A Randomized controlled Trial Comparing the Postoperative Outcomes of the Chivate Procedure versus Stapled Hemorrhoidopexy in patients with Grade II and III Hemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the proportion of patients achieving complete cessation of hemorrhoidal symptoms — including bleeding, prolapse, pain during defecation, between the Chivate Procedure and Stapled Hemorrhoidopexy groups.
研究概览
简要总结
Though performed widely, Stapled Hemorrhoidopexy come under scrutiny due to its recurrence rates and costs, especially in resource-poor areas like India. The Chivate procedure is appealing as a low-cost option and technically feasible in health care system. There are some areas where good quality randomized controlled trials (RCTs) directly contrasting the two are lacking, especially in the Indian context [13]. With the growing case numbers now being reported in the Jammu region, a comparative investigation into the efficacy, postoperative outcomes, pain scoring, complications, and recurrence rate between the Chivate procedure and Stapled Hemorrhoidopexy are much needed. This data would prove to be critical for evidence-based decision-making and thus inform institutional and state-level policies and guidelines. The aim of this study is to fill the lacuna by evaluating postoperative outcomes using standardized measures to provide sound evidence to further improve clinical practice in proctologic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients between 18–60 years of age diagnosed with Grade II or III internal haemorrhoids included under ASA Grade I–II surgical risk category and willing to provide written informed consent are included in the study.
排除标准
- •Patient with External Haemorrhoids 2)Patients with history of previous anorectal surgery 3)Coexisting anal conditions (such as anal fissures or fistulas) 4)Pregnant women.
结局指标
主要结局
To assess the proportion of patients achieving complete cessation of hemorrhoidal symptoms — including bleeding, prolapse, pain during defecation, between the Chivate Procedure and Stapled Hemorrhoidopexy groups.
时间窗: To assess the proportion of patients achieving complete cessation of hemorrhoidal symptoms — including bleeding, prolapse, pain during defecation, anal discomfort postoperatively between the Chivate Procedure and Stapled Hemorrhoidopexy groups.
次要结局
- 1.To assess the length of hospital stay among patients undergoing the Chivate Procedure versus Stapled Hemorrhoidopexy for Grade II & III internal hemorrhoids at AIIMS Vijaypur.(1.To assess the length of hospital stay among patients undergoing the Chivate Procedure versus Stapled Hemorrhoidopexy for Grade II & III internal hemorrhoids at AIIMS Vijaypur.1.To assess the length of hospital stay among patients undergoing the Chivate Procedure versus Stapled Hemorrhoidopexy for Grade II & III internal hemorrhoids at AIIMS Vijaypur.)
研究者
Dr Aelan
All india institue of medical sciences Vijaypur, Jammu