Clinical trial NCT05682391: Bed Rest on the Effect of CSF Leakage Repair After Transsphenoidal Pituitary Surgery
Official title: The Impact of Postoperative Bed Rest on the Repair of Cerebrospinal Fluid (CSF) Leakage After Transnasal Transsphenoidal Pituitary Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Adenoma Pituitary
CSF Leakage
Keywords: CSF leakage
transsphenoidal adenomectomy
bed rest
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 reason that a postoperative CSF leakage would occur mostly is due to the rupture of arachnoid membrane caused by intraoperative manipulation, resulting in direct communication between the subarachnoid space and the nasal cavity. Even when in cases without intraoperative CSF leakage detected, there is a reported incidence of 1.3% of postoperative CSF leakage.

The rate of intraoperative CSF leakage varies in different tumor sizes, tumor extents, tumor natures, and surgical teams, and it could not be precisely documented as 23.3-60% were reported. 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.

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.

Primary outcomes:
measure: Occurrence of CSF leakage within 3 months postoperatively
timeFrame: 12 weeks after the date of surgery
Secondary outcomes:
measure: Occurrence of meningitis within 3 months postoperatively
timeFrame: 12 weeks after the date of surgery
measure: Length of hospital stay
timeFrame: 24 weeks after the date of surgery
measure: Results of 36-Item short form health survey (SF-36) surveys
timeFrame: On postoperative day 1, postoperative day 7, postoperative day 28, postoperative week 12 and postoperative week 24.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital
Study officials:
References: