Small Bowel ObstructionNCT06175442
Effectiveness of Small Bowel Decompression Techniques in Patients With Small Bowel Obstruction
An observational study of Small Bowel Obstruction and Small Bowel Obstruction Adhesion, run by North-Western State Medical University named after I.I.Mechnikov at 8 sites in Russia.
Trial summary
This study will compare results of different intestinal decompression techniques in patients with small bowel 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 Obstruction Adhesion, Small-Bowel Obstruction Due to Volvulus
- What is being tested?
- Intraoperative intestinal decompression
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 8 sitesRussia
- Study dates
- 1 Dec 2023to 1 Sep 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Adult patients with benign forms of acute small intestinal obstruction and indications for the small intestine intubation: dilation of the the small intestine lumen above the level of a mechanical obstacle to 3.0 cm in diameter or more or the presence of intestinal paresis with the development of edema and microcirculatory disorders in intestinal wall.
Who may be able to join
- acute adhesive intestinal obstruction, including strangulation forms;
- incarcerated ventral hernias, accompanied by impaired intestinal passage;
- acute adhesive intestinal obstruction in the hernial sac;
- obstruction of the small intestine lumen with gallstones and other foreign bodies.
Who cannot join
- with peritonitis and other complicated surgical infection;
- operations with intestinal resection;
- patients after laparostomy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites, 8 recruiting
- Recruiting
Chelyabinsk regional clinical hospital
Chelyabinsk
Vladislav A Leschenko, +79226336699
- Recruiting
City Clinical Hospital №4
Perm
Marina P Kuznetsova, PhD, +79097309601, gensurperm@mail.ru
- Recruiting
North-Western State Medical University named after I. I. Mechnikov
Saint Petersburg
Badri V Sigua, MD
- Recruiting
Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
Saint Petersburg
Andrey E Demko, MD, +79215649140, ingo@lspbgmu.ru
- Recruiting
St Petersburg State Budgetary Institution Of Health Care City Mariinskaya Hospital
Saint Petersburg
Anna V Glebova, PhD, +79062604541, glebova.anna@mail.ru
- Recruiting
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg
Pavel A Kotkov, +79062619231
- Recruiting
State Healthcare Facility "City Clinical Emergency Hospital No 25"
Volgograd
Aleksandr S R, Ryzhih, +79226721179
- Recruiting
City Clinical Hospital No. 40
Yekaterinburg
Kirill V Zubkov, +79923417791, kirill_zubkov_98@mail.ru
About this study
Official title: Multicenter Non-randomized Controlled Retrospective Study of the Small Bowel Decompression Techniques Comparative Effectiveness in Patients With Benign Small Bowel Obstruction
This study will compare results of different intestinal decompression techniques in patients with small bowel obstruction.
Read the detailed description
Taking into account the large number of different variations of intestinal decompression methods, a comparative analysis will be carried out based on one comparison group (I) and three main ones (IA-B). The comparison criterion will be a group of patients with nasogastric drainage as the only method of the gastrointestinal tract decompression during surgery and in the postoperative period. In the main groups more active methods of intestinal decompression will be performed, including drainage of the initial parts of the small intestine or total intubation, both single-stage intraoperative and its extended version
- Conditions
- Small Bowel Obstruction, Small Bowel Obstruction Adhesion, Small-Bowel Obstruction Due to Volvulus, Hernia Incarcerated
- Being tested
- Intraoperative intestinal decompression
- Keywords
- Acute intestinal obstruction, small bowel obstruction, nasointestinal tube, nasogastric tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative intestinal decompressionDevice
Insertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric tube only (I) | Nasogastric intubation only will be the only method of intestinal decompression both intra- and postoperatively. Receives: Device: Intraoperative intestinal decompression | |
| Short nasointestinal tube (IIA) | Intraoperative intestinal decompression will be performed by placing the tube behind the ligament of Treitz and expressing the contents in the proximal direction or by total nasointestinal intubation with subsequent intraopertional tube withdrawal. Postoperative decompression will consist of the tube behind the ligament of Treitz. Receives: Device: Intraoperative intestinal decompression | |
| Long nasointestinal tube intraoperative (IIB) | Total intraoperative intubation of the small intestine followed by replacement with a nasogastric tube. Receives: Device: Intraoperative intestinal decompression | |
| Long nasointestinal tube postoperative (IIC) | Total intraoperative intubation of the small intestine with a long tube, which will persist in the postoperative period Receives: Device: Intraoperative intestinal decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative mortality
