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

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-09-01

Brief Summary

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

Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

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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

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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

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

OTHER

Sponsor Role lead

Responsible Party

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Kotkov Pavel

Assistant of the Faculty Surgery Department in NWSMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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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

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Russia

Central Contacts

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Pavel A Kotkov, PhD

Role: CONTACT

+79062619231

Badri V Sigua, MD

Role: CONTACT

+79111979343

Facility Contacts

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Vladislav A Leschenko

Role: primary

+79226336699

Marina P Kuznetsova, PhD

Role: primary

+79097309601

Badri V Sigua, MD

Role: primary

Andrey E Demko, MD

Role: primary

+79215649140

Anna V Glebova, PhD

Role: primary

+79062604541

Pavel A Kotkov

Role: primary

+79062619231

Aleksandr S R, Ryzhih

Role: primary

+79226721179

Kirill V Zubkov

Role: primary

+79923417791

Other Identifiers

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17011993

Identifier Type: -

Identifier Source: org_study_id

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