History
# Registration date Revision Id
2 2022-06-21, 1401/03/31 231145
1 2017-05-08, 1396/02/18 9335
Changes made to previous revision
This is the first revision

Protocol summary

Summary
Loop ileostomy is a major surgical procedure suggested to control the complications of colorectal anastomosis, especially disruption and anastomosis leakage in patients undergoing resection of the distal rectum cancers. This trial is done to compare two methods of anterior repair and resection and anastomosis of the small intestine for ileostomy closure. For a better and more accurate comparison, we decided to perform the clinical trial in two randomized groups of 20 patients to answer the research questions. Goals: To compare complications after surgery in two groups of anterior repair and resection and anastomosis. These complications include early complications such as anastomosis leakage, infection, bleeding, in addition to late complications such as anastomosis stricture and obstruction. Method and participants: This study is a randomized clinical trial in two groups of 20 patients who underwent LAR surgery for rectal cancer and protective loop ileostomy. Intervention: Patients in two groups were randomly assigned. The first group underwent intestinal resection in the distal and proximal part of ileostomy and then an hand-sewn anastomosis was done. In the second group the anterior defect within the ileostomy was repaired. Main outcomes : first day of defecation / first day of flatus / first day of oral feeding / post operation early complications / post operation late complications

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201703158861N2
Registration date: 2017-05-08, 1396/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 1
Registration date
2017-05-08, 1396/02/18
Registrant information
Name
Mohammad Reza Keramati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1657
Email address
mr-keramati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes and complications between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy performed in patients underwent rectal cancer resetion surgery
Public title
Comparison between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with history of rectal cancer underwent low anterior resection surgery with protective loop ileostomy. Exclusion criteria immune deficiency; rectal anastomosis complications; history of abdominal surgery except rectal surgery.
Age
From 15 years old
Gender
Both
Phase
N/A
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
Tehran University of Medical Sciences
Street address
6th floor, Central building of Tehran University of Medical Sciences, Ghods St., Keshavarz blvd.
City
Tehran
Postal code
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.494

Health conditions studied

1

Description of health condition studied
Function of bowel
ICD-10 code
K59.9
ICD-10 code description
Functional intestinal disorder, unspecified

Primary outcomes

1

Description
the first day of defecation
Timepoint
daily up to one week
Method of measurement
question from the patient in daily ward visits

2

Description
the first day of flatus
Timepoint
daily up to one week
Method of measurement
question from the patient in daily ward visits

3

Description
the first day of oral feeding
Timepoint
daily up to one week
Method of measurement
stariting of oral diet based on surgeons decision

4

Description
post operation early complications
Timepoint
daily up to one month
Method of measurement
question from the patient in daily ward visits

5

Description
post operation late complications
Timepoint
monthly up to 6 months
Method of measurement
question from the patient in monthly clinic visits

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed.
Category
Treatment - Surgery

2

Description
Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, Imam Khomeini Hospital
Full name of responsible person
Dr. Mohammad Reza Keramati
Street address
Imam Khomeini Hospital, Keshavarz blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Researach deputy, School of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Faculty of Medicine, Poor-sina St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researach deputy, School of Medicine, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Mostafa Meshkati Yazd
Position
MD/ Resident of surgery
Other areas of specialty/work
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 8860 7395
Fax
Email
mostafa.meshkati@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Keramati
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 2283 3381
Fax
Email
mr-keramati@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Keramati
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 2283 3381
Fax
Email
mr-keramati@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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