Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction

Small Bowel Obstruction Clinical Trial

Official title:

Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841069
• Other study ID #: 24121989
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: April 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: Interventional

Clinical Trial Summary

This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).

Description:

Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with acute intestinal obstruction

Exclusion Criteria:

• pregnancy;
• peritonitis or strangulation, revealed during primary examination;
• early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Adhesion
• Small Bowel Obstruction

Intervention

Procedure:
• Adhesiolysis
Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.

Radiation:
• X-ray examination
Plain X-ray of abdomen (1-4 times) with water insoluble contrast.

Procedure:
• Conservative treatment
A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.

Locations

Country	Name	City	State
Russian Federation	26 City Hospital	Saint Petersburg
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	The City Hospital of the Holy Martyr Elizabeth	Saint Petersburg

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	Non-operative treatment success	Frequency of non-operative intestinal obstruction resolution	72 hours
Secondary	Overall mortality	Number of patients, died during hospitalization	up to 30 days
Secondary	Postoperative complications	Number and variety of postoperative complications in patients, who underwent surgery	up to 30 days
Secondary	Resectional interventions	Number of patients, who underwent surgery, including small bowel resection	up to 30 days