Colorectal CancerNCT06359730
Incidence and Risk Factors of Low Anterior Resection Syndrome
An observational study of Colorectal Cancer, run by Zagazig University at 1 site in Egypt.
Trial summary
Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome. With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- LARS score questionnaire
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients who had anterior resection surgery for rectal carcinoma
Who may be able to join
- Age more than 18
- Diagnosed patients with rectal adenocarcinoma and who received low anterior resection with anastomosis creation or after a minimum 6 months interval after stoma reversal.
- Tumors of the rectum (2-15 cm) from anal verge
Who cannot join
- • cognitive dysfunction
- Having a history of inflammatory bowel disease or any disease with bowel function impairment namely, Crohn's disease, irritable bowel syndrome, ulcerative colitis or others.
- Age less than 18
- Metastatic cancer or tumor recurrence
- Rectal tumors within 2 cm from anal verge( abdominoperineal)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Risk Factors Of Low Anterior Resection Syndrome And Validation Of LARS Score Among Egyptian Patients
Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.
With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.
- Conditions
- Colorectal Cancer
- Being tested
- LARS score questionnaire
- Keywords
- rectal cancer, anterior resection, LARS
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARS score questionnaireOther
LARS score questionnaire is filled by the patient after anterior resection for rectal cancer to study the quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
age
age of the patients in years was recorded from patient records
Measured: from 2017 to 2022
sex
sex of patients was recorded from patient records
Measured: from 2017 to 2022
medical disease
medical disease like diabetes and hypertension was recorded from patient records
Measured: from 2017 to 2022
site of tumor
tumor site was determined in Cm from anal verge by colonoscopy
Measured: from 2017 to 2022
neoadjuvant therapy
history of neoadjuvant therapy before surgery was obtained from patients records
Measured: from 2017 to 2022
site of anastmosis
site of anastmosis after resection was recorded as colo-rectal or colo-anal
Measured: from 2017 to 2022
type of meso-rectal excision
excision of meso-rectum was recorded if it was partial or complete
Measured: from 2017 to 2022
adjuvant therapy
it was recorded from patients records if he\she had chemo- or radiotherapy post-operatively
Measured: from 2017 to 2022
type of surgery
from records; surgery was open or laparoscopic
Measured: from 2017 to 2022
type of anastmosis
type of anastmosis(hand sewen or stappled) obtained from records
Measured: from 2017 to 2022
LARS score
obtained by LARS questionnaire filled by the patient during follow up, it was formed of five questions with different scores on answer choices, interpretaion (0-20) means no LARS, (21- 29) means minor LARS, (30-42) means major LARS
Measured: from 2017 to 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Dec 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
- Investigators
- Reham Zakaria, PhD, Principal investigator, faculty of medicine Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359730
- Sponsor's protocol ID
- 253/26-March-2024
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with other researchers on demand by e- mailing the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors Of Low Anterior Resection Syndrome And Validation Of LARS Score Among Egyptian Patients
- ClinicalTrials.gov ID
- NCT06359730
- Acronym / sponsor ID
- 253/26-March-2024
- Conditions
- Colorectal Cancer
- Keywords
- rectal cancer, anterior resection, LARS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.
With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients who had anterior resection surgery for rectal carcinoma
Key inclusion criteria (3 listed)
- Age more than 18
Key exclusion criteria (5 listed)
- • cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LARS score questionnaireLARS score questionnaire is filled by the patient after anterior resection for rectal cancer to study the quality of life | Other | – |
Primary outcome
age
Time frame: from 2017 to 2022
age of the patients in years was recorded from patient records
sex
Time frame: from 2017 to 2022
sex of patients was recorded from patient records
medical disease
Time frame: from 2017 to 2022
medical disease like diabetes and hypertension was recorded from patient records
site of tumor
Time frame: from 2017 to 2022
tumor site was determined in Cm from anal verge by colonoscopy
neoadjuvant therapy
Time frame: from 2017 to 2022
history of neoadjuvant therapy before surgery was obtained from patients records
site of anastmosis
Time frame: from 2017 to 2022
site of anastmosis after resection was recorded as colo-rectal or colo-anal
type of meso-rectal excision
Time frame: from 2017 to 2022
excision of meso-rectum was recorded if it was partial or complete
adjuvant therapy
Time frame: from 2017 to 2022
it was recorded from patients records if he\she had chemo- or radiotherapy post-operatively
type of surgery
Time frame: from 2017 to 2022
from records; surgery was open or laparoscopic
type of anastmosis
Time frame: from 2017 to 2022
type of anastmosis(hand sewen or stappled) obtained from records
LARS score
Time frame: from 2017 to 2022
obtained by LARS questionnaire filled by the patient during follow up, it was formed of five questions with different scores on answer choices, interpretaion (0-20) means no LARS, (21- 29) means minor LARS, (30-42) means major LARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No. IPD will be shared with other researchers on demand by e- mailing the principle investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Zakaria, PhD principal investigator
faculty of medicine Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
age (time frame: from 2017 to 2022). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.