame: 30 days
Complications rate
Time frame: 30 days
Quantity of bowel resection
Time frame: 156 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesiolysis, X-ray diagnostics and Computer tomography in people with Small Bowel Obstruction and Small Bowel Adhesion, run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander E Tyagunov, MD. Prof (+79165022324, tyagunov1@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity of patients with obstruction release after conservative treatment (time frame: in the 2nd group - 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.