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

NCT02631889 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2015-12-16

No results posted yet for this study

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

Interventions

DEVICE

Transcollation technology

The use transcollation technology for dissection during lung surgery

DEVICE

Traditional electrocautery

The use of traditional Electrocautery for dissection during Lung Surgery

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Erino A Rendina, Professor · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631889 on ClinicalTrials.gov