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

NCT ID: NCT05682391

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2025-12-31

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.

Conditions

Adenoma Pituitary; CSF Leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Bed rest

Intervention Type: OTHER

Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees

Prospective control - no bed rest after no intraoperative leak

Enters this arm if no intraoperative CSF leakage occurs.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Retrospective control - bed rest after intraoperative leak

Historical control, bed rest applied after intraoperative CSF leakage.

Group Type: ACTIVE_COMPARATOR

Bed rest

Intervention Type: OTHER

Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees

Retrospective control - no bed rest after no intraoperative leak

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bed rest

Strict bed rest ordered after surgery that does not allow the participant to elevate the head of bed over 30 degrees

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

202207083RINA

Identifier Type: -

Identifier Source: org_study_id