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Status unknownNCT03364166Updated Dec 6, 2017

Recurrence in Buccinator Muscle Excision With the Skin Versus Without the Skin in Buccal Squamous Cell Carcinoma

An interventional study of surgical excision in Squamous Cell Carcinoma of the Oral Cavity, sponsored by Cairo University. Status unknown. Per ClinicalTrials.gov, last updated 2017-12-06.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Sex
All
01

Study summary

Evaluation of local control in buccinator muscle excision with the skin versus buccinator muscle excision without the skin in buccal squamous cell carcinoma: A randomized clinical trial.

Read the detailed description

Preoperative Multi Slice CT scan or MRI carried out for evaluation the lymph node of the neck. Also, ultrasound carried out for measuring the depth of invasion of the tumour in the cheek (The invasion in the buccinator muscle).

  • Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.
  • A neck dissection will be done in all cases of negative or positive neck lymph node.
  • Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.
02

Conditions studied

  • Squamous Cell Carcinoma of the Oral Cavity

Keywords

  • buccal squamous cell carcinoma
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients suffering from buccal squamous cell carcinoma.
  • Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
  • Both sexes and all ages will be included in the study.
  • Cooperative patients, who accept the procedure and return for follow up , examination and evaluation.

Exclusion criteria

Exclusion Criteria:

  • Patients with any systemic disease that may affect normal healing.9,10
  • Patients who physically and psychologically not able to tolerate the procedures.
  • Patients may discontinue the follow up.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    buccinator muscle excision with skin

    surgical excision of the buccinator muscle with the skin in buccal squamous cell carcinoma and neck dissection also done

    Procedure: surgical excision

  • Active comparator
    buccinator muscle excision without skin

    surgical excision the buccinator muscle without the skin in buccal squamous cell carcinoma and neck dissection also done.

    Procedure: surgical excision

Interventions

  • Proceduresurgical excision

    * Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour. * A neck dissection will be done in all cases of negative or positive neck lymph node. * Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery.

05

What researchers measure

Primary outcomes

  1. local control

    (recurrence rate)

    Time frame: up to 1 year

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03364166
Lead sponsor
Cairo University
Responsible party
Ahmed Yuseef (principle investigator, Cairo University) — Principal investigator
First posted
Dec 6, 2017
Start date
Dec 2017 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
Dec 6, 2017

Study contacts

ahmed yousef, PHD
Contact
dr.ayousef@ymail.com
01067941236
ragia mounir, professor
study director · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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