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Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy

M

Mansoura University

Status

Completed

Conditions

Malignant Tumor of the Larynx

Treatments

Procedure: total laryngectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06256263
MD.21.06.491

Details and patient eligibility

About

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

Enrollment

58 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

58 participants in 2 patient groups

stapler repair group
Active Comparator group
Description:
pharyngeal repair after total laryngectomy was done by using a linear stapler
Treatment:
Procedure: total laryngectomy
conventional repair group
Active Comparator group
Description:
pharyngeal repair after total laryngectomy was done by the conventional method (stitching).
Treatment:
Procedure: total laryngectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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