Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction
Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction
1 other identifier
interventional
180
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMay 3, 2023
April 1, 2023
12 months
April 11, 2023
April 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non-operative treatment success
Frequency of non-operative intestinal obstruction resolution
72 hours
Secondary Outcomes (3)
Overall mortality
up to 30 days
Postoperative complications
up to 30 days
Resectional interventions
up to 30 days
Study Arms (2)
Short conservative treatment
ACTIVE COMPARATORConservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.
Prolonged conservative treatment
EXPERIMENTALConservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear.
Interventions
Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.
Plain X-ray of abdomen (1-4 times) with water insoluble contrast.
A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.
Eligibility Criteria
You may qualify if:
- patients with acute intestinal obstruction
You may not qualify if:
- pregnancy;
- peritonitis or strangulation, revealed during primary examination;
- early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
26 City Hospital
Saint Petersburg, Russia
North-Western State Medical University named after I. I. Mechnikov
Saint Petersburg, Russia
Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
Saint Petersburg, Russia
The City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, Russia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No masking is expected due to the nature of interventions
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, surgery department assistant
Study Record Dates
First Submitted
April 11, 2023
First Posted
May 3, 2023
Study Start
January 1, 2023
Primary Completion
December 31, 2023
Study Completion
February 1, 2024
Last Updated
May 3, 2023
Record last verified: 2023-04