Comparison of outcomes in stapling & manual suturing for food pipe closure in throat cancer surgery

Comparing the outcomes of stapling with manual suturing for pharyngeal closure in laryngectomy - NA

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060063

Enrollment

Registered

2023-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: C320- Malignant neoplasm of glottis

Interventions

Intervention1: Intervention-Laryngectomy followed by pharyngeal closure using stapler : Intervention-Laryngectomy followed by pharyngeal closure using stapler Control Intervention1: Comparator agent-

Eligibility

Inclusion criteria

Inclusion criteria: any subject (irrespective of sex, age > 18 years) with endo laryngeal cancer (primary/salvage laryngectomy)

Exclusion criteria

Exclusion criteria: Patients with tumour extending to hypopharynx

Design outcomes

Primary

Measure	Time frame
1. Length of hospital stay 2. Rate of pharyngocutaneous fistula Timepoint: 1. In days 2. Till 3 months post surgery(percentage/number)	—

Secondary

Measure	Time frame
1.Pharyngeal closure time 2.Total surgery duration 3.Oncological margins 4.Blood loss 5.Assessment of swallowing after surgery 6.The time required before safely feed orally 7. Cost analysis – under separate variables a.theatre time in mins, b.hospital stay in days, c.stapler/ suture cost in INR 8.Post-operative infection and other complications Timepoint: 1.Calculated in operation theatre 2.Calculated in operation theatre 3.Histopathological examination report 4.calculated in operation theatre after surgery 5.before initiation of RT or 1-month post-surgery- whichever is earlier 6.Not applicable 7.Not applicable 8.Till 3 months post surgery	—

Measure

Time frame

1.Pharyngeal closure time 2.Total surgery duration 3.Oncological margins 4.Blood loss 5.Assessment of swallowing after surgery 6.The time required before safely feed orally 7. Cost analysis – under separate variables a.theatre time in mins, b.hospital stay in days, c.stapler/ suture cost in INR 8.Post-operative infection and other complications Timepoint: 1.Calculated in operation theatre 2.Calculated in operation theatre 3.Histopathological examination report 4.calculated in operation theatre after surgery 5.before initiation of RT or 1-month post-surgery- whichever is earlier 6.Not applicable 7.Not applicable 8.Till 3 months post surgery

—

Countries

India

Contacts

Public ContactDr Vinchu S S

Christian Medical College Vellore

sumasusanm@yahoo.co.in9487901556

Outcome results

None listed

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