Clinical trial NCT06175442: Effectiveness of Small Bowel Decompression Techniques in Patients With Small Bowel Obstruction
Official title: Multicenter Non-randomized Controlled Retrospective Study of the Small Bowel Decompression Techniques Comparative Effectiveness in Patients With Benign Small Bowel Obstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: North-Western State Medical University named after I.I.Mechnikov
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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

Eligibility criteria: 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

Primary outcomes:
measure: 30-day postoperative mortality
timeFrame: 30 days after operation
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 days after operation
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk regional clinical hospital
city: Ekaterinburg
country: Russian Federation
facility: City Clinical Hospital No. 40
city: Perm
country: Russian Federation
facility: City Clinical Hospital №4
city: Saint Petersburg
country: Russian Federation
facility: North-Western State Medical University named after I. I. Mechnikov
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
city: Saint Petersburg
country: Russian Federation
facility: St Petersburg State Budgetary Institution Of Health Care City Mariinskaya Hospital
city: Saint Petersburg
country: Russian Federation
facility: The City Hospital of the Holy Martyr Elizabeth
city: Volgograd
country: Russian Federation
facility: State Healthcare Facility "City Clinical Emergency Hospital No 25"
Study officials:
References: