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Clinical Trials/CTRI/2023/11/060063
CTRI/2023/11/060063RecruitingPhase 3

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

Institution Internal - Fluid Research Grant1 site in 1 country60 target enrollmentStarted: January 12, 2023Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
1. Length of hospital stay

Study Overview

Brief Summary

Laryngeal malignancies comprise upto 20% of head and neck cancers in india. sixty to eighty percentage of these are glottic malignancies.Total laryngectomy first performed by Theodor Billroth in 1873,is still the mainstay surgical treatment for advanced stage of laryngeal cancer, amenable to complete resection.It also forms an important salvage surgery option for patient who have failed organ preserving options like chemoradiation, radiotherapy alone or endolaryngeal laser surgery.Since the larynx shares common wall with posteriorly placed pharynx; post laryngectomy, the remaining larynx need to be closed anteriorly to make it a complete tube again. Pharyngocutaneous fistula is the one of the most common complication following  total laryngectomy, with reported rate varying between 3 to 65%.Various patient factors, disease factors and technique related factors found to have influence the formation of pharyngocutaneous fistula.The most commonly occured day 3 to day 8 post surgery and its presence is associated with higher morbidity, longer hospital stay, increased costs.The presence of a pharyngocutaneous fistula significantly delays the initiation of post operative radiotherapy, which leads to worse outcomes.Amongst the modifiable surgical technique related factors, a meticulous closure technique to close the pharyngeal defect after having adequately clear margin is paramount in preventing pharyngocutaneous fistula.There are two main methods for neopharynx closure,While conventional manual suturing of the mucosal and the muscle layers is the one commonly done,the other, more recently introduced-linear stapler pharyngoplsty is a novel technique which was first used post laryngectomy in 1971.Over the last few decades , it has gained popularity.Various studies have shown to reduce surgery time to approximately 80 minutes and lowers the fistula rate (22.9% vs 8.7%).The main aim of the presented study was to prospectively evaluate  and compare the outcomes of patients undergoing pharyngeal closure with the linear stapler or conventional suture technique after total laryngectomy.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 89.00 Year(s) (—)
Sex
All

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.

Outcomes

Primary Outcomes

1. Length of hospital stay

Time Frame: 1. In days | 2. Till 3 months post surgery(percentage/number)

2. Rate of pharyngocutaneous fistula

Time Frame: 1. In days | 2. Till 3 months post surgery(percentage/number)

Secondary Outcomes

  • 1.Pharyngeal closure time(2.Total surgery duration)

Investigators

Sponsor
Institution Internal - Fluid Research Grant
Sponsor Class
Private medical college

Study Sites (1)

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