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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05682391

Collaborator

(none)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adenoma Pituitary CSF Leakage	Other: Bed rest	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Impact of Postoperative Bed Rest on the Repair of CSF Leakage After Transnasal Transsphenoidal Pituitary Surgery

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.	Other: Bed rest Strict bed rest ordered after surgery that does not allow the patient 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.	Other: Bed rest Strict bed rest ordered after surgery that does not allow the patient 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.

Outcome Measures

Primary Outcome Measures

Occurrence of CSF leakage within 3 months postoperatively [12 weeks after the date of surgery]
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 [12 weeks after the date of surgery]
Any documented meningitis within 3 months postoperatively.
Length of hospital stay [24 weeks after the date of surgery]
The length of stay is calculated from 1 day prior to surgery until the day of discharge.
Results of SF-36 surveys [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 PCS and MCS scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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.