Protocol summary

Study aim
The aim of this study is to compare the performance and clinical outcome of three methods of colorectal anastomosis, Straight, Side to end, and J-Pouch methods in patients with colorectal cancer.
Design
This randomized, single-blind, parallel, clinical trial was performed during two years from March 2017 to September 2018 in Imam Khomeini Hospital (Sari, Iran) on 60 colorectal cancer patients. Sixty patients were randomly divided into three groups by randomly drawing sealed envelopes, using a computer-based table of randomization by a surgical assistant.
Settings and conduct
The demographic and clinical data were extracted from medical records and patients were followed up to evaluate functional characteristics of anastomotic methods.The participants, observer and data analyzer were not familiar with three types of anastomosis surgery in this study.However, the main researcher (surgeon) was informed about the groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria were as follows: all patients with 1) rectal adenocarcinoma, located 4 to 12 cm from anal verge who referring to Imam Khomeini Hospital in Sari from March 2017 to September 2018, 2) Complete medical documents 3) Possible oncological and functional sphincter preserving.The exclusion criteria were as follows: 1) Patients with incomplete documents, 2) continued treatment in other centers, 3) unavailable information 4) unknown tumor stage.
Intervention groups
Group A was undergone anterior resection with straight colorectal anastomosis (SA).group B was undergone colonic J-pouch (CJP) anastomosis. group C was undergone side-to-end colorectal anastomosis.
Main outcome variables
Demographic data (age, sex), Tumor characteristics were extracted from patients' documents and recorded in a questionnaire. Clinical performance evaluation was performed on the seventh day, the second month, and the sixth month.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141218020364N12
Registration date: 2019-05-25, 1398/03/04
Registration timing: retrospective

Last update: 2019-05-25, 1398/03/04
Update count: 0
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Mohhammad Yasin Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3839 1385
Email address
karamiy@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-01, 1395/12/11
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2018-08-01, 1397/05/10
Trial completion date
2019-04-21, 1398/02/01
Scientific title
Clinical outcomes of colonic J-pouch, straight colorectal and side-to-end anastomosis procedures in rectal cancer
Public title
Different anastomosis procedures in rectal cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Rectal adenocarcinoma, located 4 to 12 cm from anal verge Complete medical documents Possible oncological and functional sphincter preserving
Exclusion criteria:
Patients with incomplete documents, Continued treatment in other centers, Unavailable information Unknown tumor stage
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization of individual by randomly drawing sealed envelopes, using a computer-based table of randomization by a surgical assistant
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single-blind study, the participants were not familiar with three types of anastomosis surgery in this study. In addition, the observer, who completed the questionnaire, was not familiar with the groups. Similarly, the data analyzer did not know the study groups. However, the main researcher (surgeon) was informed about the groups, and all surgical procedures were performed by the same surgeon. The safety and data monitoring committee was also informed about the study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Valie Asr highway
City
Sari
Province
Mazandaran
Postal code
984815733971
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.018

Health conditions studied

1

Description of health condition studied
Colon Cancer
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon

2

Description of health condition studied
Rectal Cancer
ICD-10 code
C20
ICD-10 code description
Malignant neoplasm of rectum

Primary outcomes

1

Description
Surgery period
Timepoint
onset to end of anesthesia
Method of measurement
Minute

2

Description
Hospital Stay
Timepoint
Discharge Time
Method of measurement
day

3

Description
Blood Loss
Timepoint
ٍEnd of surgery
Method of measurement
CC

Secondary outcomes

1

Description
Defecation Frequency
Timepoint
ُSix months
Method of measurement
Normal, Frequently, More than 6 times

2

Description
Stool consistency
Timepoint
6 Month
Method of measurement
Normal, Loose, Liquid

3

Description
Stool Leakage
Timepoint
6 month
Method of measurement
No, Diarrhea, Always

4

Description
Sense of urgency
Timepoint
6 month
Method of measurement
Normal , Short

5

Description
Difficult defecation
Timepoint
6 month
Method of measurement
Yes, No

Intervention groups

1

Description
Intervention group1: Coloanal End to End Anastomosis
Category
Treatment - Surgery

2

Description
Intervention group 2: Side to End Anastomosis
Category
Treatment - Surgery

3

Description
Intervention group 3: J poach coloanal anastomosis
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mina Alvandipoor
Street address
Razi Ave
City
Sari
Province
Mazandaran
Postal code
984816633131
Phone
+98 11 3336 1700
Email
Minaalvh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Mazandaran University of Medical Sciences, Joybar three ways
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 9815
Email
saeidimajid@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohhammad Yasin Karami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Faghighi Hospital
City
Shiraz
Province
Fars
Postal code
4815733971
Phone
+98 71 3839 1385
Fax
+98 71 3233 0724
Email
karamiy@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohhammad Yasin Karami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Faghighi Hospital
City
Shiraz
Province
Fars
Postal code
4815733971
Phone
+98 71 3839 1385
Fax
+98 71 3233 0724
Email
karamiy@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohhammad Yasin Karami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Faghighi Hospital
City
Shiraz
Province
Fars
Postal code
4815733971
Phone
+98 71 3839 1385
Fax
+98 71 3233 0724
Email
karamiy@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is not a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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