Study Goal: Pulmonary complications are the most common complications after esophageal resection. In this study we examined the effect of steroids administration during surgery to reduce postoperative morbidity with a focus on respiratory complications.
include and exclude criteria: Patients who had appropriate indication for transhiatal esophagectomy were elected and dose who need neoadjuvant therapy or three hole esophagectomy excluded from study.
studied population: Patients with esophageal cancer who underwent transhiatal esophagectomy, divided into two groups: The intervention group (received 125mg methylprednisolone sodium succinate) and a control group.
number of cases: 60 patients
studied interventions:Postoperative complications included anastomotic fistula, wound infection in the neck and abdomen and pulmonary complications. We analyzed pulmonary complications included pneumonia, ALI or ARDS occurred before the seventh day. The leukocyte count and CRP levels measured on the 2nd and 7th days after surgery.
initial results: Preoperative single dose corticosteroids are effective in preventing pulmonary complications after transhiatal esophagectomy. Methylprednisolone reduced the increase in CRP levels after surgery and decreased blood leukocyte count more in postoperative period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710092517N3
Registration date:2017-10-28, 1396/08/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-28, 1396/08/06
Registrant information
Name
Reza Bagheri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 921 346 3752
Email address
bagherir@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
none
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of intraoperative, single-bolus corticosteroid dose to prevent postoperative respiratory complication after transhiatal esophagectomy
Public title
Efficacy of intraoperative, corticosteroidto prevent postoperative respiratory complicationl esophagectomy
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: esophageal cancer; indication for transhiatal esophagectomy; not using corticosteroids; tending to participate in the study
exclusion criteria: change in surgery program; use of cortons before surgery; need neoadjuvant therapy; three hole esophagectomy
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
mashhad univercity of medical sciences
Street address
daneshgah st.
City
Mashhad
Postal code
098
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
IR.mums.REC.1393.137
Health conditions studied
1
Description of health condition studied
esophageal cancer
ICD-10 code
C15.9
ICD-10 code description
Malignant neoplasm of oesophagus
Primary outcomes
1
Description
respiratory complications
Timepoint
2nd and 7th days after surgery
Method of measurement
blood factors (cc)
Secondary outcomes
empty
Intervention groups
1
Description
the control group did not receivied the corton
Category
Treatment - Drugs
2
Description
The intervention group received 125mg methylprednisolone sodium succinate
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Hosp.
Full name of responsible person
Reza Bagheri
Street address
Ahmadabad street, Qaem hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Reza Bagheri
Street address
Qaem Hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
mashshad university of medical sciences
Full name of responsible person
dr. Reza Bagheri
Position
MD
Other areas of specialty/work
Street address
Qaem hospital
City
Mashhad
Postal code
098
Phone
+98 921 346 3752
Fax
Email
bagherir@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
mashahd university of medical sciences
Full name of responsible person
Dr. Reza Bagheri
Position
MD
Other areas of specialty/work
Street address
qaem Hsp.
City
Mashhad
Postal code
098
Phone
+98 921 346 3752
Fax
Email
bagherir@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ebne sina st. Emam Reza hospital
Full name of responsible person
Reza Bagheri
Position
Other areas of specialty/work
Street address
Ebne sina st. Emam Reza hospital
City
Mashhad
Postal code
098
Phone
+98 921 346 3752
Fax
Email
bagherir@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)