Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy
Linear Stapler Versus Conventional Repair of the Pharynx After Total Laryngectomy: Functional and Oncological Outcomes
1 other identifier
interventional
58
1 country
1
Brief Summary
This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFirst Submitted
Initial submission to the registry
February 3, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedFebruary 13, 2024
February 1, 2024
2.6 years
February 3, 2024
February 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of pharyngocutaneous fistula after total laryngectomy
to assess the effectiveness of pharyngeal repair and healing without pharyngocutaneous fistula
four weeks
Secondary Outcomes (1)
assessment of the swallowing function after surgery
6 months
Study Arms (2)
stapler repair group
ACTIVE COMPARATORpharyngeal repair after total laryngectomy was done by using a linear stapler
conventional repair group
ACTIVE COMPARATORpharyngeal repair after total laryngectomy was done by the conventional method (stitching).
Interventions
pharyngeal repair after total laryngectomy
Eligibility Criteria
You may qualify if:
- All consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration .
You may not qualify if:
- Infiltration of the safety margins proved by postoperative histopathology .
- Patients with tumor extension to the tongue base, or the hypopharynx .
- Patients who are unfit for surgery .
- Patients refusal to surgical treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University faculty of Medicine
Al Mansurah, 35511, Egypt
Related Publications (3)
Sansa-Perna A, Casasayas-Plass M, Rovira-Martinez C, Lopez-Vilas M, Garcia-Lorenzo J, Quer-Agusti M, Leon-Vintro X. Pharyngeal closure after a total laryngectomy: mechanical versus manual technique. J Laryngol Otol. 2020 Jul;134(7):626-631. doi: 10.1017/S0022215120001371. Epub 2020 Jul 29.
PMID: 32723416BACKGROUNDSannikorn P, Pornniwes N. Comparison of outcomes for staple and conventional closure of the pharynx following total laryngectomy. J Med Assoc Thai. 2013 Mar;96 Suppl 3:S89-93.
PMID: 23682529BACKGROUNDShan H, Gao Y, Liu L, Li M, Gao X, Li Y, Wang X, Ouyang D, Guo Z. Magnifying endoscopy with narrow-band imaging to assist the linear stapler closure of the pharynx during total laryngectomy. Am J Otolaryngol. 2018 Sep-Oct;39(5):511-514. doi: 10.1016/j.amjoto.2018.05.014. Epub 2018 May 28.
PMID: 29903625BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2024
First Posted
February 13, 2024
Study Start
June 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 13, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share