Comparative study of mechanical anastomotic coupling device versus hand sewn venous anastomosis: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Flap condition
Study Overview
Brief Summary
Microvascular anastomosis remains a technically difficult procedure and a critical determinant of the success of free tissue transfer (FTT). It dates back to 1900s and encompasses the transfer of autogenousvascularized tissue to reconstruct extensive tissue defects. A large variety of indications namely oncosurgical resection, trauma, aesthetics reconstruction making it imperative to incorporate a microvascular anastomosis for the purpose of reconstruction.
Free tissue transfer is a widely used procedure in reconstructive surgery. The most critical aspect of FTT is microvascular anastomosisand the key principle of this procedure is the microvascular anastomosis between the flap and recipient vessels.
Microsurgical anastomosis has traditionally been done using hand sewn techniques. Hand sewn microvascular anastomosis is the standard technique and is widely practiced by microsurgeons. This reconstruction is the apex of a reconstructive ladder in terms of complexity of the procedure.
However, due to extremely thin wall of veins, the hand sewn anastomosis is technically challenging and time consuming leading to surgeon’s fatigue. In literature, conventional hand sewn anastomosis (HS) has been reported to be associated with complications of anastomotic leak from patent anastomosis and thrombus formation. All of which culminate into flap failure and subsequent need for re-exploration. Since the first sutured microvascular anastomosis was described in 1902, microvascular anastomotic techniques have evolved considerably. Nakayama et al., gave the first description of venous coupling device in 19621, since then new venous coupling devices have been developed in order to simplify this complex procedure.
The recently introduced mechanical anastomotic coupling device (MACD) is helpful in venous anastomosis. It has gained popularity over the past decade withmany centers incorporating the same for venous anastomosis in free flap surgery2-5. The venous coupler has been designed to work on the principle of intima to intima contact without intraluminal suture material which might act as a site for thrombus promotion. In addition to this, it has been proposed that the use of MACD has significantly contributed to reducing the intraoperativetime, feasibility of anastomotic leak and thrombus formation. All of these directly alter surgeon’s fatigue & overall quality of surgery.
To the best of our knowledge randomized control trials on hand sewn (HS)versus MACD for microvascular anastomosis have not been published. Our study therefore aims to bridge this gap and also review the proposed benefits of MACD over HS anastomosis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 13.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Both genders will be selected for the study.
Exclusion Criteria
- •Recipient vessel size more than 4.0mm or less than 1.0mm.
- •Patients who have undergone radiation therapy prior to surgery.
Outcomes
Primary Outcomes
Flap condition
Time Frame: Whether the flap has failed or successful will be determined on 5th operative day.
Secondary Outcomes
- Rate of flap failures. Return to operation theatre due to venous thrombosis. Surgeon’s fatigue using Samn Perelli scale.(Flap monitoring every 2hours for first 24 hours then every 4th hour for next 2nd day and every 6th hour for 3rd, 4th and 5th day. Surgeon’s fatigue will be assessed at end of surgery.)
Investigators
Sanjay Maurya
Army Hospital Research and Referral
