- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05682391
Bed Rest on the Effect of CSF Leakage Repair After Transsphenoidal Pituitary Surgery
The Impact of Postoperative Bed Rest on the Repair of Cerebrospinal Fluid (CSF) Leakage After Transnasal Transsphenoidal Pituitary Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huan-Chih Wang, MD
- Phone Number: +886972655831
- Email: jessehcwang@ntu.edu.tw
Study Locations
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-
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Taipei, Taiwan
- Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Prospective experimental - no bed rest after intraoperative leak
Randomized after surgery if intraoperative CSF leakage occurs.
The ratio for allocating into arm 1 vs. arm 2 is 2:1.
|
|
Active Comparator: Prospective control - bed rest after intraoperative leak
Randomized after surgery if intraoperative CSF leakage occurs.
The ratio for allocating into arm 1 vs. arm 2 is 2:1.
|
Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees
|
No Intervention: Prospective control - no bed rest after no intraoperative leak
Enters this arm if no intraoperative CSF leakage occurs.
|
|
Active Comparator: Retrospective control - bed rest after intraoperative leak
Historical control, bed rest applied after intraoperative CSF leakage.
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Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees
|
No Intervention: Retrospective control - no bed rest after no intraoperative leak
Historical control, bed rest not applied after no intraoperative CSF leakage.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of CSF leakage within 3 months postoperatively
Time Frame: 12 weeks after the date of surgery
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Any documented CSF leakage within 3 months postoperatively. Confirmation of CSF leakage could either be:
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12 weeks after the date of surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of meningitis within 3 months postoperatively
Time Frame: 12 weeks after the date of surgery
|
Any documented meningitis within 3 months postoperatively.
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12 weeks after the date of surgery
|
Length of hospital stay
Time Frame: 24 weeks after the date of surgery
|
The length of stay is calculated from 1 day prior to surgery until the day of discharge.
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24 weeks after the date of surgery
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Results of 36-Item short form health survey (SF-36) surveys
Time Frame: On postoperative day 1, postoperative day 7, postoperative day 28, postoperative week 12 and postoperative week 24.
|
SF-36 with its 8 subscales as well as the physical component summary (PCS) and mental component summary (MCS) scores.
Each of the 8 subscales (physical functioning [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], and mental health [MH]) has a minimum value of 0 and maximum value of 100, a higher score relates to a better outcome.
The PCS score is the average score of PF, RP, BP, and GH, while the MCS score is the average score of VT, SF, RE, and MH (both has the minimum value of 0 and maximum value of 100, a higher score relates to a better outcome).
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On postoperative day 1, postoperative day 7, postoperative day 28, postoperative week 12 and postoperative week 24.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neurologic Manifestations
- Wounds and Injuries
- Endocrine System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Hypothalamic Diseases
- Adenoma
- Pituitary Diseases
- Cerebrospinal Fluid Leak
Other Study ID Numbers
- 202207083RINA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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