| 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
|
|
|
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
|
|
|
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 surgery2-5. 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. |