Back to resultsShort and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction
Primary Purpose
Small Bowel Obstruction, Small Bowel Adhesion
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Adhesiolysis
X-ray examination
Conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Small Bowel Obstruction focused on measuring Acute adhesive intestinal obstruction, conservative treatment
Eligibility Criteria
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)
Sites / Locations
- 26 City HospitalRecruiting
- North-Western State Medical University named after I. I. MechnikovRecruiting
- Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency MedicineRecruiting
- The City Hospital of the Holy Martyr ElizabethRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Short conservative treatment
Prolonged conservative treatment
Arm Description
Conservative 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.
Conservative 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.
Outcomes
Primary Outcome Measures
Non-operative treatment success
Frequency of non-operative intestinal obstruction resolution
Secondary Outcome Measures
Overall mortality
Number of patients, died during hospitalization
Postoperative complications
Number and variety of postoperative complications in patients, who underwent surgery
Resectional interventions
Number of patients, who underwent surgery, including small bowel resection
Full Information
NCT ID
NCT05841069
First Posted
April 11, 2023
Last Updated
April 21, 2023
Sponsor
North-Western State Medical University named after I.I.Mechnikov
1. Study Identification
Unique Protocol Identification Number
NCT05841069
Brief Title
Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction
Official Title
Multicenter Controlled Randomized Prospective Study of the Comparative Efficacy of Early and Delayed Surgical Interventions in Patients With Acute Adhesive Intestinal Obstruction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North-Western State Medical University named after I.I.Mechnikov
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction, Small Bowel Adhesion
Keywords
Acute adhesive intestinal obstruction, conservative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicenter controlled randomized prospective study
Masking
None (Open Label)
Masking Description
No masking is expected due to the nature of interventions
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short conservative treatment
Arm Type
Active Comparator
Arm Description
Conservative 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.
Arm Title
Prolonged conservative treatment
Arm Type
Experimental
Arm Description
Conservative 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.
Intervention Type
Procedure
Intervention Name(s)
Adhesiolysis
Intervention Description
Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.
Intervention Type
Radiation
Intervention Name(s)
X-ray examination
Intervention Description
Plain X-ray of abdomen (1-4 times) with water insoluble contrast.
Intervention Type
Procedure
Intervention Name(s)
Conservative treatment
Intervention Description
A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.
Primary Outcome Measure Information:
Title
Non-operative treatment success
Description
Frequency of non-operative intestinal obstruction resolution
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Overall mortality
Description
Number of patients, died during hospitalization
Time Frame
up to 30 days
Title
Postoperative complications
Description
Number and variety of postoperative complications in patients, who underwent surgery
Time Frame
up to 30 days
Title
Resectional interventions
Description
Number of patients, who underwent surgery, including small bowel resection
Time Frame
up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel A Kotkov, PhD
Phone
+79062619231
Email
kotkovdr@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Badri V Sigua, MD
Phone
+79111979343
Email
dr.sigua@gmail.com
Facility Information:
Facility Name
26 City Hospital
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikhail A Protchenkov, PhD
Facility Name
North-Western State Medical University named after I. I. Mechnikov
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Badri V Sigua, MD
Phone
+79111979343
Email
dr.sigua@gmail.com
Facility Name
Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksei V Osipov, MD
Phone
+79219338603
Email
osipov@emergency.spb.ru
Facility Name
The City Hospital of the Holy Martyr Elizabeth
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel A Kotkov, PhD
Phone
+79062619231
Email
kotkovdr@mail.ru
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction
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