Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy

NCT ID: NCT06256263

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-12-31

Brief Summary

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This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.

Detailed Description

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Conditions

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Malignant Tumor of the Larynx

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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stapler repair group

pharyngeal repair after total laryngectomy was done by using a linear stapler

Group Type ACTIVE_COMPARATOR

total laryngectomy

Intervention Type PROCEDURE

pharyngeal repair after total laryngectomy

conventional repair group

pharyngeal repair after total laryngectomy was done by the conventional method (stitching).

Group Type ACTIVE_COMPARATOR

total laryngectomy

Intervention Type PROCEDURE

pharyngeal repair after total laryngectomy

Interventions

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total laryngectomy

pharyngeal repair after total laryngectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration .

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura University faculty of Medicine

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 32723416 (View on PubMed)

Sannikorn 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.

Reference Type BACKGROUND
PMID: 23682529 (View on PubMed)

Shan 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.

Reference Type BACKGROUND
PMID: 29903625 (View on PubMed)

Other Identifiers

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MD.21.06.491

Identifier Type: -

Identifier Source: org_study_id

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