Clinical trial · Interventional
Intraoperative Assessment of Distal Resection Margins Using Frozen Section in Mid and Low Rectal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Frozen Section Assessment | Procedure | — | UNRESOLVED |
| Standard Surgery Without Frozen Section | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intraoperative Frozen Section Group
- description
- Patients undergo total mesorectal excision followed by intraoperative colonoscopy. After specimen removal, distal resection margins are assessed using intraoperative frozen section by an expert pathologist. Additional resection is performed if margins are positive or less than 1 cm. Abdominoperineal resection is performed if a safe margin cannot be achieved.
- interventionNames
- Procedure: Intraoperative Frozen Section Assessment
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Patients undergo total mesorectal excision followed by intraoperative colonoscopy. Resection is performed 2 cm distal to the tumor using a stapler, and anastomosis is completed without intraoperative frozen section assessment.
- interventionNames
- Procedure: Standard Surgery Without Frozen Section
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Stage IV rectal cancer * Upper rectal tumors * Patients undergoing emergency surgery * Patients planned for local excision or palliative surgery * Patients with distant metastasis * Patients with a history of previous rectal surgery
References
Publications (2)
- RESULTGomes RM, Bhandare M, Desouza A, Bal M, Saklani AP. Role of intraoperative frozen section for assessing distal resection margin after anterior resection. Int J Colorectal Dis. 2015 Aug;30(8):1081-9. doi: 10.1007/s00384-015-2244-4. Epub 2015 May 16. PMID 25982468
- RESULTKhoury W, Abboud W, Hershkovitz D, Duek SD. Frozen section examination may facilitate reconstructive surgery for mid and low rectal cancer. J Surg Oncol. 2014 Dec;110(8):997-1001. doi: 10.1002/jso.23758. Epub 2014 Sep 2. PMID 25183166