Comparison of outcomes and complications between anterior repair, resection and hand sewn anastomosis, resection and stapled anastomosis of small intestine for reversal of loop ileostomy in patients who underwent rectal cancer resection surgery
To compare complications after surgery in three groups of anterior repair, resection and hand_sewn anastomosis and resection and stapled anastomosis.
Design
This is a prospective, randomized, double-blind clinical trial.
Settings and conduct
This study will be performed at the colorectal surgery division of department of surgery at Tehran University of Medical Sciences between January 27, 2023 and August 23, 2023.
Participants/Inclusion and 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.
Intervention groups
Intervention group A: 32 patients randomly selected and placed in the resection and hand sewn anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed with hand sewn.
Intervention group B : 32 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
Intervention group C: 32 patients randomly selected and placed in the resection and stapled anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed with stapler.
Main outcome variables
the first day of defecation / the first day of flatus / the first day of oral feeding / post operation early complications / post operation late complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120129008861N5
Registration date:2023-01-15, 1401/10/25
Registration timing:prospective
Last update:2023-01-15, 1401/10/25
Update count:0
Registration date
2023-01-15, 1401/10/25
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
Expected recruitment start date
2023-01-27, 1401/11/07
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes and complications between anterior repair, resection and hand sewn anastomosis, resection and stapled anastomosis of small intestine for reversal of loop ileostomy in patients who underwent rectal cancer resection surgery
Public title
Comparison between anterior repair, resection and hand sewn-anastomosis and resection and stapled anastomosis of small intestine for closure of loop ileostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a history of rectal cancer who had undergone curative low anterior resection for rectal cancer and a diverting protective loop ileostomy
Exclusion criteria:
history of immunodeficiency
complications associated with rectal anastomosis, including anastomotic leakage, para-anastomotic sinuses
previous abdominal operation
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
patients were randomly assigned into three groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants, Investigator and Outcome assessor , were blind to the study.
Before the surgery, the patients are randomly divided into three groups, which the patients and investigators do not know about it, and then the surgeon in the operating room is informed about the type of surgery of each patient, and the surgery is performed, and then the patients are transferred to the surgery ward. The patients are visited by the another surgeon ( investigator and outcome assessor) who is blind with the type of surgery of each patient and the information and data of the patients are collected and then the information is sent to the analyzer team.
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, research ethics committees of Imam Khomeini Hospital complex
Street address
6th floor, Central building of Tehran University of Medical Sciences, Ghods St., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1234567899
Approval date
2022-12-20, 1401/09/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1401.261
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: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then hand sewn anastomosis will be done.
Category
Treatment - Surgery
2
Description
Intervention group B : 32 patients randomly select and place in the anterior repair group. Anterior intestinal defect within the ileostomy site will be repaired.
Category
Treatment - Surgery
3
Description
Intervention group C: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then anastomosis will be done by the stapler.
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
Province
Tehran
Postal code
123454567890
Phone
+98 21 6119 0000
Email
mr-keramati@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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
Province
Tehran
Postal code
1234567890
Phone
+98 21 6119 0000
Email
mr-keramati@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Researach deputy, School of Medicine, Tehran 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
Persons
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/general surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 8860 7395
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2283 3381
Email
mr-keramati@razi.tums.ac.ir
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Khomeini hospital, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 2283 3381
Email
mr-keramati@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The result of this study will be presented in the form of an article.
When the data will become available and for how long
Information can be accessed at any time.
To whom data/document is available
All individuals.
Under which criteria data/document could be used
In scientific studies and clinical treatment of related patients.
From where data/document is obtainable
Colorectal Research Center of Imam Khomeini Hospital, Tehran University Of Medical Science. Contact the person in charge who is mentioned.
What processes are involved for a request to access data/document
Contact the colorectal center of the University of Tehran or contact the person in charge who is mentioned.