Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT05682391
NA

Bed Rest on the Effect of CSF Leakage Repair After Transsphenoidal Pituitary Surgery

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

Postoperative cerebrospinal fluid (CSF) leakage is a well-known complication that might occur after transnasal transsphenoidal adenomectomy at an incidence of 0.5-15% according to different literature reports. Persistent CSF leakage may lead to intracranial hypotension or meningitis, therefore aggressive management is mandatory. The treatment is immediate repair during transsphenoidal surgery once intraoperative CSF leakage is identified, with the adjunct of postoperative bed rest and/or lumbar drainage. However, due to the advances in endoscopic endonasal skull base surgery, some surgical teams have advocated that postoperative bed rest may not be necessary if appropriate repair have been performed. High-flow CSF leakage typically occurs in an extended endonasal approach to the anterior or posterior cranial fossa, whereas CSF leakage resulting from transsphenoidal pituitary surgery is usually easier to be repaired. Bed rest is stressful management for patients and poses increased risks in many ways, such as the need for an indwelling urinary catheter, musculoskeletal pain, affected sleep quality, and increased possibility of thromboembolism. It is crucial that the duration of bed rest be cut short or totally avoided if clinically acceptable. In reviewing the literature, there is insufficient evidence supporting the routine use of postoperative bed rest after CSF leakage repair in transsphenoidal surgery. This study aims to compare the efficacy of successful CSF leakage repair with or without postoperative bed rest with an open-label randomized trial design.

Official title: The Impact of Postoperative Bed Rest on the Repair of Cerebrospinal Fluid (CSF) Leakage After Transnasal Transsphenoidal Pituitary Surgery

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2023-03-02

Completion Date

2025-12-31

Last Updated

2024-04-16

Healthy Volunteers

No

Interventions

OTHER

Bed rest

Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees

Locations (1)

Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital

Taipei, Taiwan