A randomized controlled trial to evaluate the effectiveness of ‘Early postoperative ambulation’ on clinical outcomes and quality of life in patients undergoing endonasal surgery for pituitary region tumors admitted in Neurosurgical units, PGIMER, Chandigarh, 2024-26.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- quality of life
Study Overview
Brief Summary
This randomized controlled trial aims to evaluate the effectiveness of early postoperative ambulation on clinical outcomes and quality of life in patients undergoing endonasal surgery for pituitary region tumors at PGIMER, Chandigarh. A total of 80 adult patients will be selected and randomly allocated using a computer-generated random number table with allocation concealment, assigning 40 participants each to the experimental (early ambulation + routine care) and control (routine care only) groups. Inclusion criteria include adult patients undergoing endonasal surgery who are ambulatory and able to begin walking within 12 hours post-lumbar puncture. Outcome variables include postoperative complications, duration of hospital stay, headache severity, sinus-related quality of life (SNOT-22), and WHOQOL scores. Data will be collected through interviews, clinical records, and standardized tools. Follow-ups will be done on postoperative days 1 to 3 and at discharge, with a final assessment at one month post-surgery. Data will be analyzed using descriptive and inferential statistics. The findings will help support early ambulation practices to enhance recovery and improve the quality of life in neurosurgical patients.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult patients planned for endo nasal surgery for pituitary region tumor who are ambulatory without support before surgery.
- •Patients willing to participate in study.
- •Patients who undergo a lumbar puncture postoperatively will have early ambulation started after 12 hours of lumbar puncture.
Exclusion Criteria
- •Patients who are unconscious.
- •Patients who are intubated beyond 11am on post operative day
- •Patients who are hemodynamically unstable, whose systolic blood pressure is less than 100 mm Hg. 4.Patients who have lumbar drain during surgery.
Outcomes
Primary Outcomes
quality of life
Time Frame: at the end of 1 month after surgery
Secondary Outcomes
- clinical outcomes- 1. Headache(2. Post operative complications- CSF rhinorrhea, DVT and others)