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

NCT06175442 | Unknown

• 1 other identifier: 17011993
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• 30-day postoperative mortality

  Number of patients, died during 30 days after the operation

  30 days after operation

Secondary Outcomes (1)

• Postoperative complications

  30 days after operation

Study Arms (4)

Nasogastric tube only (I)

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

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.

Device: Intraoperative intestinal decompression

Long nasointestinal tube intraoperative (IIB)

Total intraoperative intubation of the small intestine followed by replacement with a nasogastric tube.

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

Device: Intraoperative intestinal decompression

Interventions

Intraoperative intestinal decompression 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); Long nasointestinal tube postoperative (IIC); Nasogastric tube only (I); Short nasointestinal tube (IIA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• North-Western State Medical University named after I.I.Mechnikov: lead

Study Sites (8)

Chelyabinsk regional clinical hospital

Chelyabinsk, Russia

RECRUITING

City Clinical Hospital №4

Perm, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

St Petersburg State Budgetary Institution Of Health Care City Mariinskaya Hospital

Saint Petersburg, Russia

RECRUITING

The City Hospital of the Holy Martyr Elizabeth

Saint Petersburg, Russia

RECRUITING

State Healthcare Facility "City Clinical Emergency Hospital No 25"

Volgograd, Russia

RECRUITING

City Clinical Hospital No. 40

Yekaterinburg, Russia

RECRUITING

Central Study Contacts

Pavel A Kotkov, PhD

CONTACT

+79062619231; kotkovdr@mail.ru

Badri V Sigua, MD

CONTACT

+79111979343; dr.sigua@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant of the Faculty Surgery Department in NWSMU

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 18, 2023
• Study Start: December 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: September 1, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (8)