Mobilisation Algorithm After Incidental Durotomy

NCT02927782 | Unknown DMC

• 1 other identifier: W569
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with persistent symptoms of cerebrospinal-fluid leakage (positional headache, photophobia, nausea and vomiting, clear drainage from the wound, fluctuant subcutaneous wound) after a primary repair should be considered for revision surgery to avoid potentially serious complications including CSF (cerebro spinal fluid) fistula formation. Prolonged bed rest immediatel after reapir of an ID () incidental durotomy) is widely accepted and frequently applied. current literature provides supporting retrospective evidence that prolonged bed rest may not be required after watertight closure of dural tears. The purpose of this study is to further investigate the impact of prolonged bed rest on the need for early reoperation following primary repair of an ID after lumbar spinal surgery. The primary endpoint of this study is the difference in reoperation rate between the two study groups to further investigate if either one or the other postoperative mobilisation regimen provides a significant benefit in terms of persistent dural leakage.

Conditions

Cerebrospinal Fluid Leak

Keywords

Cerebrospinal Fluid Leak; Lumbar

Outcome Measures

Primary Outcomes (1)

• Reoperation rate

  The primary endpoint of this study is the difference in reoperation rate between the two study groups to further investigate if either one or the other postoperative mobilisation regimen provides a significant benefit in terms of persistent dural leakage.

  6 weeks

Study Arms (2)

Bed Rest

ACTIVE COMPARATOR

48 hours of strict bed rest after incidental durotomy during lumbar spinal surgery

Procedure: Bed Rest

Early Mobilization

EXPERIMENTAL

Immediate Mobilization after incidental durotomy during lumbar spinal surgery

Procedure: Early Mobilization

Interventions

Early Mobilization PROCEDURE

early postoperative mobilisation (walking and sitting). Initial postoperative mobilisation is going to be under supervision of a qualified physiotherapist. The presence of a qualified physiotherapist at first mobilisation is solely for reasons of safety. No specific exercise or regimen is planned.

Early Mobilization

Bed Rest PROCEDURE

48 hours of strict bed rest followed by postoperative mobilisation under supervision of a qualified physiotherapist. During the bed rest period elevation of the head is tolerated to a maximum of 30°.

Bed Rest

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients over the age of 18 years with an ID sustained during a primary or revision lumbar spinal procedure at our institution are the subject of this prospective, randomised analysis.

You may not qualify if:

• Patients referred for repair of an externally sustained ID, cases in which durotomy was not primarily recognised and repaired as well as patient who refuse to sign informed consent are going to be excluded from this analysis. Informed consent is going to be obtained one day prior to index procedure.
• Further Intervention because of Spondylitis/Spondylodiscitis, Tumor, Trauma. Pregnant patients

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

University Hospital Balgrist

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Cerebrospinal Fluid Leak

Interventions

Early Ambulation; Bed Rest

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Mazda Farshad, MD MPH

  University Hospital Balgrist Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mazda Farshad, MD MPH

CONTACT

+413861274; mazda.farshad@balgrist.ch

David Bauer, MD

CONTACT

+413865759; david.bauer@balgrist.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MPH

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 7, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)