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Effect of corticosteroids before rectal cancer surgery

A Randomized Controlled Trial of comparing Perioperative Dexamethasone or methylprednisolone with Placebo Effect on Excessive Postoperative Inflammatory Response and postoperative complications after rectal cancer surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241122063798N1
Enrollment
66
Registered
2025-11-16
Start date
2025-06-22
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer. Malignant neoplasm of rectum

Interventions

Intervention 1: Intervention Group 1: A single intravenous dose of 8 mg dexamethasone administered during anesthesia induction. The dexamethasone ampoule (8 mg in 2 mL) is manufactured by Osveh Pharma

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 18 - 80 Positive rectal cancer pathology Elective therapeutic surgery Obtaining informed consent

Exclusion criteria

Exclusion criteria: Steroid use contraindication On long-term corticosteroid therapy The American Society of Anesthesiologists (ASA) Physical Status Classification score greater than 3

Design outcomes

Primary

MeasureTime frame
C-Reactive Protein. Timepoint: One day before, and on days three and five after the intervention. Method of measurement: Latex agglutination test.;Interleukin 6. Timepoint: One day before, and on days three and five after the intervention. Method of measurement: ELISA.

Secondary

MeasureTime frame
3-year overall survival rate. Timepoint: Three years after the intervention. Method of measurement: Ask the individual, or the family in case of death.;Relapse. Timepoint: Three years after the intervention. Method of measurement: Ask the individual, or the family in case of death.;Quality of life. Timepoint: One day before, and 30 days after the intervention. Method of measurement: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire.;Post-operative complications index. Timepoint: 30 days after the intervention. Method of measurement: Checklist of Clavien Dindo Grade.;Post-operative complications index. Timepoint: 30 days after the intervention. Method of measurement: Comprehensive Complication Index Calculator.;Time to first passage of stool. Timepoint: 30 days after the intervention. Method of measurement: History taking.;Nausea. Timepoint: 30 days after the intervention. Method of measurement: History taking.;Vomiting. Timepoint: 30 days after the intervention. Method of measurement: History taking.;Surgical site infection. Timepoint: 30 days after the intervention. Method of measurement: History taking and examination.;Small bowel obstruction. Timepoint: 30 days after the intervention. Method of measurement: History taking and examination.;Pleural effusion. Timepoint: 30 days after the intervention. Method of measurement: History taking and examination and radiography.;Anastomotic leak. Timepoint: 30 days after the intervention. Method of measurement: History taking and examination and radiography.;Urinary tract infection. Timepoint: 30 days after the intervention. Method of measurement: History taking and urine culture.;Anemia. Timepoint: 30 days after the intervention. Method of measurement: Complete blood count.;Atelectasis. Timepoint: 30 days after the intervention. Method of measurement: History taking and chest X-Ray.;Length of hospital stay. Timepoint: 30 days after the intervention. Method of measurement: Patient's re

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtieh Mahmoudi

Iran University of Medical Sciences

atiyehmahmoudi5@gmail.com+98 21 8214 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026