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

NCT ID: NCT06859307

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-03-01

Brief Summary

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.

Conditions

Adhesive Peritoneal Band

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group I: adhesive intestinal obstruction

Group Type: ACTIVE_COMPARATOR

intra-abdominal instillation of corticosteroids

Intervention Type: PROCEDURE

after adhesiolysis, peritoneal lavage with diluted corticosteroids will be instillated intra-abdominally

group II: adhesive intestinal obstruction

Group Type: ACTIVE_COMPARATOR

intra-abdominal instillation of fresh frozen plasma

Intervention Type: PROCEDURE

after adhesiolysis, peritoneal lavage with diluted FFP will be instillated intra-abdominally

Interventions

intra-abdominal instillation of corticosteroids

after adhesiolysis, peritoneal lavage with diluted corticosteroids will be instillated intra-abdominally

Intervention Type: PROCEDURE

intra-abdominal instillation of fresh frozen plasma

after adhesiolysis, peritoneal lavage with diluted FFP will be instillated intra-abdominally

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with attacks of adhesive intestinal obstruction

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Reham Zakaria Mohamed Ahmed

lecturer of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Zagazig, Sharqia Province, Egypt

Zagazig University Hospitals

Zagazig, zagazig, Egypt

Countries

Egypt

Other Identifiers

#1109\25-Feb-2025

Identifier Type: -

Identifier Source: org_study_id