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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Prospective, Randomized, Controlled Study to Assess the Effectiveness of Transcollation Technology to Reduce Bleeding in Lung Surgery

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.


Detailed Summary:

Study participation will start at signature of informed consent and each subject will be assessed preoperatively, within 4 weeks before surgery. A patient information leaflet will form the basis of discussions with the patient before written informed consent is obtained.

Patients will be evaluated intra-operatively, at 24 and 48 hours after surgery, and at discharge.

At the preoperative visit, the following information will be recorded on the patient's Case Report Form by a specialist Registrar:

  • Patient number
  • Patient initials
  • Date of visit
  • Demography (date of birth, sex, height, and weight)
  • Preoperative FEV1 and % predicted FEV1
  • Co-morbidities (chronic obstructive pulmonary disease [yes/no], current smoking habit [yes/no])
  • levels of hemoglobin (preoperative, postoperative, 24 h, 48 h and discharged)
  • perioperative complication.

Interventions

Patients undergoing Major Lung Surgery will be randomly assigned to one of two management strategies before the starting of the operation:

  1. Electrocautery Using routine instrument for hilar dissection, hemostasis and lisys of eventual pleural adhesions.
  2. Transcollation Technology Using Transcollation Technology for hilar dissection, hemostasis and lisys of eventual pleural adhesions.

Randomi
Sponsor: University of Roma La Sapienza

Current Primary Outcome: Blood Loss, Milliliters (mL) [ Time Frame: 24 hrs ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Blood loss (g/dl) [ Time Frame: 24 hrs ]

hemoglobin level in the blood compared to the pre-operative level


Original Secondary Outcome: Same as current

Information By: University of Roma La Sapienza

Dates:
Date Received: December 10, 2015
Date Started: March 2016
Date Completion: March 2017
Last Updated: December 12, 2015
Last Verified: December 2015