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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06325410
Other study ID # #11279-20-11-2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date December 2022

Study information

Verified date March 2024
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University. Data was collected from records in a retrospective cohort study


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 2022
Est. primary completion date December 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients with newly diagnosed colorectal cancer - Age > 18 years old - recurrent cases of colorectal cancer Exclusion Criteria: - Pediartric patient less than 18 yr - In operable or metastatic cancer colon - No other malignancies

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
resection of colorectal cancer
resection of bowel segment and re-anastmosis or stoma formation

Locations

Country Name City State
Egypt Zagazig University Hospitals Zagazig

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary age age of patients was obtained from medical records through study completion, an average of 5 years
Primary sex sex of patients was obtained from medical records through study completion, an average of 5 years
Primary medical disease co-existing medical disease was obtained from medical records through study completion, an average of 5 years
Primary previous surgery previous surgical history was obtained from medical records through study completion, an average of 5 years
Primary CEA value of carcino-embryonic antigen was recorded through study completion, an average of 5 years
Primary tumor grade tumor grade after resection from pathology report recorded through study completion, an average of 5 years
Primary tumor site tumor site recorded from operative findings through study completion, an average of 5 years
Primary tumor size tumor size was measured by length x width in cm from records through study completion, an average of 5 years
Primary surgical margins of resected tumor safety margins were assessed from pathological examination under microscopy and recorded in pathology reports, it can be free surgical margins ( no tumor cells) or positive surgical margins( presence of tumor cells) through study completion, an average of 5 years
Primary neoadjuvant therapy history of neoadjuvant therapy before surgery from records obtained through study completion, an average of 5 years
Primary adjuvant therapy history of adjuvant therapy post operative obtained from records through study completion, an average of 5 years
Primary diet diet and dietary life style from history through study completion, an average of 5 years
Primary occupation occupation of the patient at time of surgery and if it was changed through study completion, an average of 5 years
Primary family history history taking of family history of cancer disease through study completion, an average of 5 years
Primary type of surgery(laparoscopic or open) type of operation was laparoscopic or open surgery obtained from records through study completion, an average of 5 years
Primary soiling by during surgery by history from records if there was soiling of the field by tumor cells through study completion, an average of 5 years
Primary hand sewen or stappled anastmosis if there was bowel re-anastmosis after surgery, it was done using a stappler or hand sewing sutures. this was obtained from operative data in patient records through study completion, an average of 5 years
Primary post operative complications from records; if there were post operative complication like fecal fistula through study completion, an average of 5 years
Primary site of recurrence site of tumor recurrence was detected through study completion, an average of 5 years
Primary type of resected tumor type of tumor was recorded from pathology reports through study completion, an average of 5 years
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