RANDOMISED CONTROL TRIAL TO COMPARE THE EFFICACY OF SHIRA MICROCLAMPS AND ACLAND MICROCLAMPS IN MICROVASCULAR ANASTOMOSIS

STUDY DESIGN A single centre, parallel group, randomised control clinical trial on 30 patients requiring microvascular anastomosis. The selected patients were randomly divided into two groups: Group 1, n=15 (Control): Microvascular anastomosis using Acland microclamp. Group 2, n=15: Microvascular anastomosis using Shira microclamp. PARTICIPANTS AND SETTING The study was conducted in the Department of Plastic Surgery and Department of Maxillofacial Surgery, AIIMS Jodhpur. The randomisation was done using randomisation allocation software 2.0. The generated codes were sealed in sequentially numbered opaque envelopes. Informed consent was taken from all the participants of the study. The participants were recruited using the following inclusion and exclusion criteria: Inclusion criteria 1. All patients requiring microvascular anastomosis. 2. Patients willing to consent for the study. Exclusion criteria 1. Presence of active infection. 2. Patients unfit for surgery. 3. Patients requiring end to side anastomosis. Data Collection: 1. Assessment of patency of anastomosis by direct examination of the flap to evaluate the success rate. 2. Calculation of clamping time from clamping to de-clamping the vessel. 3. Calculation of anastomosis time from grasping the needle with the needle holder to cutting of the last suture. 4. Assessment of the need for clamp flipping. 5. Assessment of need of assistance using Shira clamp compared to Acland clamp. 6. Evaluation of ease of use.研究设计 本研究为一项单中心、平行组随机对照临床试验，共纳入30名需行微血管吻合术的患者。入组患者按随机方式分为两组： 组1（对照组，n=15）：采用Acland显微夹（Acland microclamp）行微血管吻合术。 组2（n=15）：采用Shira显微夹（Shira microclamp）行微血管吻合术。 研究对象与研究场景 本研究于印度全印度医学科学研究所焦特布尔分院（AIIMS Jodhpur）整形外科与颌面外科开展。随机分组采用随机分配软件2.0完成，生成的随机编码密封于编号依次排列的不透光信封内。本研究已获取所有受试者的知情同意。受试者招募遵循以下纳入与排除标准： 纳入标准 1. 所有需行微血管吻合术的患者。 2. 自愿签署本研究知情同意书的患者。 排除标准 1. 存在活动性感染。 2. 无法耐受手术的患者。 3. 需行端侧吻合术的患者。 数据采集 1. 通过直接观察皮瓣评估吻合口通畅性，以计算手术成功率。 2. 计算夹闭时长：从血管夹闭至松开夹闭的时间。 3. 计算吻合时长：从持针器夹持针具至剪断最后一根缝线的时间。 4. 评估是否需要翻转显微夹。 5. 相较于Acland显微夹，评估使用Shira显微夹时是否需要助手协助。 6. 评估器械使用便捷性。