Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial

NCT07190638 | Recruiting

• 1 other identifier: 87015525.0.1001.5128
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

RCC, Renal Cell Cancer

Keywords

Partial Nephrectomy; Robot-assisted; MEDULLARY SUTURE; MEDULLARY-ONLY SUTURE

Outcome Measures

Primary Outcomes (1)

• Estimated Blood loss

  Estimated blood loss, assessed to compare renorrhaphy techniques (single medullary suture vs. combined medullary and cortical suture) during partial nephrectomy. The volume, recorded in milliliters, was measured using a graduated collection canister connected to the assistant surgeon's suction device, with correction for the amount of saline solution instilled into the cavity.

  Perioperative/Periprocedural time

Secondary Outcomes (7)

• Change in estimated glomerular filtration rate (eGFR)

  1 day, 2 weeks, 2 months, and 5 months

• Percentage renal volume loss

  4 months

• Warm ischemia time

  Perioperative/Periprocedural time

• Participants with intraoperative or postoperative complications

  Through 5 months

• Console time

  Perioperative/Periprocedural time

Study Arms (2)

Medullary-only suturing (single-layer)

EXPERIMENTAL

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.

Procedure: Medullary-only suturing (single-layer); Device: Suture; Device: Hemostatic Agent

Medullary and cortical suturing (two-layer)

ACTIVE COMPARATOR

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.

Procedure: Medullary and cortical suturing (two-layer); Device: Suture; Device: Hemostatic Agent

Interventions

Medullary-only suturing (single-layer) PROCEDURE

Only the base layer (medulla) is sutured after tumor excision, Cortical suturing is omitted. Hemostatic agents are applied.

Also known as: Single-layer renorrhaphy

Medullary-only suturing (single-layer)

Suture DEVICE

Synthetic absorbable monofilament suture (Caproyl™ 3-0).

Medullary-only suturing (single-layer)

Medullary and cortical suturing (two-layer) PROCEDURE

Both medullary and cortical layers are sutured after tumor excision, Performed with robotic assistance using absorbable sutures. Hemostatic agents are applied

Also known as: double-layer renorrhaphy

Medullary and cortical suturing (two-layer)

Hemostatic Agent DEVICE

Hemostatic agents (e.g., Bleed Stp Plus, Surgicel® Fibrillar, Hemopatch®).

Medullary and cortical suturing (two-layer); Medullary-only suturing (single-layer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brazilian Institute of Robotic Surgery: lead

Study Sites (2)

Hospital MaterDei Salvador

Salvador, Estado de Bahia, 40220-005, Brazil

RECRUITING

Brazilian Institute of Robotic Surgery

Salvador, Estado de Bahia, 43017030, Brazil

RECRUITING

Related Publications (12)

• 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.

  PMID: 27960537 BACKGROUND

• 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.

  PMID: 32941944 BACKGROUND

• 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.

  PMID: 32316759 BACKGROUND

• 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.

  PMID: 25616087 BACKGROUND

• 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.

  PMID: 38355293 BACKGROUND

• 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.

  PMID: 23164381 BACKGROUND

• 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.

  PMID: 36980679 BACKGROUND

• 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.

  PMID: 39033764 BACKGROUND

• 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.

  PMID: 31792576 BACKGROUND

• Rose TL, Kim WY. Renal Cell Carcinoma: A Review. JAMA. 2024 Sep 24;332(12):1001-1010. doi: 10.1001/jama.2024.12848.

  PMID: 39196544 BACKGROUND

• 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.

  PMID: 36011051 BACKGROUND

• 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.

  PMID: 38572751 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sutures

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Nilo J Leão, MD.

  Brazilian Institute of Robotic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilo J Leão, MD.

CONTACT

+55 71 2626-3030; ibcrpesquisa@gmail.com

Felipe P Albuquerque, MD.

CONTACT

+55 71 99733-3330; fpinhoalbuquerque@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The blinding protocol will include the patient, the physician responsible for patient selection, the physician overseeing postoperative care, the professional conducting follow-up consultations, the students involved in collecting clinical follow-up data, and the team responsible for statistical analysis. However, the surgical team and the operating surgeon will not be blinded, nor will the students responsible for collecting intraoperative data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first group will undergo medullary-only suturing (single-layer) using 3-0 diameter synthetic absorbable monofilament poliglecaprone 25 suture (Caprofyl™), with early unclamping performed robotically. In the second group, both medullary and cortical suturing (two-layer) will be performed, using 3-0 Caprofyl™ for the medullary suture and, after early unclamping, 0-diameter braided synthetic absorbable polyglycolic suture (Vicryl™) for the cortical layer, also robotically assisted. 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.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: September 24, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)