Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study

August 12, 2025 updated by: Reham Zakaria Mohamed Ahmed, Zagazig University
Adhesive Intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. Most of them (73% - 90%) can be managed conservatively.Despite advances in surgery, 15to 30% require surgical intervention primarily or due to failure of conservative management. Because of the nature of the disease recurrence has been estimated to be 30%.Many attempts to prevent formation of postoperative adhesions have been tried. In this trial, we will study the effect of corticosteroids and FFP in prevention of adhesive small bowel obstruction recurrence for follow up of 2 years duration.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

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 Locations

  • Egypt
      • Zagazig, Egypt, 44519
        • Zagazig university hospitals
    • Sharqia
      • Zagazig, Sharqia, Egypt, 44519
        • Faculty of medicine

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 attacks of adhesive intestinal obstruction

Exclusion Criteria:

  • Associated abdominal malignancy, patients with adhesive IO who respond to conservative treatment.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group I: adhesive intestinal obstruction
Procedure: intra-abdominal instillation of corticosteroids
after adhesiolysis, peritoneal lavage with diluted corticosteroids will be instillated intra-abdominally
Active Comparator: group II: adhesive intestinal obstruction
Procedure: intra-abdominal instillation of fresh frozen plasma
after adhesiolysis, peritoneal lavage with diluted FFP will be instillated intra-abdominally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intestinal obstruction
Time Frame: from 1 day to 2 years post operative
intestinal obstruction is detected if the patient had constipation and vomiting with ultrasound showing dilated bowel and to and fro movement and the plain erect shows multiple air fluid levels
from 1 day to 2 years post operative
bowel injury
Time Frame: from 1 day to 2 years post operative
bowel injury will be detected if intestinal contents present in the drain or wound
from 1 day to 2 years post operative
wound infection
Time Frame: from 1 day to 2 weeks post-operative
wound infection is detected if there is pus in the drain or wound
from 1 day to 2 weeks post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
age
Time Frame: from 2 to 3 days before surgery
age will be recorded in years
from 2 to 3 days before surgery
sex
Time Frame: from 2 to 3 days before surgery
The sex of the patient will be recorded (male or female)
from 2 to 3 days before surgery

Collaborators and Investigators

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

Sponsor

Zagazig University

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)

March 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #1109\25-Feb-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

data will be available on demand by contacting the principle investigator

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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