Comparison of outcomes in stapling & manual suturing for food pipe closure in throat cancer surgery
Phase 3
- Conditions
- Health Condition 1: C320- Malignant neoplasm of glottis
- Registration Number
- CTRI/2023/11/060063
- Lead Sponsor
- Institution Internal - Fluid Research Grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
any subject (irrespective of sex, age > 18 years) with endo laryngeal cancer (primary/salvage laryngectomy)
Exclusion Criteria
Patients with tumour extending to hypopharynx
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Length of hospital stay <br/ ><br>2. Rate of pharyngocutaneous fistula <br/ ><br>Timepoint: 1. In days <br/ ><br>2. Till 3 months post surgery(percentage/number)
- Secondary Outcome Measures
Name Time Method 1.Pharyngeal closure time <br/ ><br>2.Total surgery duration <br/ ><br>3.Oncological margins <br/ ><br>4.Blood loss <br/ ><br>5.Assessment of swallowing after surgery <br/ ><br>6.The time required before safely feed orally <br/ ><br>7. Cost analysis – under separate variables <br/ ><br>a.theatre time in mins, <br/ ><br>b.hospital stay in days, <br/ ><br>c.stapler/ suture cost in INR <br/ ><br>8.Post-operative infection and other complications <br/ ><br> <br/ ><br>Timepoint: 1.Calculated in operation theatre <br/ ><br>2.Calculated in operation theatre <br/ ><br>3.Histopathological examination report <br/ ><br>4.calculated in operation theatre after surgery <br/ ><br>5.before initiation of RT or 1-month post-surgery- whichever is earlier <br/ ><br>6.Not applicable <br/ ><br>7.Not applicable <br/ ><br>8.Till 3 months post surgery <br/ ><br> <br/ ><br>