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BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a
Jiang-ming Chen1, Wei Geng2, Fu-bao Liu3
1Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, No. 678 Furong Road, Shushan District, , Anhui, Hefei, 230022, China. chenjm10@126.com.
Trials
|May 1, 2015
Summary
This study compares BiClamp forceps to clamp crushing for liver resection, aiming to reduce blood loss during surgery. Results will guide safer, more effective liver transection techniques.
Area of Science:
- Hepatobiliary Surgery
- Surgical Technology
- Minimally Invasive Procedures
Background:
- Significant blood loss during liver transection increases patient morbidity, mortality, and worsens prognosis.
- Existing surgical devices aim to minimize intraoperative blood loss during liver resections.
- Reducing blood loss is critical for improving outcomes in patients undergoing hepatectomy.
Purpose of the Study:
- To evaluate the safety and effectiveness of BiClamp forceps for liver parenchymal transection.
- To compare BiClamp forceps transection against a traditional clamp crushing technique.
- To determine the impact of different transection methods on intraoperative blood loss.
Main Methods:
- A prospective, single-center, randomized controlled trial involving adult patients undergoing hepatectomy with hepatic vascular exclusion.
- 48 patients per arm, randomized to either BiClamp forceps or clamp crushing technique.
- Primary endpoint: total intraoperative blood loss; secondary endpoints: complications and adverse events over three months.
Main Results:
- The study is designed to detect a difference of approximately 200 ml in blood loss between the two groups.
- Statistical analysis will be based on the intention-to-treat population.
- Patient outcomes will be assessed over a three-month follow-up period.
Conclusions:
- This trial will provide crucial data on the efficacy and safety of BiClamp forceps versus clamp crushing for liver resection.
- Findings will inform surgical practice regarding the optimal technique for parenchymal transection.
- The study aims to establish BiClamp forceps as a potentially superior method for reducing blood loss in liver surgery.
