Gips Procedure Versus Karydakis Procedure for Pilonidal Sinus Disease: A Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Primary outcome: Time to complete wound healing
研究概览
简要总结
This is a prospective randomized controlled trial designed to compare the outcomes of surgical techniques for pilonidal sinus disease: The Gips Procedure and The Karydakis procedure. A total of 86 patients meeting eligibility criteria will be randomly allocated in equal numbers to either groups using block randomization with sealed opaque envelopes. The primary outcome is postoperative wound infection as per CDC criteria. Secondary outcomes include postoperative pain using VAS score, time to complete wound healing, duration of hospital stay, recurrence rate, and cosmetic outcome using POSAS Score. This study aims to determine whether the minimally invasive Gips procedure provides outcomes comparable or superior to the Karydakis flap while mininmizing morbidity. This is in phase III, single center parallel group RCT design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Elective Surgical candidates diagnosed with primary pilonidal sinus disease as per ICD-11
- •Patients consenting to be a part of the study.
排除标准
- •Acute Pilonidal abscess
- •Recurrent Pilonidal sinus disease
- •Branching sinus tracts
- •Pregnant female.
结局指标
主要结局
Primary outcome: Time to complete wound healing
时间窗: Time to complete wound healing ( measured from the day of surgery to the day of complete epithelialization) assessed at each postoperative visit on day 7th,14th, and one month
次要结局
- 1. wound infection rate as per CDC criteria.(2. postoperative pain using VAS scale)
研究者
Dr Sayed Saqib Hussain Shah
All India Institute of Medical Sciences(AIIMS), VIJAYPUR