Management of Seroma After Posterior Lumbar Spine Decompression

NCT07060781 | Recruiting

• 1 other identifier: KFSIRB200-645
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical presentation and management strategies of seroma formation following posterior lumbar spine decompression.

Conditions

Seroma; Lumbar Spine Decompression

Outcome Measures

Primary Outcomes (1)

• Incidence of seroma

  Incidence of seroma formation following posterior lumbar spine decompression will be recorded during hospitalization and at scheduled postoperative follow-up visits at 2 weeks, 6 weeks, 3 months, and 6 months.

  6 months postoperatively

Secondary Outcomes (3)

• Number of aspirations required

  6 months postoperatively

• Seroma recurrence rate

  6 months postoperatively

• Association with patient risk factor

  6 months postoperatively

Study Arms (1)

Study group

Patients undergoing elective posterior lumbar spine decompression.

Procedure: Posterior Lumbar Spine Decompression

Interventions

Posterior Lumbar Spine Decompression PROCEDURE

Patients undergoing elective posterior lumbar spine decompression.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study will be conducted on 50 adult patients undergoing posterior lumbar spine decompression surgery at Kafr Elsheikh University Hospitals. Approval from the Medical Sciences Ethics Committee of Kafr Elsheikh Faculty of Medicine will be taken. Written informed consent will be obtained from all participants before enrollment.

You may qualify if:

• Age ≥ 18 years.
• Both sexes.
• Patients undergoing elective posterior lumbar spine decompression.

You may not qualify if:

• History of previous lumbar spine surgery.
• Active spinal infection, trauma, or malignancy.
• Severe medical comorbidities that contraindicate surgery or influence wound healing (e.g., uncontrolled diabetes, immunosuppression, severe cardiovascular disease).
• Patients unfit for general anesthesia.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ayman M Basha, MD

CONTACT

00201063037278; aymanbasha424@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 19, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)