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临床试验/CTRI/2024/10/075571
CTRI/2024/10/075571尚未招募4 期

Comparative efficacy of body first versus conventional techniques in achieving critical view of safety in laparoscopic cholecystectomy a single blinded block randomized controlled trial

Dr Jagani Harsha Sai1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1.Rate and quality of achievement of the Critical View of Safety which will be defined according to Strasberg criteria of doublet photography

研究概览

简要总结

Gall stone disease is a major health problem affecting people all around the world. Evidences suggests that prevalence of gall stone diseases are on the rise. Gold standard treatment for symptomatic gall stone diseases is laparoscopic cholecystectomy. Critical view of safety is measured as a end point of Hepatocystic triangle dissection, which can be achieved by different methods of dissection. The present prospective randomized trial was undertaken to compare the efficacy of achievement of the Critical View of Safety and to analyse the operative time required for each technique.

The study will be conducted at the Department of General Surgery, All India Institute of Medical Sciences, Gorakhpur Uttar Pradesh India. This tertiary care centre is equipped with advanced medical facilities and a high volume of surgical cases, providing a suitable environment for conducting a randomized controlled trial. The setting ensures access to a diverse patient population undergoing elective Laparoscopic cholecystectomy, allowing for robust data collection and analysis. This study is a prospective, randomized, controlled, single-blinded, parallel assignment, single centre trial designed to compare the efficacy and safety of the body-first technique versus the conventional technique in achieving a critical view of safety during Laparoscopic cholecystectomy . A patient who will fulfill the inclusion criteria and does not satisfy any of the exclusion criteria will be randomized in to body first or conventional approach. The institution’s experienced surgical teams and state-of-the-art surgical suites will support the accurate assessment of both surgical techniques under study . CONSORT guidelines for randomized controlled trials will be followed. Outcome measures include the successful achievement of the Critical View of Safety which will be defined according to Strasberg criteria of doublet photography and Comparison of duration of surgery ,intraoperative and postoperative complications, recovery of gastrointestinal function , post-operative pain, nausea and vomiting, length of hospital stay, pre and post op change in inflammatory marker, patient satisfaction  between the two techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients scheduled for elective Laparoscopic cholecystectomy
  • Patients diagnosed with symptomatic gallbladder stone diseases based on clinical evaluation and imaging studies 3.Patients who provide informed consent to participate in the study.

排除标准

  • Patients requiring urgent or emergency surgery due to acute cholecystitis will be excluded from the study as they may have different surgical considerations and outcomes 2.Patients with a history of previous upper abdominal surgery that may significantly alter the surgical anatomy such as gastric bypass or liver resection
  • Patients with known or suspected biliary tract anomalies (e.g Mirizzi syndrome, anomalous biliary anatomy) or ductal pathology (e.g choledocholithiasis, strictures) identified preoperatively
  • Patients with contraindications to laparoscopic surgery such as severe cardiopulmonary disease, uncontrolled coagulopathy, or intra-abdominal adhesions precluding safe laparoscopic access
  • Pregnant females will be excluded due to potential risks to maternal and fetal health and limitations in imaging modalities
  • Patients underwent administration of immunosuppressive agents in the past month
  • Patients with cognitive impairment or inability to provide informed consent.

结局指标

主要结局

1.Rate and quality of achievement of the Critical View of Safety which will be defined according to Strasberg criteria of doublet photography

时间窗: Primary outcome will be assessed intraoperatively and post operatively after completion of surgery

2.Duration of surgery

时间窗: Primary outcome will be assessed intraoperatively and post operatively after completion of surgery

次要结局

  • 1.Comparison of intraoperative and postoperative complications(2.Recovery of gastrointestinal function (passing of first flatus))

研究者

发起方
Dr Jagani Harsha Sai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Jagani Harsha Sai

All India Institute of Medical Sciences Gorakhpur

研究点 (1)

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