The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study

September 12, 2023 updated by: Nattapat Tangchitcharoen, King Chulalongkorn Memorial Hospital

The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question[s] it aims to answer are:

  • efficacy (patient-reported outcomes, epidural fibrosis)
  • safety (complications) Participants will received Mediclore at surgical site after finish the operation in experimental group and normal saline in control group.

Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized clinical trial arrange in King Chulalongkorn Memorial Hospital. Participant will be randomly assigned into 2 groups by computer-generated sequence. Patients based-line characteristic data, patient-reported outcomes (VAS back/leg, ODI and EQ-5D) and a results of straight leg raising test will be collected. Participant will undergo a endoscopic lumbar discectomy by a singer spine surgeon. In experimental group, 1.5 CC. of Mediclore (poloxamer-based thermosensitive anti-adhesive agent) will be applied in after finish the operation. In control group normal saline 1.5 CC. will be applied instead.

Participants will proceed to regular follow-up protocol which include 1, 3 and 6 months visit at out-patient department. All of the PROs and a result of a straight leg raising test will be collected at each visit. MRI will be performed at 3 month after the surgery. The amount of epidural fibrosis will be evaluated according to Ross's method.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 4

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 Locations

  • Thailand
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330

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:

  • Lumbar disc herniated patients
  • Failed proper conservative treatment more than 6 months

Exclusion Criteria:

  • Previous history of lumbar spine surgery OR lumbar epidural steroid injection
  • Infection OR malignancy
  • Allergic to any given components
  • Lactation and pregnency

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediclore
After finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.
Drug: Mediclore
After finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.
Placebo Comparator: Control
After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.
Drug: Normal Saline
After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score for Leg pain (VAS Leg)
Time Frame: 3 month after surgery
The VAS Leg consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.
3 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score for Leg and Back pain (VAS Leg, Back)
Time Frame: 1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg)
The VAS Leg and Back consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.
1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg)
Oswestry Disability Index (ODI)
Time Frame: 1, 3 and 6 month after surgery
The ODI consists of 10 questions to assess the function in daily activities living, in which the responses are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).
1, 3 and 6 month after surgery
EQ-5D-5L
Time Frame: 1, 3 and 6 month after surgery
The EQ-5D-5L has 2 parts. In the first part, consist of 5 questions to assess the function in daily activities living, in which the responses are presented as 5 level (1 means no problems to 5 means extreme problems). The digits for the five questions can be combined into a 5-digit number that describes the patient's health state. The results will interpreted with the country specific utility score (Thailand) and reported as three decimal digit range from 0 (the worst health you can imagine) to 1 (the best health you can imagine).
1, 3 and 6 month after surgery
Epidural Fibrosis
Time Frame: 3 month after surgery
Evaluation of epidural fibrosis by method proposed by Ross et al (1999) by MRI. From MRI axial cut, A surgical intervertebral level will be marked as level 3, 2 adjacent cephalic image will be marked as level 1 and 2. 2 adjacent caudad level will be marked as level 4 and 5. Then each image will be separated into 4 quadrant. Fibrosis will be graded on a scale of 0-4 for each quadrant at each imaging slice encompassing the operative level: 0 = no/trace scar; 1 = > 0-25% of quadrant filled with scar; 2 = 25-50% of quadrant filled with scar; 3 = 50-75% of quadrant filled with scar; 4 = > 75% of quadrant filled with scar. The highest grade of epidural fibrosis from any image will represent the degree of epidural ficrosis.
3 month after surgery
Complication rate
Time Frame: peri-operation, 1, 3 and 6 month after surgery
peri-operation, 1, 3 and 6 month after surgery
Straight leg raising test
Time Frame: 1, 3 and 6 month after surgery
Straight leg raising test will be performed at each visit. Results will be recorded as negative or positive. If positive, the degree that make a test positive will be also recorded.
1, 3 and 6 month after surgery

Collaborators and Investigators

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

Sponsor

King Chulalongkorn Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

October 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 10, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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