Assessing the outcomes of drain insertion in open versus laparoscopic splenectomy or splenorrhaphy in patients who are candidate for spleen surgery: a clinical trial
Objectives: To assess the outcomes of drain insertion in open versus laparoscopic splenectomy or splenorrhaphy in patients who are candidate for spleen surgery.
Design: a clinical trial.
Setting and conduct: The eligible patients who are candidate for spleen surgery will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Candidate for spleen surgery
Intervention group: Laparoscopic splenectomy or splenorrhaphy.
Control group: Open splenectomy or splenorrhaphy.
Primary outcome: (a) dehiscence during the first five days after surgery through clinical examination; (b) surgical wound infection during the first five days after surgery through clinical examination; (c) accumulation of non-purulent discharge on the surgical side during the first five days after surgery through clinical examination; (d) formation of sub-diaphragmatic abscess on the fifth day after surgery through CT-scan.
Randomization: Non-randomized.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612059014N136
Registration date:2016-12-23, 1395/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-23, 1395/10/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the outcomes of drain insertion in open versus laparoscopic splenectomy or splenorrhaphy in patients who are candidate for spleen surgery: a clinical trial
Public title
Assessing the outcomes of drain insertion in open versus laparoscopic splenectomy or splenorrhaphy in patients who are candidate for spleen surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for spleen surgery
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Non-randomized.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-05-11, 1395/02/22
Ethics committee reference number
IR.UMSHA.REC.1395.123
Health conditions studied
1
Description of health condition studied
candidate for spleen surgery
ICD-10 code
S36.0
ICD-10 code description
Injury of spleen
Primary outcomes
1
Description
dehiscence
Timepoint
during the first five days after surgery
Method of measurement
through clinical examination
2
Description
surgical wound infection
Timepoint
during the first five days after surgery
Method of measurement
through clinical examination
3
Description
accumulation of non-purulent discharge on the surgical side
Timepoint
during the first five days after surgery
Method of measurement
through clinical examination
4
Description
formation of sub-diaphragmatic abscess
Timepoint
on the fifth day after surgery
Method of measurement
through CT-scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Laparoscopic splenectomy or splenorrhaphy.
Category
Treatment - Surgery
2
Description
Control group: Open splenectomy or splenorrhaphy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Vahid Hamzei
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Dr Vahid Hamzei
Position
Resident of Urology
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
dr_hamzei8007@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Mahdi Eskandarlou
Position
Urologist
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
dr.eskandarlou@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)