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Intraoperative Assessment of Distal Resection Margins Using Frozen Section in Mid and Low Rectal Cancer Surgery

NCT07398716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-02-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Intraoperative Frozen Section Assessment

Intraoperative pathological evaluation of distal resection margins using frozen section to guide surgical decision-making.

PROCEDURE

Standard Surgery Without Frozen Section

Standard surgical resection without intraoperative frozen section assessment of distal margins.

Sponsors & Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    lead OTHER_GOV

Principal Investigators

  • Nurettin Sahin, MD · Bakırköy Dr. Sadi Konuk Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-01-01
Completion
2026-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398716 on ClinicalTrials.gov