Adenoma PituitaryNCT05682391
Bed Rest on the Effect of CSF Leakage Repair After Transsphenoidal Pituitary Surgery
A study testing Bed rest in people with Adenoma Pituitary and CSF Leakage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adenoma Pituitary, CSF Leakage
- What is being tested?
- Bed rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pituitary adenoma requiring surgical resection.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital
Taipei
About this study
Official title: 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.
Read the 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.
- Conditions
- Adenoma Pituitary, CSF Leakage
- Being tested
- Bed rest
- Keywords
- CSF leakage, transsphenoidal adenomectomy, bed rest
- Medical subject headings
- Pituitary Neoplasms, Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed restOther
Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees
| Study group | Role | What they receive |
|---|---|---|
| Prospective experimental - no bed rest after intraoperative leak | No intervention | Randomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1. |
| Prospective control - bed rest after intraoperative leak | Active comparator | Randomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1. Receives: Other: Bed rest |
| Prospective control - no bed rest after no intraoperative leak | No intervention | Enters this arm if no intraoperative CSF leakage occurs. |
| Retrospective control - bed rest after intraoperative leak | Active comparator | Historical control, bed rest applied after intraoperative CSF leakage. Receives: Other: Bed rest |
| Retrospective control - no bed rest after no intraoperative leak | No intervention | Historical control, bed rest not applied after no intraoperative CSF leakage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of CSF leakage within 3 months postoperatively
Any documented CSF leakage within 3 months postoperatively. Confirmation of CSF leakage could either be:
- typical symptoms of CSF rhinorrhea, plus visible clear and colorless rhinorrhea with positive glucose response
- atypical symptoms of CSF rhinorrhea, plus visualization of clear and colorless fluid from the operative site via sinoscope
- atypical symptoms of CSF rhinorrhea, plus identifiable fluid accumulation in the sphenoid sinus and suspicious site of CSF fistula via neuroimaging modalities
Measured: 12 weeks after the date of surgery
Secondary outcomes (3)
Occurrence of meningitis within 3 months postoperatively
Any documented meningitis within 3 months postoperatively.
Measured: 12 weeks after the date of surgery
Length of hospital stay
The length of stay is calculated from 1 day prior to surgery until the day of discharge.
Measured: 24 weeks after the date of surgery
Results of 36-Item short form health survey (SF-36) surveys
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).
Measured: On postoperative day 1, postoperative day 7, postoperative day 28, postoperative week 12 and postoperative week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start2 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoma PituitaryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682391
- Sponsor's protocol ID
- 202207083RINA
- Status last verified
- Apr 2024
- First submitted
- 27 Dec 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Postoperative Bed Rest on the Repair of Cerebrospinal Fluid (CSF) Leakage After Transnasal Transsphenoidal Pituitary Surgery
- ClinicalTrials.gov ID
- NCT05682391
- Acronym / sponsor ID
- 202207083RINA
- Conditions
- Adenoma Pituitary, CSF Leakage
- Keywords
- CSF leakage, transsphenoidal adenomectomy, bed rest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Prospective experimental - no bed rest after intraoperative leak | No intervention | –Randomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1. |
| Prospective control - bed rest after intraoperative leak | Active comparator | Other: Bed restRandomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1. |
| Prospective control - no bed rest after no intraoperative leak | No intervention | –Enters this arm if no intraoperative CSF leakage occurs. |
| Retrospective control - bed rest after intraoperative leak | Active comparator | Other: Bed restHistorical control, bed rest applied after intraoperative CSF leakage. |
| Retrospective control - no bed rest after no intraoperative leak | No intervention | –Historical control, bed rest not applied after no intraoperative CSF leakage. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with pituitary adenoma requiring surgical resection.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bed restStrict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees | Other | Prospective control - bed rest after intraoperative leak, Retrospective control - bed rest after intraoperative leak |
Primary outcome
Occurrence of CSF leakage within 3 months postoperatively
Time frame: 12 weeks after the date of surgery
Any documented CSF leakage within 3 months postoperatively. Confirmation of CSF leakage could either be: 1. typical symptoms of CSF rhinorrhea, plus visible clear and colorless rhinorrhea with positive glucose response 2. atypical symptoms of CSF rhinorrhea, plus visualization of clear and colorless fluid from the operative site via sinoscope 3. atypical symptoms of CSF rhinorrhea, plus identifiable fluid accumulation in the sphenoid sinus and suspicious site of CSF fistula via neuroimaging modalities
3 secondary outcomes
Occurrence of meningitis within 3 months postoperatively
Time frame: 12 weeks after the date of surgery
Length of hospital stay
Time frame: 24 weeks after the date of surgery
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed rest in people with Adenoma Pituitary and CSF Leakage, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of CSF leakage within 3 months postoperatively (time frame: 12 weeks after the date of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.