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

NCT ID: NCT06175442

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will compare results of different intestinal decompression techniques in patients with small bowel obstruction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Small Bowel Obstruction Small Bowel Obstruction Adhesion Small-Bowel Obstruction Due to Volvulus Hernia Incarcerated

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Acute intestinal obstruction, small bowel obstruction, nasointestinal tube, nasogastric tube

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nasogastric tube only (I)

Nasogastric intubation only will be the only method of intestinal decompression both intra- and postoperatively.

Intraoperative intestinal decompression

Intervention Type DEVICE

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.

Intraoperative intestinal decompression

Intervention Type DEVICE

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.

Intraoperative intestinal decompression

Intervention Type DEVICE

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

Intraoperative intestinal decompression

Intervention Type DEVICE

Insertion the tubes of various lengths (nasogastral, short and long nasointestinal) into the gastrointestinal tract during operations in patients with acute small intestinal obstruction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North-Western State Medical University named after I.I.Mechnikov

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kotkov Pavel

Assistant of the Faculty Surgery Department in NWSMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chelyabinsk regional clinical hospital

Chelyabinsk, , Russia

Site Status RECRUITING

City Clinical Hospital №4

Perm, , Russia

Site Status RECRUITING

North-Western State Medical University named after I. I. Mechnikov

Saint Petersburg, , Russia

Site Status RECRUITING

Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine

Saint Petersburg, , Russia

Site Status RECRUITING

St Petersburg State Budgetary Institution Of Health Care City Mariinskaya Hospital

Saint Petersburg, , Russia

Site Status RECRUITING

The City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, , Russia

Site Status RECRUITING

State Healthcare Facility "City Clinical Emergency Hospital No 25"

Volgograd, , Russia

Site Status RECRUITING

City Clinical Hospital No. 40

Yekaterinburg, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pavel A Kotkov, PhD

Role: CONTACT

Phone: +79062619231

Email: [email protected]

Badri V Sigua, MD

Role: CONTACT

Phone: +79111979343

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vladislav A Leschenko

Role: primary

Marina P Kuznetsova, PhD

Role: primary

Badri V Sigua, MD

Role: primary

Andrey E Demko, MD

Role: primary

Anna V Glebova, PhD

Role: primary

Pavel A Kotkov

Role: primary

Aleksandr S R, Ryzhih

Role: primary

Kirill V Zubkov

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17011993

Identifier Type: -

Identifier Source: org_study_id