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Comparative study of coupling device verses hand-sewn venous anastomosis: a Randomized Controlled Trial

Comparative study of mechanical anastomotic coupling device versus hand sewn venous anastomosis: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072517
Enrollment
64
Registered
2024-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: 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, US

Sponsors

Army Hospital Research and Referral
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Both genders will be selected for the study.

Exclusion criteria

Exclusion criteria: Recipient vessel size more than 4.0mm or less than 1.0mm. Patients who have undergone radiation therapy prior to surgery.

Design outcomes

Primary

MeasureTime frame
Flap conditionTimepoint: Whether the flap has failed or successful will be determined on 5th operative day.—

Secondary

MeasureTime frame
Rate of flap failures. Return to operation theatre due to venous thrombosis. Surgeonââ?¬â?¢s fatigue using Samn Perelli scale.Timepoint: 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. Surgeonââ?¬â?¢s fatigue will be assessed at end of surgery.—

Countries

India

Contacts

Public ContactSanjay Maurya

Army Hospital Research and Referral

Docsaumyagupta@gmail.com9589657989

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026