Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03278041 |
| Other study ID # |
454 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
September 7, 2017 |
| Last updated |
September 7, 2017 |
| Start date |
January 30, 2018 |
| Est. completion date |
January 30, 2019 |
Study information
| Verified date |
September 2017 |
| Source |
Cairo University |
| Contact |
omar Q Aladashi, Master |
| Phone |
00201154639509 |
| Email |
omraladashi[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to compare maxillary obturator versus submental artery flap after
partial maxillectomy in the aspect of Quality of life outcomes.
Description:
The maxillary defects created by surgical removal of tumors result in communication between
the oral and nasal cavities that in turn impair speech, swallowing, mastication, and facial
esthetics, all of which consequently affect social behavior and quality of life (QoL).
Consequently, the QoL need to be evaluated in patients with head and neck cancer because
surgical resections and associated problems can affect QoL in significant ways.
University of Washington Head and Neck questionnaire is one of the measuring tools of the
Quality of life, this UW-QOL questionnaire tests 12 domains relating to the patient with head
and neck cancer. The sum score is calculated by adding together the scores for the 12 domains
and dividing by 12 for a score from 0 (for poor health) to 100 (good health).
The maxillary defects reconstruction could be approached with prosthetic obturators
rehabilitation or through surgical correction.
The obturator prostheses have many advantages that include; the easy visualization of the
defect site, which allows for the detection of cancer recurrence; a reduction in the
hospitalization period and costs; the ability to avoid a second operation; and the immediate
re-establishment of facial morphology and oral functioning.However, several disadvantages to
the maxillary obturator exist, including the discomfort of wearing a prosthesis, the
inconvenience of removing and cleaning the prosthesis, the inability to successfully retain a
prosthesis when the defect is large or when dentition is lacking, and the frequent need for
readjustments by a prosthodontist.
The surgical intervention could be with various approaches that provide the reconstruction of
communication and yields good results for the reconstruction of small defects.
The most commonly used surgical technique is the free tissue transfers that associated with
increased hospital time and flap donor area morbidity. Nonetheless, Study conducted by Rogers
et al., compared obturator prosthesis versus free flap surgical repair of the maxillary
defect, the result revealed that there were no statistically significant differences were
found between the two groups regarding quality of life measured with UW-QOL, although there
was a tendency for obturator patients to indicate more problems with appearance. In this
study, the obturator group recorded UW-QOL mean of 74±8.
The drawbacks of previous techniques have led to a search for alternate solutions, the use of
a pedicle submental artery island flap is introduced as a new surgical option for head and
neck tumor reconstruction. The advantages of this approach coming from its donor site can be
performed in very thin section, pliability, and versatility in design. Moreover, the
submental flap can be easily raised and involves shorter operative and hospital time compared
to the free-flap procedure.
The pedicle submental artery island flap can be an excellent choice in patients with a high
American Society of Anesthesiologists (ASA) risk score; moreover, this modality is effective
in elderly patients, where the potential complications linked to microsurgical procedures are
avoided.
There is no published study until now comparing pedicle submental artery island flap with
prosthetic obturators. So that the aim of this study is to answer the following question
"After partial maxillectomy in patients with a palatal defect, Does the submental artery flap
offer different effect on the improvement of the quality of life when compared to maxillary
obturator?"
