Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial
NCT ID: NCT07190638
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-07-23
2027-05-31
Brief Summary
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Detailed Description
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The preservation of renal function has become a central concern in the surgical management of renal tumors, especially given the long-term consequences of chronic kidney disease on patient morbidity and mortality. Partial nephrectomy is preferred for localized renal masses as it allows for oncologic control while maintaining renal function. Traditionally, renorrhaphy involves a two-layer closure including both medullary and cortical sutures. However, recent literature suggests that omitting the cortical suture may reduce renal parenchymal volume loss and warm ischemia time, while possibly introducing a higher rate of minor complications.
Despite growing interest in minimally invasive nephron-sparing techniques, robust prospective and randomized trials directly comparing single-layer (medullary-only) and double-layer (cortical and medullary) renorrhaphy remain scarce. The single-layer technique, first proposed to address concerns over unnecessary cortical compression and ischemic injury, is gaining attention for its simplicity and potential advantages in reducing blood loss and operative time.
This trial aims to evaluate whether avoiding cortical suturing during robot-assisted partial nephrectomy leads to improved postoperative renal function, reduced blood loss, and shorter surgical duration. Patients will be randomly assigned to undergo either medullary-only renorrhaphy or the conventional dual-layer approach. Both techniques will be assessed for their effect on warm ischemia time, complication rates, renal volume loss, and surgical efficiency.
The study will enroll 80 patients undergoing partial nephrectomy for renal masses, distributed evenly across the two intervention groups. This sample size was calculated to ensure statistical power to detect differences in estimated blood loss, the primary outcome. A broad range of secondary outcomes will be measured at multiple postoperative time points, including estimated glomerular filtration rate, renal volume, incidence of surgical complications, and quality of life indicators.
By employing a randomized, prospective, and blinded design, the trial seeks to minimize bias and deliver high-quality evidence to guide future surgical decision-making. Ultimately, the study aims to clarify whether cortical renorrhaphy can be safely omitted without compromising patient outcomes, potentially simplifying surgical technique and improving recovery profiles in this patient population.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
If the surgeon deems it necessary to perform a second suture using Vicryl™ 0 in the first group after unclamping, it will be carried out, and the surgeon's reasoning will be documented. These patients will be analyzed separately in order to identify predictive factors for such a change.
Hemostatic agents will be used in all groups.
TREATMENT
DOUBLE
Study Groups
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Medullary-only suturing (single-layer)
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.
Medullary-only suturing (single-layer)
Only the base layer (medulla) is sutured after tumor excision, Cortical suturing is omitted. Hemostatic agents are applied.
Suture
Synthetic absorbable monofilament suture (Caproyl™ 3-0).
Hemostatic Agent
Hemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).
Medullary and cortical suturing (two-layer)
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.
Medullary and cortical suturing (two-layer)
Both medullary and cortical layers are sutured after tumor excision, Performed with robotic assistance using absorbable sutures. Hemostatic agents are applied
Suture
Synthetic absorbable monofilament suture (Caproyl™ 3-0), absorbable braided suture (Vicryl™ 0)
Hemostatic Agent
Hemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).
Interventions
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Medullary-only suturing (single-layer)
Only the base layer (medulla) is sutured after tumor excision, Cortical suturing is omitted. Hemostatic agents are applied.
Suture
Synthetic absorbable monofilament suture (Caproyl™ 3-0).
Medullary and cortical suturing (two-layer)
Both medullary and cortical layers are sutured after tumor excision, Performed with robotic assistance using absorbable sutures. Hemostatic agents are applied
Suture
Synthetic absorbable monofilament suture (Caproyl™ 3-0), absorbable braided suture (Vicryl™ 0)
Hemostatic Agent
Hemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Brazilian Institute of Robotic Surgery
OTHER
Responsible Party
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Principal Investigators
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Nilo J Leão, MD.
Role: PRINCIPAL_INVESTIGATOR
Brazilian Institute of Robotic Surgery
Locations
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Hospital MaterDei Salvador
Salvador, Estado de Bahia, Brazil
Brazilian Institute of Robotic Surgery
Salvador, Estado de Bahia, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Williams 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.
Arora 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.
Alrishan 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.
Bahler 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.
Kazama 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.
Hung 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.
Ruiz Guerrero E, Claro AVO, Ledo Cepero MJ, Soto Delgado M, Alvarez-Ossorio Fernandez JL. Robotic versus Laparoscopic Partial Nephrectomy in the New Era: Systematic Review. Cancers (Basel). 2023 Mar 16;15(6):1793. doi: 10.3390/cancers15061793.
Young M, Jackson-Spence F, Beltran L, Day E, Suarez C, Bex A, Powles T, Szabados B. Renal cell carcinoma. Lancet. 2024 Aug 3;404(10451):476-491. doi: 10.1016/S0140-6736(24)00917-6. Epub 2024 Jul 18.
Shatagopam K, Bahler CD, Sundaram CP. Renorrhaphy techniques and effect on renal function with robotic partial nephrectomy. World J Urol. 2020 May;38(5):1109-1112. doi: 10.1007/s00345-019-03033-w. Epub 2019 Dec 2.
Rose TL, Kim WY. Renal Cell Carcinoma: A Review. JAMA. 2024 Sep 24;332(12):1001-1010. doi: 10.1001/jama.2024.12848.
Makino T, Kadomoto S, Izumi K, Mizokami A. Epidemiology and Prevention of Renal Cell Carcinoma. Cancers (Basel). 2022 Aug 22;14(16):4059. doi: 10.3390/cancers14164059.
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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87015525.0.1001.5128
Identifier Type: -
Identifier Source: org_study_id
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