跳至主要内容
临床试验/NCT03742583
NCT03742583已完成不适用

Evaluating the Burst Pressure of Simulated Bowel Anastomosis Constructed Using the Reverse Half-Hitch Alternating Post Knots

Queen's University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Burst pressure (mm Hg) of repaired enterotomies

研究概览

简要总结

Square knots are the gold standard for hand-tied surgical knots; however, they are difficult to reproduce in deep body cavities and can inadvertently result in slipped knots. The investigators have shown in previous work that the reversing half-hitch alternating post (RHAP) surgical knot is a non-inferior alternative to the square surgical knot based on its tensile strength and performance in limited working spaces. Prior to introducing RHAP knot in routine surgical practice, it is important to objectively demonstrate similar physical characteristics of anastomosis created using RHAP and standard square knots. This study aims to compare the burst pressure of cadaveric porcine small bowel anastomosis constructed using RHAP and standard square knots on a flat surface and in a simulated deep body cavity.

The investigators are conducting a prospective randomized controlled study of novice medical students allocated to proficiency-based training in RHAP and square surgical knots. Knot tying proficiency will be assessed using a knot-tying checklist. Number of repetitions and time required to achieve proficiency will be tracked for each group. Once proficiency has been achieved by participants in RHAP and square knots group, each participant will perform two-hand sewn small bowel anastomosis using cadaveric porcine small bowel. One anastomosis will be performed on a flat surface and the other will be formed in a simulated deep body cavity. Burst pressure of the anastomoses will be tested using a column of water, and results will be compared between groups. Simple descriptive statistics will be performed for both groups. Between group comparisons of knot-tying proficiency and burst pressure will be performed using t-test. Learning curves within each group will be analyzed using paired 1-way ANOVA. SPSS Statistics (v. 21, IBM, New York, USA) will be used for all statistical analysis, with significance set to p<0.05.

The investigators hypothesize that burst pressure of cadaveric porcine small bowel anastomosis will be equivalent for anastomosis constructed using RHAP and standard square knots.

The results of this study will provide further validity evidence in support of RHAP as suitable alternative to the square surgical knots.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Undergraduate first or second year medical/non-medical student

排除标准

  • Third year or greater undergraduate medical student

研究组 & 干预措施

Square Knot

Active Comparator

干预措施: Square Knot (Other)

Reversing Half-Hitch Alternating Post Knot

Active Comparator

干预措施: RHAP Knot (Other)

结局指标

主要结局

Burst pressure (mm Hg) of repaired enterotomies

时间窗: One session ~2-4 hours

Once the enterotomy in the porcine small bowel has been repaired by participants with knots according to the randomized intervention arm, blinded evaluators will tie off one end of the bowel and fill the other end with normal saline. Pressure will be applied the bag of normal saline and the pressure at which the repaired enterotomy leaks will be recorded. The pressure will be recorded in mm Hg.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Boris Zevin

Investigator

Queen's University

研究点 (2)

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