Number of patients, died during 30 days after the operation
Measured: 30 days after operation
Secondary outcomes (1)
Postoperative complications
Postoperative complications, defined according Clavien-Dindo classification
Measured: 30 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Dec 2023
- Primary completion31 May 2024 (estimated)
- Study completion1 Sep 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 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
- NCT06175442
- Sponsor's protocol ID
- 17011993
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Non-randomized Controlled Retrospective Study of the Small Bowel Decompression Techniques Comparative Effectiveness in Patients With Benign Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT06175442
- Acronym / sponsor ID
- 17011993
- Conditions
- Small Bowel Obstruction, Small Bowel Obstruction Adhesion, Small-Bowel Obstruction Due to Volvulus, Hernia Incarcerated
- Keywords
- Acute intestinal obstruction, small bowel obstruction, nasointestinal tube, nasogastric tube
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- North-Western State Medical University named after I.I.MechnikovUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 Dec 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 results of different intestinal decompression techniques in patients with small bowel obstruction.
Detailed description
Taking into account the large number of different variations of intestinal decompression methods, a comparative analysis will be carried out based on one comparison group (I) and three main ones (IA-B). The comparison criterion will be a group of patients with nasogastric drainage as the only method of the gastrointestinal tract decompression during surgery and in the postoperative period. In the main groups more active methods of intestinal decompression will be performed, including drainage of the initial parts of the small intestine or total intubation, both single-stage intraoperative and its extended version
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nasogastric tube only (I) | – | Device: Intraoperative intestinal decompressionNasogastric intubation only will be the only method of intestinal decompression both intra- and postoperatively. |
| Short nasointestinal tube (IIA) | – | Device: Intraoperative intestinal decompressionIntraoperative intestinal decompression will be performed by placing the tube behind the ligament of Treitz and expressing the contents in the proximal direction or by total nasointestinal intubation with subsequent intraopertional tube withdrawal. Postoperative decompression will consist of the tube behind the ligament of Treitz. |
| Long nasointestinal tube intraoperative (IIB) | – | Device: Intraoperative intestinal decompressionTotal intraoperative intubation of the small intestine followed by replacement with a nasogastric tube. |
| Long nasointestinal tube postoperative (IIC) | – | Device: Intraoperative intestinal decompressionTotal intraoperative intubation of the small intestine with a long tube, which will persist in the postoperative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with benign forms of acute small intestinal obstruction and indications for the small intestine intubation: dilation of the the small intestine lumen above the level of a mechanical obstacle to 3.0 cm in diameter or more or the presence of intestinal paresis with the development of edema and microcirculatory disorders in intestinal wall.
Key inclusion criteria (4 listed)
- acute adhesive intestinal obstruction, including strangulation forms;
- incarcerated ventral hernias, accompanied by impaired intestinal passage;
- acute adhesive intestinal obstruction in the hernial sac;
- obstruction of the small intestine lumen with gallstones and other foreign bodies.
Key exclusion criteria (3 listed)
- with peritonitis and other complicated surgical infection;
- operations with intestinal resection;
- patients after laparostomy
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 |
|---|---|---|
| Intraoperative intestinal decompressionInsertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction | Device | Long nasointestinal tube intraoperative (IIB), Long nasointestinal tube postoperative (IIC), Nasogastric tube only (I), Short nasointestinal tube (IIA) |
Primary outcome
30-day postoperative mortality
Time frame: 30 days after operation
Number of patients, died during 30 days after the operation
1 secondary outcome
Postoperative complications
Time frame: 30 days after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Obstruction and Small Bowel Obstruction Adhesion, run by North-Western State Medical University named after I.I.Mechnikov at 8 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 4 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
30-day postoperative mortality (time frame: 30 days after operation). 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 18 Dec 2023.