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Abdominal/ Donor Site clinical trials

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NCT ID: NCT02076724 Active, not recruiting - Clinical trials for Abdominal Donor-site

Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap

Start date: March 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded. The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue. The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.

NCT ID: NCT01398982 Completed - Clinical trials for DIEP or Free MS-TRAM Breast Reconstruction

TAP Block in DIEP or Free MS-TRAM Donor Site: A RCT

Start date: July 2011
Phase: Phase 4
Study type: Interventional

Breast reconstruction using a patient's own abdominal tissue is one of the most common methods for restoring mastectomy defects for breast cancer patients. Despite its increasing popularity and safety, the abdomen remains a major source of postoperative pain. Adequate pain control is important as it has been shown to reduce medical complications, in-hospital death, shortens hospital stay, lessen chronic pain and disability, and in turn lower health-care costs. The current postoperative pain relief protocol consists primarily of a patient-controlled anesthesia device delivering intravenous opioids. Opioids can cause numerous side-effects such as sedation, headache, nausea, vomiting, breathing difficulties, bladder and bowel dysfunction. A promising approach to provide postoperative pain control of the abdominal incision is the newly developed transversus abdominis plane (TAP) peripheral nerve block. Although the TAP block has been found to be an effective pain-relief following major abdominal surgeries, its use has never been studied for breast reconstruction using abdominal tissue. Therefore, the investigators propose to rigorously study the efficacy of a TAP block in reducing postoperative abdominal pain following abdominal tissue breast reconstruction. This study has significant implications in improving both clinical care and health outcomes in patients undergoing this common method of breast reconstruction technique.