Study to Assess the Effectiveness of Transcollation Technology to Reduce Bleeding in Lung Surgery

NCT02631889 | Unknown

• 1 other identifier: V1/2015
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

Major lung resection is one of the most common procedures performed in thoracic surgery, but it may involve considerable bleeding and the occasional need for a transfusion and/or reoperation for bleeding in specific cases. In addition, lysis of pleural-parenchymal adhesions and dissection can represent a challenge in patients who have undergone chemotherapy and/or radiation therapy, and in patients with bronchiectasis or COPD. Several intraoperative methods have been used to manage blood loss, including topical haemostatic agents, bipolar sealers or electrocautery. Transcollation technology (TT) consists of a disposable bipolar sealer that uses a radiofrequency coagulation system to deliver a saline solution that provides haemostatic sealing of soft tissue and bone and provides localized cooling without charring. Blood loss reduction has been previously described in several fields of surgery. The primary end-point of the proposed trial is to assess if the ability of Transcollation Technology in reducing the proportion of patients showing bleeding perioperatively within the setting of a prospective randomized controlled trial. The secondary end-point is to assess if Transcollation Technology is able to improve postoperative outcomes reducing the length of hospital stay.

Conditions

Blood Loss, Surgical

Outcome Measures

Primary Outcomes (1)

• Blood Loss, Milliliters (mL)

  The mean quantity of chest drain fluids at 24 hours of patients in the Transcollation technology (TT) group compared with electrocautery group.

  24 hrs

Secondary Outcomes (1)

• Blood loss (g/dl)

  24 hrs

Other Outcomes (1)

• Length of hospital stay

  7 days

Study Arms (2)

Transcollation technology

EXPERIMENTAL

the use of transcollation technology for hilium dissection during Lung surgery

Device: Transcollation technology

Traditional Electrocautery

ACTIVE COMPARATOR

The use of electrocautery for hilium dissection during lung surgery

Device: Traditional electrocautery

Interventions

Transcollation technology DEVICE

The use transcollation technology for dissection during lung surgery

Transcollation technology

Traditional electrocautery DEVICE

The use of traditional Electrocautery for dissection during Lung Surgery

Traditional Electrocautery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be considered for enrollment, patients must:
• be aged ≥ 18 years (of either gender)
• have provided written informed consent prior to participation in the study
• undergoing to major lung surgery with an open approach.

You may not qualify if:

• To be considered for enrollment, patients must not:
• rethoracotomy
• presence of pleural adhesions
• coagulitive disorders or disease
• have a known immune system disorder or immunodeficiency
• be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue \[lung or parts of lymph nodes\] for biological research may occur in the same patients)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (4)

• S Hammond J, Muirhead W, Zaitoun AM, Cameron IC, Lobo DN. Comparison of liver parenchymal ablation and tissue necrosis in a cadaveric bovine model using the Harmonic Scalpel, the LigaSure, the Cavitron Ultrasonic Surgical Aspirator and the Aquamantys devices. HPB (Oxford). 2012 Dec;14(12):828-32. doi: 10.1111/j.1477-2574.2012.00547.x. Epub 2012 Aug 26.

  PMID: 23134184 BACKGROUND

• Uchiyama A, Miyoshi K, Nakamura K. VIO soft-coagulation system for major pulmonary resections: results in 68 patients with primary lung cancer. Gen Thorac Cardiovasc Surg. 2011 Mar;59(3):175-8. doi: 10.1007/s11748-010-0709-5. Epub 2011 Mar 30.

  PMID: 21448793 BACKGROUND

• Litle VR, Swanson SJ. Postoperative bleeding: coagulopathy, bleeding, hemothorax. Thorac Surg Clin. 2006 Aug;16(3):203-7, v. doi: 10.1016/j.thorsurg.2006.05.010.

  PMID: 17004547 BACKGROUND

• Falez F, Meo A, Panegrossi G, Favetti F, La Cava F, Casella F. Blood loss reduction in cementless total hip replacement with fibrin spray or bipolar sealer: a randomised controlled trial on ninety five patients. Int Orthop. 2013 Jul;37(7):1213-7. doi: 10.1007/s00264-013-1903-8. Epub 2013 May 18.

  PMID: 23685830 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Erino A Rendina, Professor

  University of Roma La Sapienza

  STUDY CHAIR

Central Study Contacts

mohsen ibrahim, Profssor

CONTACT

+393487325912; mohsen.ibrahim@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 16, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 16, 2015

Record last verified: 2015-12