Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience

Colorectal Cancer Clinical Trial

Official title:

Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06325410
• Other study ID #: #11279-20-11-2023
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Recurrence

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