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Does removal of cerebrospinal fluid from lowerback in surgery for the pituitary tumor decrease the cerebrospinal fluid leak through the nose

Role of intraoperative lumbar cerebrospinal fluid drainage in patients undergoing transsphenoidal surgery for pituitary adenoma - NA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005021
Enrollment
60
Registered
2014-09-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pituitary adenoma

Interventions

Intervention1: Intervention: The intervention group will have the drain inserted at the time of surgery and the comparator group will not have the lumbar drain inserted at the time of surgery Control

Sponsors

CMC Vellore IRB
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients newly diagnosed to have a pituitary adenoma and undergoing endoscopic transsphenoidal surgery

Exclusion criteria

Exclusion criteria: Patients in whom an expanded endoscopic transsphenoidal surgery is planed will be excluded since we intentionally open the arachnoid over the planum sphenoidale in these cases Previous transsphenoidal surgery , Previous radiation therapy , patients with spinal deformities and patients with deranged bleeding parameters

Design outcomes

Primary

MeasureTime frame
To determine the incidence of intraoperative and postoperative CSF leakTimepoint: Intraoperative leak will determined by the surgeon at the time of surgery. The postoperative leak will be determined by the ENT surgeon on the seventh postoperative day through a nasal scopy

Secondary

MeasureTime frame
To determine the extent of tumor excision by the radiologist in the immediate postoperative period using a hyperacute MRITimepoint: In the immediate postoperative period up to the first postoperative day

Countries

India

Contacts

Public ContactDr G Edmond Jonathan

Christian Medical college

gandham.edmond@gmail.com9003803609

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026