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Comparative study of two surgical methods: open and laparoscopic in upper and middle rectal cancer and its outcomes.

Comparative study of two surgical methods, laparotomy and laparoscopic, for upper and middle rectal cancer on functional intestinal, sexual, urinary outcomes and quality of life of patients; Randomized clinical trial study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250908067174N4
Enrollment
208
Registered
2026-01-24
Start date
2026-02-04
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.

Interventions

Intervention 1: Intervention group: Open Upper Rectal Cancer Surgery Group. Intervention 2: Intervention group: Laparoscopic surgery group for upper rectal cancer. Intervention 3: Intervention group:

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 45 years old Upper and middle rectal cancer must be definitively diagnosed based on preoperative imaging results. Patients must be in stages 2 and 3 of upper and middle rectal cancer staging based on the TNM system. No history of surgery in the colon, rectum, or prostate area. No cancer metastasis to surrounding or distant organs (prostate, uterus, vagina, liver, lungs) Patients should not have urinary problems, such as stress incontinence and neuromuscular diseases that affect sphincter function. No history of lumbar disc surgery or any spinal cord injury that causes urinary, sexual, or bowel dysfunction. Not having inflammatory bowel diseases such as ulcerative colitis

Exclusion criteria

Exclusion criteria: Disease progression or recurrence: Patients who experience significant disease progression or recurrence during the waiting period until surgery. Non-compliance with the study protocol: Patients who fail to fully comply with the study protocol, including failure to complete questionnaires on time, failure to perform necessary tests, or failure to attend treatment sessions and follow-ups.

Design outcomes

Primary

MeasureTime frame
Intestinal function. Timepoint: One week before surgery and 1, 3, and 6 months after surgery. Method of measurement: Low Anterior Resection Syndrome (LARS) Questionnaire.;Urinary symptoms. Timepoint: One week before surgery and 1, 3, and 6 months after surgery. Method of measurement: International Prostate Symptom Score(IPSS) in Men, ICIQ-FLUTS in Women.;Sexual function. Timepoint: One week before surgery and 1, 3, and 6 months after surgery. Method of measurement: Female Sexual Function Questionnaire (FSFI) and International Index of Erectile Function (IIEF) in men.;Quality of life. Timepoint: One week before surgery and 1, 3, and 6 months after surgery. Method of measurement: Colorectal Cancer Quality of Life Questionnaire Appendix 29 QLQ-CR.

Secondary

MeasureTime frame
Pain. Timepoint: One day, two weeks, and one month after surgery. Method of measurement: Visual analog scale.;Bleeding. Timepoint: One day, two weeks, and one month after surgery. Method of measurement: The amount of blood collected in the suction bottle and the method of accurately weighing gases during the operation and measuring the discharge from the drainage tubes after the operation.;Surgery Time. Timepoint: During surgery. Method of measurement: Stopwatch and in minutes.;Fecal incontinence. Timepoint: One month, three months, and six months after the operation. Method of measurement: Wexner Fecal Incontinence Scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRohollah Taghavi

Hamedan University of Medical Sciences

fateme1380samiee@gmail.com+98 25 3212 2200

Outcome results

None listed

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