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

Small Bowel Obstruction Clinical Trial

Official title:

Multicenter Non-randomized Controlled Retrospective Study of the Small Bowel Decompression Techniques Comparative Effectiveness in Patients With Benign Small Bowel Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06175442
• Other study ID #: 17011993
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2023
• Source: North-Western State Medical University named after I.I.Mechnikov
• Contact: Pavel A Kotkov, PhD
• Phone: +79062619231
• Email: kotkovdr[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 1, 2024
• Est. primary completion date: May 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk regional clinical hospital	Chelyabinsk
Russian Federation	City Clinical Hospital No. 40	Ekaterinburg
Russian Federation	City Clinical Hospital ?4	Perm
Russian Federation	North-Western State Medical University named after I. I. Mechnikov	Saint Petersburg
Russian Federation	Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine	Saint Petersburg
Russian Federation	St Petersburg State Budgetary Institution Of Health Care City Mariinskaya Hospital	Saint Petersburg
Russian Federation	The City Hospital of the Holy Martyr Elizabeth	Saint Petersburg
Russian Federation	State Healthcare Facility "City Clinical Emergency Hospital No 25"	Volgograd

Sponsors (1)

Lead Sponsor	Collaborator
North-Western State Medical University named after I.I.Mechnikov

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day postoperative mortality	Number of patients, died during 30 days after the operation	30 days after operation
Secondary	Postoperative complications	Postoperative complications, defined according Clavien-Dindo classification	30 days after operation