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CTRI Number  CTRI/2024/08/072517 [Registered on: 14/08/2024] Trial Registered Prospectively
Last Modified On: 02/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study of coupling device verses hand-sewn venous anastomosis: a Randomized Controlled Trial 
Scientific Title of Study   Comparative study of mechanical anastomotic coupling device versus hand sewn venous anastomosis: A Randomised Controlled Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjay Maurya 
Designation  Professor and HOD 
Affiliation  Army Hospital Research and Referral 
Address  Department of Plastic Surgery Army Hospital Research and Referral Subroto Park Delhi Cantt New Delhi

New Delhi
DELHI
110010
India 
Phone  9622311177  
Fax    
Email  Drsanjaykmaurya@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saumya Gupta 
Designation  Senior Resident  
Affiliation  Army Hospital Research and Referral 
Address  Department of Plastic Surgery Army Hospital Research and Referral Subroto Park Delhi Cantt New Delhi

New Delhi
DELHI
110010
India 
Phone  9589657989  
Fax    
Email  Docsaumyagupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sanjay Maurya 
Designation  Professor and HOD 
Affiliation  Army Hospital Research and Referral 
Address  Department of Plastic Surgery Army Hospital Research and Referral Subroto Park Delhi Cantt New Delhi

New Delhi
DELHI
110010
India 
Phone  9622311177  
Fax    
Email  Drsanjaykmaurya@gmail.com  
 
Source of Monetary or Material Support  
Army Hospital Research and Referral, Subroto Park, Dhaula Kuan, New Delhi 110092 
 
Primary Sponsor  
Name  Army Hospital Research and Referral 
Address  Department of Plastic Surgery Army Hospital Research and Referral Subroto Park Delhi Cantt New Delhi 110010 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Maurya  Army Hospital Research and Referral  Department of Plastic Surgery Army Hospital Research and Referral Subroto Park Delhi Cantt
New Delhi
DELHI 
9622311177

Drsanjaykmaurya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Army Hospital Research and Referral  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  8-0 or 9-0 nylon sutures  Using standard hand sewn technique 
Intervention  MCAD by GEM Microvascular Anastomotic COUPLER Device and system, Synovis Micro Companies Alliance, Inc, USA  Synovis COUPLER Device and System, Synovis Micro Companies Alliance, Inc, USA tray including anastomotic device, measuring gauge, and coupler forceps will be used. 1.0-4.0mm couplers will be used for anastomosis. The couplers size will be determined with the vessel sizer by placing it close to the cut vein end. Under the magnification, lumens will be flushed with heparinized saline and minimal adventitial preparation will be done. Both donor and recipient veins will be marked at 0 &180 degrees respectively (3 and 9 o’clock) for appropriate alignment. Similar procedure is repeated with the recipient vein. The coupling device will be closed with an extra squeeze with a fine hemostat especially for larger veins to reduce the leak. Rings, with the completed anastomosis, will be then detached from the device. In cases where there is a discrepancy in the diameter of the vein a smaller size will be chosen matching the smaller diameter vein. In the event of venous thrombosis, the revision of venous anastomosis will be done by the HS technique. In case of thrombosis is due to artery the flap failure, return to theatre will not be included in the study & the same will be documented. 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Both genders will be selected for the study. 
 
ExclusionCriteria 
Details  Recipient vessel size more than 4.0mm or less than 1.0mm.
Patients who have undergone radiation therapy prior to surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Flap condition  Whether the flap has failed or successful will be determined on 5th operative day. 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
 
Target Sample Size
Modification(s)  
Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/06/2024 
Date of Study Completion (India) 30/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/12/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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 surgery2-5The 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.

 
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