Effectiveness of Small Bowel Decompression Techniques in Patients With Small Bowel Obstruction

December 16, 2023 updated by: Kotkov Pavel, North-Western State Medical University named after I.I.Mechnikov

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Recruiting
        • Chelyabinsk Regional Clinical Hospital
        • Contact:
          • Vladislav A Leschenko
          • Phone Number: +79226336699
      • Ekaterinburg, Russian Federation
        • Recruiting
        • City Clinical Hospital No. 40
        • Contact:
      • Perm, Russian Federation
        • Recruiting
        • City Clinical Hospital №4
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • North-Western State Medical University named after I. I. Mechnikov
        • Contact:
          • Badri V Sigua, MD
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Saint-Petersburg I.I. Dzhanelidze research institute of emergency medicine
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • The City Hospital of the Holy Martyr Elizabeth
        • Contact:
          • Pavel A Kotkov
          • Phone Number: +79062619231
      • Saint Petersburg, Russian Federation
        • Recruiting
        • St Petersburg State Budgetary Institution Of Health Care City Mariinskaya Hospital
        • Contact:
      • Volgograd, Russian Federation
        • Recruiting
        • State Healthcare Facility "City Clinical Emergency Hospital No 25"
        • Contact:
          • Aleksandr S R, Ryzhih
          • Phone Number: +79226721179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • with peritonitis and other complicated surgical infection;
  • operations with intestinal resection;
  • patients after laparostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Nasogastric tube only (I)
Nasogastric intubation only will be the only method of intestinal decompression both intra- and postoperatively.
Device: Intraoperative intestinal decompression
Insertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction
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.
Device: Intraoperative intestinal decompression
Insertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction
Long nasointestinal tube intraoperative (IIB)
Total intraoperative intubation of the small intestine followed by replacement with a nasogastric tube.
Device: Intraoperative intestinal decompression
Insertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction
Long nasointestinal tube postoperative (IIC)
Total intraoperative intubation of the small intestine with a long tube, which will persist in the postoperative period
Device: Intraoperative intestinal decompression
Insertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
30-day postoperative mortality
Time Frame: 30 days after operation
Number of patients, died during 30 days after the operation
30 days after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days after operation
Postoperative complications, defined according Clavien-Dindo classification
30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
North-Western State Medical University named after I.I.Mechnikov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17011993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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