Protocol summary
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Study aim
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To compare complications after surgery in two groups of anterior repair versus resection and hand_sewn anastomosis.
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Design
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This is a prospective, randomized, double-blind clinical trial.
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Settings and conduct
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This study was performed at the colorectal surgery division of department of surgery at Tehran University of Medical Sciences between September 1, 2016 and December 1, 2018.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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. Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
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Main outcome variables
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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
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Reason for update
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In this study, participants, collectors of results and analyzers, were blind to the study. Wrongly، single-blind study was entered that should be corrected to double-blind study.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201703158861N2
Registration date:
2017-05-08, 1396/02/18
Registration timing:
registered_while_recruiting
Last update:
2022-06-25, 1401/04/04
Update count:
1
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Registration date
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2017-05-08, 1396/02/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tehran University of Medical Sciences
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Expected recruitment start date
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2016-09-01, 1395/06/11
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Expected recruitment end date
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2017-07-01, 1396/04/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Comparison between anterior repair and resection-anastomosis of small intestine for closure of loop ileostomy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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 other than rectal cancer surgery
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Age
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From 15 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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patients were randomly assigned into two groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this double-blind study, participants, collectors of results and analyzers, were blind to the study.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-08-27, 1395/06/06
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Ethics committee reference number
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IR.TUMS.VCR.REC.1395.494
Health conditions studied
1
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Description of health condition studied
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Function of bowel
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ICD-10 code
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K59.9
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ICD-10 code description
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Functional intestinal disorder, unspecified
Primary outcomes
1
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Description
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the first day of defecation
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Timepoint
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daily up to one week
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Method of measurement
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question from the patient in daily ward visits
2
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Description
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the first day of flatus
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Timepoint
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daily up to one week
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Method of measurement
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question from the patient in daily ward visits
3
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Description
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the first day of oral feeding
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Timepoint
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daily up to one week
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Method of measurement
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stariting of oral diet based on surgeons decision
4
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Description
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post operation early complications
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Timepoint
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daily up to one month
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Method of measurement
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question from the patient in daily ward visits
5
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Description
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post operation late complications
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Timepoint
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monthly up to 6 months
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Method of measurement
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question from the patient in monthly clinic visits
Intervention groups
1
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Description
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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.
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Category
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Treatment - Surgery
2
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Description
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Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Researach deputy, School of Medicine, Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The result of this study will be presented in the form of an article.
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When the data will become available and for how long
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Information can be accessed at any time.
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To whom data/document is available
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All individuals.
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Under which criteria data/document could be used
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In scientific studies and clinical treatment of related patients.
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From where data/document is obtainable
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Colorectal Research Center of Imam Khomeini Hospital, Tehran University Of Medical Science.
Contact the person in charge who is mentioned.
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What processes are involved for a request to access data/document
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Contact the colorectal center of the University of Tehran or contact the person in charge who is mentioned.
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Comments
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