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

NCT05682391 | Enrolling By Invitation

• 1 other identifier: 202207083RINA
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoma Pituitary; CSF Leakage

Keywords

CSF leakage; transsphenoidal adenomectomy; bed rest

Outcome Measures

Primary Outcomes (1)

• Occurrence of CSF leakage within 3 months postoperatively

  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

  12 weeks after the date of surgery

Secondary Outcomes (3)

• Occurrence of meningitis within 3 months postoperatively

  12 weeks after the date of surgery

• Length of hospital stay

  24 weeks after the date of surgery

• Results of 36-Item short form health survey (SF-36) surveys

  On postoperative day 1, postoperative day 7, postoperative day 28, postoperative week 12 and postoperative week 24.

Study Arms (5)

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.

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.

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.

Interventions

Bed rest OTHER

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

Prospective control - bed rest after intraoperative leak; Retrospective control - bed rest after intraoperative leak

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pituitary adenoma requiring surgical resection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pituitary Neoplasms; Cerebrospinal Fluid Rhinorrhea

Interventions

Bed Rest

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Cerebrospinal Fluid Leak; Neurologic Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rhinorrhea; Signs and Symptoms, Respiratory; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 12, 2023
• Study Start: March 2, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)