Short and Prolonged Conservative Treatment in Patients With Adhesive Intestinal Obstruction

April 21, 2023 updated by: Kotkov Pavel, North-Western State Medical University named after I.I.Mechnikov

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation
        • Recruiting
        • 26 City Hospital
        • Contact:
          • Mikhail A Protchenkov, PhD
      • Saint Petersburg, Russian Federation
        • Recruiting
        • North-Western State Medical University named after I. I. Mechnikov
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • The City Hospital of the Holy Martyr Elizabeth
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Short conservative treatment
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.
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.
Experimental: Prolonged conservative treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-operative treatment success
Time Frame: 72 hours
Frequency of non-operative intestinal obstruction resolution
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall mortality
Time Frame: up to 30 days
Number of patients, died during hospitalization
up to 30 days
Postoperative complications
Time Frame: up to 30 days
Number and variety of postoperative complications in patients, who underwent surgery
up to 30 days
Resectional interventions
Time Frame: up to 30 days
Number of patients, who underwent surgery, including small bowel resection
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North-Western State Medical University named after I.I.Mechnikov

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24121989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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