NCT07398716Completed
Intraoperative Assessment of Distal Resection Margins Using Frozen Section in Mid and Low Rectal Cancer Surgery
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
This study aims to improve the safety of distal surgical margins in patients with middle and low rectal cancer who receive neoadjuvant radiotherapy. Although magnetic resonance imaging and colonoscopic evaluation after neoadjuvant radiotherapy may suggest complete or near-complete tumor regression, residual tumor cells can still be present in the submucosal and muscular layers of the rectal wall. This may increase the risk of inadequate surgical margins and local recurrence. In this study, patients with middle and low rectal cancer who are scheduled for surgery after neoadjuvant radiotherapy will be randomized into two groups. In the frozen section group, intraoperative frozen section analysis of the resection specimen will be performed immediately after specimen removal to assess the distal resection margin, and the surgical procedure will be guided according to the frozen section results. In the control group, standard surgical resection will be performed without intraoperative frozen section evaluation. Pathological findings, distal margin status, operative time, tumor stage, and recurrence during follow-up will be compared between the two groups to evaluate the impact of intraoperative frozen section analysis on surgical margin safety and oncological outcomes.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 25 Jan 2026
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Jan 2025
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT07398716
What you commit to
- Study type: Interventional
- Participants enrolled: 99
- From 1 Jan 2022 to the primary completion date, 1 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing emergency surgery
- Patients planned for local excision or palliative surgery
- Patients with a history of previous rectal surgery
Other illness
- Stage IV rectal cancer
Other
- Upper rectal tumors
- Patients with distant metastasis
Who the study is looking for
- Patients diagnosed with mid or low rectal cancer (Stage I-III)
- Patients who have received short-course or long-course neoadjuvant radiotherapy
- Patients evaluated and approved for surgery by a multidisciplinary oncology board
- Patients scheduled for total mesorectal excision (TME)
- Age ≥ 18 years
- Patients who provide written informed consent
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bakırköy Dr. Sadi Konuk Training and Research Hospital Coordinator of this site? Confirm its status | Bakırköy | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.