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NCT Number: NCT06359730

Incidence and Risk Factors of Low Anterior Resection Syndrome

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University Hospitals

Zagazig, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • • 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)

Treatment and study plan

LARS score questionnaire

Other

LARS score questionnaire is filled by the patient after anterior resection for rectal cancer to study the quality of life

Primary outcomes

  1. age

    Time frame: from 2017 to 2022

    age of the patients in years was recorded from patient records

  2. sex

    Time frame: from 2017 to 2022

    sex of patients was recorded from patient records

  3. medical disease

    Time frame: from 2017 to 2022

    medical disease like diabetes and hypertension was recorded from patient records

  4. site of tumor

    Time frame: from 2017 to 2022

    tumor site was determined in Cm from anal verge by colonoscopy

  5. neoadjuvant therapy

    Time frame: from 2017 to 2022

    history of neoadjuvant therapy before surgery was obtained from patients records

  6. site of anastmosis

    Time frame: from 2017 to 2022

    site of anastmosis after resection was recorded as colo-rectal or colo-anal

  7. type of meso-rectal excision

    Time frame: from 2017 to 2022

    excision of meso-rectum was recorded if it was partial or complete

  8. adjuvant therapy

    Time frame: from 2017 to 2022

    it was recorded from patients records if he\\she had chemo- or radiotherapy post-operatively

  9. type of surgery

    Time frame: from 2017 to 2022

    from records; surgery was open or laparoscopic

  10. type of anastmosis

    Time frame: from 2017 to 2022

    type of anastmosis(hand sewen or stappled) obtained from records

  11. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Incidence, Risk Factors Of Low Anterior Resection Syndrome And Validation Of LARS Score Among Egyptian Patients

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2024
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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