Determining the effect of glycerol and sodium pentaburoate formulation in preventing postoperative pritoneal adhesion
Design
A concealed, phase 2, randomized, triple blinded, controlled clinical trial with a parallel group design of 40 patients. RAS (Random Aloocation Sofware) software was used to randomize.
Settings and conduct
40 adults aged 20 to 60 years who need laparotomy for a second look surgery for reverse colostomy or ileostomy will be included in the study and randomly allocated into two groups 1. Intervention (washing the peritoneal area with 100 ml of 3% glycerol and sodium pentaborate 3% formulation at the beginning and end of surgery) and 2. Placebo (washing the peritoneal area with 100 ml of normal saline at the beginning and end of surgery). To concealment the allocation, similar sealed envelopes will be used in a matte package that is numbered one after the other. Main investigators, participants and outcome evaluators will be blind to the random allocation of groups.
Participants/Inclusion and exclusion criteria
Age of 20-60 years and needing laparotomy for reverse colostomy or ileostomy surgery
Intervention groups
Intervention group:Wash the peritoneal area with 100 ml of 3% glycerol and 3% sodium pentaborate formulation at the beginning and end of surgery.
Control group: Wash the peritoneal area with 100 ml of normal saline at the beginning and end of surgery
Main outcome variables
Microscopic peritoneal adhesion and gross peritoneal adhesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043923N5
Registration date:2020-05-09, 1399/02/20
Registration timing:prospective
Last update:2020-05-09, 1399/02/20
Update count:0
Registration date
2020-05-09, 1399/02/20
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 1928
Email address
aghamohammadi.d@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of glycerol and sodium pentaborate formulation on prevention of postoperative peritoneal adhesion formation
Public title
Glycerol and sodium pentaborate in prevention of postoperative peritoneal adhesion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20-60 years
Need laparotomy for reverse colostomy or ileostomy surgery
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS) with block sizes of 2 and 4. Similar sealed envelopes will be used to conceal the allocation in a sequentially numbered opaque package
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, main investigators, physicians in charge of patient care, data collection authorities, those who evaluate the outcome, those who perform the statistical analysis of the data, and those who prepare the draft of the manuscript will be blind to the random allocation of patients.
Placebo
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