Pharyngocutaneous fistula (PCF) is a serious complication after total laryngectomy. It causes morbidity and prolonged admission in hospital. We want to find out the efficacy of this method to prevent fistula. Forty patients who will be candidate for total laryngectomy attending to Rasool akram and Firuzgar hospital, will be included in this study. We will allocate them in two intervention and control groups through block balanced randomization. In intervention group, after total laryngectomy, neopharynx will be repaired in a T shape. After that, we put a drain on the neopharynx, which takes out from submentum area. We will connect the drain to continuous low negative pressure vacuum (80-120 mmhg) in the third day after surgery until 10 days. If the PCF occurs we will continue suction drainage until discharge less than 25 cc during 24 hours in which suction drainage will be brought out. We do not put drain in 20 patients in the control group. The surgeon will be blind to the allocation. Inclusion criteria: Total laryngectomy. Main outcome: pharyngocutaneous fistula rate. Second outcome: time of recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022532765N1
Registration date:2017-04-09, 1396/01/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-09, 1396/01/20
Registrant information
Name
Zhaleh Faham
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21643524
Email address
drzhfaham@ent-hns.org
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-06-24, 1396/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low-pressure suction drainage on prevention of pharyngocutaneous fistula after total laryngectomy.
Public title
The effect of low-pressure suction drainage on pharyngocutaneous fistula.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Total laryngectomy
Exclusion criteria:-
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat highway. Tehran
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
105/1102/د/IR.IUMS.REC.94
Health conditions studied
1
Description of health condition studied
pharyngocutaneous fistula
ICD-10 code
z92
ICD-10 code description
Personal history of medical treatment
Primary outcomes
1
Description
Pharyngocutaneous fistula
Timepoint
daily from the third day after surgery
Method of measurement
Physical examination
Secondary outcomes
1
Description
time of recovery
Timepoint
after occurance
Method of measurement
amount of fistula discharge with examination
Intervention groups
1
Description
Intervention group: In intervention group, after total laryngectomy, neopharynx will be repaired in a T shape. After that, we put a drain on the neopharynx, which takes out from submentum area. We will connect the drain to continuous low negative pressure vacuum (80-120 mmhg) in the third day after surgery until 10 days. If the PCF occurs we will continue suction drainage until discharge less than 25 cc during 24 hours in which suction drainage will be brought out.
Category
Prevention
2
Description
control: without drain
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool akram hospital
Full name of responsible person
Zhaleh Faham
Street address
Niayesh street, Sattarkhan street
City
Tehran
2
Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Zhaleh Faham
Street address
Valadi street, Behafarin street,Valiasr squre
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Saied javad Musavi
Street address
Iran university of medical science, beside Milad Tower, Hemat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Otorhinolaryngology, Head and Neck surgery group; of Iran University of Medical Sciences
Full name of responsible person
Zhaleh Faham
Position
ENT resident
Other areas of specialty/work
Street address
Rasool akram hospital, Niayesh street, Satarkhan street
City
Tehran
Postal code
Phone
+98 2109181339770
Fax
Email
drzhalehfaham@gmail.com; drzhfaham@ent-hns.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Otorhinolaryngology Head and Neck surgery, Iran University of Medical Sciences