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CTRI Number  CTRI/2023/11/060063 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of outcomes in stapling & manual suturing for food pipe closure in throat cancer surgery 
Scientific Title of Study   Comparing the outcomes of stapling with manual suturing for pharyngeal closure in laryngectomy  
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinchu S S 
Designation  Junior Resident 
Affiliation  Christian Medical College Vellore 
Address  Department of ENT UNIT 5 Christian medical college Vellore Tamilnadu India
Dr vinchu S S Room no 205 TPK1 opposite cmc hospital katpadi road vellore Tamilnadu 632004
Vellore
TAMIL NADU
632004
India 
Phone  9497007659  
Fax    
Email  vinchu67@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suma Susan Mathews 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Department of ENT UNIT 5 Christian medical college Vellore Tamilnadu India 632004
Department of ENT UNIT 5 Christian medical college Vellore Tamilnadu India 632004
Vellore
TAMIL NADU
632004
India 
Phone  9487901556  
Fax    
Email  sumasusanm@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vinchu S S 
Designation  Junior Resident 
Affiliation  Christian Medical College Vellore 
Address  Department of ENT UNIT 5 Christian medical college Vellore Tamilnadu India
Dr vinchu S S Room no 205 TPK1 opposite cmc hospital katpadi road vellore Tamilnadu 632004
Vellore
TAMIL NADU
632004
India 
Phone  9497007659  
Fax    
Email  vinchu67@gmail.com  
 
Source of Monetary or Material Support  
Institution Internal - Fluid Research Grant (Christian medical college Vellore Tamilnadu) 
 
Primary Sponsor  
Name  Institution Internal - Fluid Research Grant 
Address  Christian Medical College Vellore, Tamil Nadu, India PIN-632004 Phone number-0416-2286089  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr vinchu S S  Christian medical college vellore, Tamil nadu  Department of ENT Unit 5 Christian Medical College Vellore 632004, Tamil Nadu. India Ph. : 0416 2286089 Email id:ent5@cmcvellore.ac.in
Vellore
TAMIL NADU 		 9497007659

vinchu67@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL REVIEW BOARD CHRISTIAN MEDICAL COLLEGE VELLORE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C320||Malignant neoplasm of glottis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator agent- Laryngectomy followed by pharyngeal closure by manual suturing   Comparator agent-Laryngectomy followed by pharyngeal closure by manual suturing  
Intervention  Intervention-Laryngectomy followed by pharyngeal closure using stapler   Intervention-Laryngectomy followed by pharyngeal closure using stapler  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  89.00 Year(s)
Gender  Both 
Details  any subject (irrespective of sex, age> 18 years) with endo laryngeal cancer (primary/salvage laryngectomy) 
 
ExclusionCriteria 
Details  Patients with tumour extending to hypopharynx  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Length of hospital stay
2. Rate of pharyngocutaneous fistula
 		 1. In days
2. Till 3 months post surgery(percentage/number) 
 
Secondary Outcome  
Outcome  TimePoints 
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

 		 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

 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.  
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