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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

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)

December 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 16, 2023

First Posted (Estimated)

December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 16, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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