Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to compare two different techniques: endoscopic saphenous vein harvesting versus conventional open harvesting in patients undergoing coronary artery bypass grafting, either alone or in combination with another cardiac surgical procedure (valve surgery or arrhythmia surgery). The main questions the trial aims to answer are:
Does the endoscopic technique reduce surgical wound morbidity in terms of shorter hospital stays? Does endoscopic saphenous harvesting reduce the use of antibiotics for saphenectomy wound infections? Does the endoscopic technique reduce need for wound dressings due to necrosis and/or wound infection, and reduce need for analgesic treatment for wound pain? This prospective, randomized study will be conducted in the Cardiovascular Surgery Service at Hospital Clínico San Carlos.
Participants will be randomly assigned to a different saphenectomy technique. All patients will be assessed for saphenectomy wound complications upon discharge, and by phone call at 7 days, 1 month, and 3 months following the intervention.
Pain in the leg incisions will be assessed using a standarized pain scale.
Antibiotic and analgesic requirements for infection or pain in the saphenous vein surgical wound will be documeted.
The need for outpatient treatment or hospitalization due to surgical wounds will be evaluated.
A surgical wound cosmetic satisfaction survey will be administered to participants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic saphenectomy | Experimental | Endoscopic vein harvesting in CABG surgery requiring a vein graft with or without extracorporeal circulation |
|
| Conventional and open technique for saphenous vein harvesting | Active Comparator | Using the conventional open technique for harvesting the saphenous vein in any type of surgery with or without extracorporeal circulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvesting of the saphenous vein graft | Procedure | Most existing studies on endoscopic saphenectomy have been conducted in CABG with cardiopulmonary bypass (CBP), whereas most CABG surgeries at the study center are performed without CBP. The following outcomes will be identified:
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound morbidity | Days of hospital stay, use of antibiotics for saphenectomy wound infections, need for wound dressings due to necrosis and/or wound infection, and need for analgesic treatment for wound pain.
| From enrollment to the three-month follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from combined cardiac events | Freedom from death, myocardial infarction, and recurrent angina | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María B Solís Chávez, MD | Contact | +34613888798 | mabesolis95@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30417737 | Background | Zenati MA, Bhatt DL, Bakaeen FG, Stock EM, Biswas K, Gaziano JM, Kelly RF, Tseng EE, Bitondo J, Quin JA, Almassi GH, Haime M, Hattler B, DeMatt E, Scrymgeour A, Huang GD; REGROUP Trial Investigators. Randomized Trial of Endoscopic or Open Vein-Graft Harvesting for Coronary-Artery Bypass. N Engl J Med. 2019 Jan 10;380(2):132-141. doi: 10.1056/NEJMoa1812390. Epub 2018 Nov 11. | |
| 30165632 |
Not provided
Not provided
the IPD data will be share at the end of the study
Not provided
Not provided
Not provided
Not provided
Not provided
One group will receive the open technique for saphenous vein harvesting and the other group will receive the endoscopic technique.
Not provided
Not provided
Not provided
|
| Background |
| Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available. |
| 38929933 | Background | Sampath HK, Lee TJH, Cher CE, Liang S, Cheong OO, Kofidis T, Vitaly S, Sazzad F. A Comprehensive Clinical Outcome Analysis of Endoscopic Vessel Harvesting for Coronary Artery Bypass Surgery. J Clin Med. 2024 Jun 11;13(12):3405. doi: 10.3390/jcm13123405. |
| 31707009 | Background | Li G, Zhang Y, Wu Z, Liu Z, Zheng J. Mid-term and long-term outcomes of endoscopic versus open vein harvesting for coronary artery bypass: A systematic review and meta-analysis. Int J Surg. 2019 Dec;72:167-173. doi: 10.1016/j.ijsu.2019.11.003. Epub 2019 Nov 9. |
| 36054003 | Background | Kopjar T, Dashwood MR. Towards Endoscopic No-Touch Saphenous Vein Graft Harvesting in Coronary Bypass Surgery. Braz J Cardiovasc Surg. 2022 Sep 2;37(Spec 1):57-65. doi: 10.21470/1678-9741-2022-0144. |
| 30505742 | Background | Kodia K, Patel S, Weber MP, Luc JGY, Choi JH, Maynes EJ, Rizvi SA, Horan DP, Massey HT, Entwistle JW, Morris RJ, Tchantchaleishvili V. Graft patency after open versus endoscopic saphenous vein harvest in coronary artery bypass grafting surgery: a systematic review and meta-analysis. Ann Cardiothorac Surg. 2018 Sep;7(5):586-597. doi: 10.21037/acs.2018.07.05. |
| 35323908 | Background | Fudulu D, Angelini GD. Saphenous vein graft longevity: open or endoscopic, with VEST or without? Eur J Cardiothorac Surg. 2022 Jun 15;62(1):ezac144. doi: 10.1093/ejcts/ezac144. No abstract available. |
| 14722001 | Background | Allen KB, Heimansohn DA, Robison RJ, Schier JJ, Griffith GL, Fitzgerald EB. Influence of endoscopic versus traditional saphenectomy on event-free survival: five-year follow-up of a prospective randomized trial. Heart Surg Forum. 2003;6(6):E143-5. |