Clinical trial · Interventional
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial, From 2025 to 2027
NCT07190638CI-TRIAL-00095686CORTEXrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Renal function preservation is a growing concern in the surgical management of kidney tumors, particularly with the rise in chronic kidney disease worldwide. Recent surgical innovations have focused on modifying renorrhaphy techniques to minimize renal damage. Emerging evidence suggests that omitting cortical suturing may reduce operative time, blood loss, and renal parenchymal loss without increasing major complications. This randomized controlled trial aims to compare outcomes between medullary-only and combined cortical-medullary suture techniques during robot-assisted partial nephrectomy, with the goal of identifying the approach that best balances functional preservation and surgical safety.
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 |
|---|---|---|---|
| RCC, Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hemostatic Agent | Device | — | UNRESOLVED |
| Medullary and cortical suturing (two-layer) | Procedure | — | UNRESOLVED |
| Medullary-only suturing (single-layer) | Procedure | — | UNRESOLVED |
| Suture | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Medullary-only suturing (single-layer)
- description
- After partial nephrectomy, only the medullary layer is sutured using a running 3-0 synthetic absorbable monofilament suture (Caproyl™). The cortical layer is not sutured. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to support hemostasis.
- interventionNames
- Procedure: Medullary-only suturing (single-layer)
- Device: Suture
- Device: Hemostatic Agent
- type
- ACTIVE_COMPARATOR
- label
- Medullary and cortical suturing (two-layer)
- description
- After partial nephrectomy, both the medullary and cortical layers are sutured. The medullary layer is closed with a running 3-0 Caproyl™ suture before unclamping. Then, the cortical layer is sutured with 0 Vicryl™ using a running technique. Hemostatic agents, such as Bleed Stp Plus, Surgicel® Fibrillar, or Hemopatch®, may be applied to assist in bleeding control.
- interventionNames
- Procedure: Medullary and cortical suturing (two-layer)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of renal mass confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) * Indication for partial nephrectomy * Written informed consent * Expected survival of at least 6 months * Eastern Cooperative Oncology Group (ECOG) score performance status ≤ 1 * Negative serum or urine pregnancy test within 24 hours before surgery for women of childbearing potential * Recovery from any prior therapy-related toxicity to grade 1 or better * If a biopsy has been performed, pathology consistent with renal cell carcinoma (RCC) Exclusion Criteria: * Solitary kidney * Multiple or bilateral renal masses if more than one mass is operated on simultaneously or within less than 4 months * Hepatic or renal toxicity grade ≥ 2 with glomerular filtration rate (GFR) \< 30 according to Common Terminology Criteria for Adverse Events (CTCAE v4) * Bleeding diathesis * Inability to maintain anticoagulation for surgery * Participation in another experimental trial simultaneously or within 30 days prior to enrollment * Significant acute or chronic medical, neurological, or psychiatric condition that could compromise safety, limit study completion, or impair study objectives in the opinion of the Principal Investigator
References
Publications (12)
- BACKGROUNDWilliams RD, Snowden C, Frank R, Thiel DD. Has Sliding-Clip Renorrhaphy Eliminated the Need for Collecting System Repair During Robot-Assisted Partial Nephrectomy? J Endourol. 2017 Mar;31(3):289-294. doi: 10.1089/end.2016.0562. Epub 2017 Jan 16. PMID 27960537
- BACKGROUNDArora S, Bronkema C, Porter JR, Mottrie A, Dasgupta P, Challacombe B, Rha KH, Ahlawat RK, Capitanio U, Yuvaraja TB, Rawal S, Moon DA, Sivaraman A, Maes KK, Porpiglia F, Gautam G, Turkeri L, Bhandari M, Jeong W, Menon M, Rogers CG, Abdollah F. Omission of Cortical Renorrhaphy During Robotic Partial Nephrectomy: A Vattikuti Collective Quality Initiative Database Analysis. Urology. 2020 Dec;146:125-132. doi: 10.1016/j.urology.2020.09.003. Epub 2020 Sep 15. PMID 32941944
- BACKGROUNDAlrishan Alzouebi I, Williams A, Thiagarjan NR, Kumar M. Omitting Cortical Renorrhaphy in Robot-Assisted Partial Nephrectomy: Is it Safe? A Single Center Large Case Series. J Endourol. 2020 Aug;34(8):840-846. doi: 10.1089/end.2020.0121. PMID 32316759
- BACKGROUNDBahler CD, Dube HT, Flynn KJ, Garg S, Monn MF, Gutwein LG, Mellon MJ, Foster RS, Cheng L, Sandrasegaran MK, Sundaram CP. Feasibility of omitting cortical renorrhaphy during robot-assisted partial nephrectomy: a matched analysis. J Endourol. 2015 May;29(5):548-55. doi: 10.1089/end.2014.0763. Epub 2015 Mar 10. PMID 25616087
- BACKGROUNDKazama A, Attawettayanon W, Munoz-Lopez C, Rathi N, Lewis K, Maina E, Campbell RA, Lone Z, Boumitri M, Kaouk J, Haber GP, Haywood S, Almassi N, Weight C, Li J, Campbell SC. Parenchymal volume preservation during partial nephrectomy: improved methodology to assess impact and predictive factors. BJU Int. 2024 Aug;134(2):219-228. doi: 10.1111/bju.16300. Epub 2024 Feb 14. PMID 38355293
- BACKGROUNDHung AJ, Cai J, Simmons MN, Gill IS. "Trifecta" in partial nephrectomy. J Urol. 2013 Jan;189(1):36-42. doi: 10.1016/j.juro.2012.09.042. Epub 2012 Nov 16.