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Not Yet Recruiting NCT05682391

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

Conditions: Adenoma Pituitary, CSF Leakage

Sex: All
Ages: 20 Years – N/A
Phase: NA
Enrollment: 180
Sponsor: National Taiwan University Hospital

Summary

Postoperative 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 we cut short or even discard the management of bed rest 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. Our study aims to compare the efficacy of successful CSF leakage repair with or without postoperative bed rest with an open-label randomized trial design.

Eligibility Criteria

Inclusion Criteria:Patients with pituitary adenoma requiring surgical resection.Exclusion Criteria:Spontaneous CSF leakage occurs prior to transsphenoidal surgery.The growth of adenoma extends to anterior cranial fossa or clival region.The growth of adenoma extends to 3rd ventricle.Prior history of transsphenoidal surgery.Prior history of radiotherapy or radiosurgery to the sella or nearby skull base region.Class 2 obesity or extremely obese: BMI ≧35.Pregnant or lactating women.Patients who could not give informed consent.

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Source: ClinicalTrials.gov (NCT05682391). StuddyBuddy aggregates publicly available trial information.