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

Primary Purpose

Adenoma Pituitary, CSF Leakage

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bed rest
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoma Pituitary focused on measuring CSF leakage, transsphenoidal adenomectomy, bed rest

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Active Comparator

No Intervention

Active Comparator

No Intervention

Arm Label

Prospective experimental - no bed rest after intraoperative leak

Prospective control - bed rest after intraoperative leak

Prospective control - no bed rest after no intraoperative leak

Retrospective control - bed rest after intraoperative leak

Retrospective control - no bed rest after no intraoperative leak

Arm Description

Randomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1.

Randomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1.

Enters this arm if no intraoperative CSF leakage occurs.

Historical control, bed rest applied after intraoperative CSF leakage.

Historical control, bed rest not applied after no intraoperative CSF leakage.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Occurrence of meningitis within 3 months postoperatively
Any documented meningitis within 3 months postoperatively.
Length of hospital stay
The length of stay is calculated from 1 day prior to surgery until the day of discharge.
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).

Full Information

First Posted
December 27, 2022
Last Updated
March 6, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05682391
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Pituitary, CSF Leakage
Keywords
CSF leakage, transsphenoidal adenomectomy, bed rest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective experimental - no bed rest after intraoperative leak
Arm Type
No Intervention
Arm Description
Randomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1.
Arm Title
Prospective control - bed rest after intraoperative leak
Arm Type
Active Comparator
Arm Description
Randomized after surgery if intraoperative CSF leakage occurs. The ratio for allocating into arm 1 vs. arm 2 is 2:1.
Arm Title
Prospective control - no bed rest after no intraoperative leak
Arm Type
No Intervention
Arm Description
Enters this arm if no intraoperative CSF leakage occurs.
Arm Title
Retrospective control - bed rest after intraoperative leak
Arm Type
Active Comparator
Arm Description
Historical control, bed rest applied after intraoperative CSF leakage.
Arm Title
Retrospective control - no bed rest after no intraoperative leak
Arm Type
No Intervention
Arm Description
Historical control, bed rest not applied after no intraoperative CSF leakage.
Intervention Type
Other
Intervention Name(s)
Bed rest
Intervention Description
Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees
Primary Outcome Measure Information:
Title
Occurrence of CSF leakage within 3 months postoperatively
Description
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
Time Frame
12 weeks after the date of surgery
Secondary Outcome Measure Information:
Title
Occurrence of meningitis within 3 months postoperatively
Description
Any documented meningitis within 3 months postoperatively.
Time Frame
12 weeks after the date of surgery
Title
Length of hospital stay
Description
The length of stay is calculated from 1 day prior to surgery until the day of discharge.
Time Frame
24 weeks after the date of surgery
Title
Results of 36-Item short form health survey (SF-36) surveys
Description
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).
Time Frame
On postoperative day 1, postoperative day 7, postoperative day 28, postoperative week 12 and postoperative week 24.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Division of Neurosurgery, Department of Surgery, National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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