Small Bowel ObstructionNCT05841069
Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction
A study testing Adhesiolysis, X-ray examination and Conservative treatment in people with Small Bowel Obstruction and Small Bowel Adhesion, run by North-Western State Medical University named after I.I.Mechnikov at 4 sites in Russia.
Trial summary
This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction, Small Bowel Adhesion
- What is being tested?
- Adhesiolysis, X-ray examination and Conservative treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 4 sitesRussia
- Study dates
- 1 Jan 2023to 1 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with acute intestinal obstruction
Who cannot join
- pregnancy;
- peritonitis or strangulation, revealed during primary examination;
- early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
Trial locations and contacts
4 sites in 1 country.
Russia4 sites, 4 recruiting
- Recruiting
26 City Hospital
Saint Petersburg
Mikhail A Protchenkov, PhD
- Recruiting
North-Western State Medical University named after I. I. Mechnikov
Saint Petersburg
Badri V Sigua, MD, +79111979343, dr.sigua@gmail.com
- Recruiting
Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
Saint Petersburg
Aleksei V Osipov, MD, +79219338603, osipov@emergency.spb.ru
- Recruiting
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg
Pavel A Kotkov, PhD, +79062619231, kotkovdr@mail.ru
About this study
Official title: Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction
This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).
Read the detailed description
Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.
- Conditions
- Small Bowel Obstruction, Small Bowel Adhesion
- Being tested
- Adhesiolysis, X-ray examination, Conservative treatment
- Keywords
- Acute adhesive intestinal obstruction, conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdhesiolysisProcedure or surgery
Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.
X-ray examinationRadiation
Plain X-ray of abdomen (1-4 times) with water insoluble contrast.
Conservative treatmentProcedure or surgery
A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.
| Study group | Role | What they receive |
|---|---|---|
| Short conservative treatment | Active comparator | Conservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear. Receives: Procedure: Adhesiolysis; Radiation: X-ray examination; Procedure: Conservative treatment |
| Prolonged conservative treatment | Experimental | Conservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear. Receives: Procedure: Adhesiolysis; Radiation: X-ray examination; Procedure: Conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-operative treatment success
Frequency of non-operative intestinal obstruction resolution
Measured: 72 hours
Secondary outcomes (3)
Overall mortality
Number of patients, died during hospitalization
Measured: up to 30 days
Postoperative complications
Number and variety of postoperative complications in patients, who underwent surgery
Measured: up to 30 days
Resectional interventions
Number of patients, who underwent surgery, including small bowel resection
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Feb 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
- Model description
- Multicenter controlled randomized prospective study
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North-Western State Medical University named after I.I.Mechnikov
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kotkov Pavel, North-Western State Medical University named after I.I.Mechnikov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841069
- Sponsor's protocol ID
- 24121989
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction
- ClinicalTrials.gov ID
- NCT05841069
- Acronym / sponsor ID
- 24121989
- Conditions
- Small Bowel Obstruction, Small Bowel Adhesion
- Keywords
- Acute adhesive intestinal obstruction, conservative treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- North-Western State Medical University named after I.I.MechnikovUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 3 May 2023 (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 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).
Detailed description
Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter controlled randomized prospective study
| Arm | Type | Receives |
|---|---|---|
| Short conservative treatment | Active comparator | Procedure: Adhesiolysis, Radiation: X-ray examination, Procedure: Conservative treatmentConservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear. |
| Prolonged conservative treatment | Experimental | Procedure: Adhesiolysis, Radiation: X-ray examination, Procedure: Conservative treatmentConservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with acute intestinal obstruction
Key exclusion criteria (3 listed)
- pregnancy;
- peritonitis or strangulation, revealed during primary examination;
- early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
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 |
|---|---|---|
| AdhesiolysisMedian laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis. | Procedure or surgery | Prolonged conservative treatment, Short conservative treatment |
| X-ray examinationPlain X-ray of abdomen (1-4 times) with water insoluble contrast. | Radiation | Prolonged conservative treatment, Short conservative treatment |
| Conservative treatmentA set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy. | Procedure or surgery | Prolonged conservative treatment, Short conservative treatment |
Primary outcome
Non-operative treatment success
Time frame: 72 hours
Frequency of non-operative intestinal obstruction resolution
3 secondary outcomes
Overall mortality
Time frame: up to 30 days
Postoperative complications
Time frame: up to 30 days
Resectional interventions
Time frame: up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Small Bowel Obstruction
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Management of Non Emergency Adhesive Small Bowel Obstruction:
SBO - Small Bowel Obstruction
RecruitingObservational study
Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD)
Recruiting
The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial
Small Bowel Obstruction, Intestinal Obstruction and Ileus
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.
4 sites 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 examination and Conservative treatment in people with Small Bowel Obstruction and Small Bowel Adhesion, run by North-Western State Medical University named after I.I.Mechnikov at 4 sites 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 3 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Pavel A Kotkov, PhD (+79062619231, kotkovdr@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-operative treatment success (time frame: 72 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 3 May 2023.