Protocol summary

Study aim
Comparison of postoperative outcomes of prone, semi-prone and lateral decubitus positions in thoracoscopic-laparoscopic esophagectomy of patients with esophageal cancer referred to Imam Reza hospital between 2018-2020
Design
A clinical trial with 3 groups, randomized, single-blind, on 51 patients using simple random sampling method.
Settings and conduct
In this clinical trial study, 51 patients with cancer referred to Imam Reza (AS) hospital in Tabriz between 2018-2020, who are willing to undergo upper endoscopy and biopsy and approved, will be included in the study. Staging and surgical intervention in patients will be performed by CT-Scan with chest and abdomen contrast and bronchoscopy (for middle third tumors). For all Chest X-Ray patients, lung function tests, ECG and cardiovascular function will be performed. The surgeon will not know the type of position before entering the operating room, and upon entering the operating room, the relevant nurse will randomly announce the type of surgical position to the surgeon based on the list prepared and those who evaluate the consequences of surgery will not know the type of position and goals of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction to participate in the study and esophageal cancer Exclusion criteria: Sensitivity to anesthetics and impossibility of anesthesia and death of the patient during surgery
Intervention groups
Patients will be randomly divided into 3 groups: prone position, semi-prone position and lateral decubitus. Patients will then undergo MIE.
Main outcome variables
Intraoperative variables (duration of surgery, rate of blood loss, likelihood of change to open surgery) and postoperative variables (mortality, morbidity: respiratory complications, esophagogastric anastomotic leakage, thoracic duct injury, hoarseness)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200703047990N1
Registration date: 2020-08-25, 1399/06/04
Registration timing: retrospective

Last update: 2020-08-25, 1399/06/04
Update count: 0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Hossein Ostadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3440 5872
Email address
hostadi2005@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
2019-10-23, 1398/08/01
Actual recruitment end date
2020-04-20, 1399/02/01
Trial completion date
2020-04-20, 1399/02/01
Scientific title
A comparison of perioperative short outcomes between patients' different positions in thoracoscopic-laparoscopic esophagectomy for patients with esophageal cancer th esophageal cancer
Public title
Evaluation of three methods of thoracoscopic-laparoscopic esophagectomy in esophageal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Having esophageal cancer
Exclusion criteria:
Allergy to anesthetics Inability to anesthetize the patient
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 50
Actual sample size reached: 51
Randomization (investigator's opinion)
Randomized
Randomization description
We selected 51 patients from 150 patients using a random number table. ّFor this, each patient was assigned a three-digit code, then 3 groups were selected randomly using random numbers table by closed eyes. First we assigned the selected numbers to the first group, then to the second group and reminders go to the third group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The surgeon is not aware of the patient's position before the operation
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No. 15, Varzesh Ave, Dampezeshki Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5183838436
Approval date
2020-06-06, 1399/03/17
Ethics committee reference number
IR.TBZMED.REC.1399.317

Health conditions studied

1

Description of health condition studied
Esophageal cancer
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood loss
Timepoint
Immediately after and 24 hours after surgery
Method of measurement
milliliter

2

Description
Surgical satisfaction(Probability of change to open surgery)
Timepoint
After the intervention
Method of measurement
Satisfaction Questionnaire

3

Description
Duration of surgery
Timepoint
Before the intervention until the end of surgery
Method of measurement
The number of hours surgery takes

4

Description
Mortality
Timepoint
After the intervention
Method of measurement
check list

5

Description
Morbidity
Timepoint
After the intervention
Method of measurement
check list

6

Description
respiratory complications
Timepoint
after surgery
Method of measurement
clinical assesment and imaging

7

Description
leak of esophagogastric anastomosis
Timepoint
after surgery
Method of measurement
clinical assesment and imaging

8

Description
thoracic duct injury
Timepoint
after surgery
Method of measurement
clinical assesment

9

Description
hoarsness
Timepoint
after surgery
Method of measurement
clinical assesment

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: prone position
Category
Treatment - Surgery

2

Description
Intervention group: semi prone position
Category
Treatment - Surgery

3

Description
Intervention group: lateral decubitus
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Hosein Ostadi
Street address
No. 15, Varzesh Ave, Dampezeshki Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5183838436
Phone
+98 41 3440 5872
Email
hostadi2005@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Ostadi
Street address
No. 15, Varzesh Ave, Dampezeshki Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5183838436
Phone
+98 41 3440 5872
Email
hostadi2005@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Ostadi
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No. 15, Varzesh Ave, Dampezeshki Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5183838436
Phone
+98 41 3440 5872
Email
hostadi2005@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Ostadi
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No. 15, Varzesh Ave. Dampezeshki Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5183838436
Phone
+98 41 3440 5872
Email
hostadi2005@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hosein Ostadi
Position
Non-faculty specialist
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
No. 15, Varzesh Ave. Dampezeshki Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5183838436
Phone
+98 41 3440 5872
Email
hostadi2005@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Scientific research use
From where data/document is obtainable
For information, please contact hostadi2005@gmail.com and call 09144143697 in the name of Mr. Hossein Ostadi.
What processes are involved for a request to access data/document
3 to 6 months after receiving the request
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