Effect of Low-Pressure Pneumoperitoneum versus Standard Pressure on Post-operative discomfort and changes in various Inflammatory markers in Laparoscopic Cholecystectomy: A Randomized Control Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. To determine if there is a significant difference in pain levels, as measured by the Visual Analogue Score (VAS), at four pre determined time points: 6hours, 12 hours, 24 hours, and 7 days post-operation among patients undergoing laparoscopic cholecystectomy with low-
研究概览
简要总结
TITLE:Effect of low pressure pneumoperitoneum on postoperative discomfort and changes in various inflammatory markers in laparoscopic cholecystectomy :a randomized controlled trial
OBJECTIVE:
PRIMARY OBJECTIVE-To analyse the significant difference in pain using the visual analogue score at four set point (6 hr,12hr,24hr,7 days post op) & to observe a significant change in the collected in the collected inflammatory markers from baseline.
secondary objectives:To assess the requirement of analgesia, duration of surgery ,difficulty observed by the surgeon, the need for putting a drain ,and the overall duration of stay in the hospital following the surgery.
METHODOLOGY AND STUDY DESIGN :This study is randomised, single -blinded control trial involving 100 patients admitted to the surgery department of all India institute of medical sciences ,Gorakhpur .,over 2 yr duration.Patients meeting the inclusion- exclusion criteria will be randomized into two groups:GROUP A(interventional group ):Scheduled for laparoscopic cholecystectomy at low-pressure(8-10 mm hg ).Group B(control group ):Scheduled for laparoscopic cholecystectomy at standard -pressure (12-14 mm hg).
INCLUSION CRITERIA :Participants aged 18yr to 60 yr regardless of gender ,with a low anesthetic risk score of 1 or 2 according to the American Society of Anaesthesiologists (ASA),and having mild to moderate cholecystitis and simple symptomatic gallbladder stone disease as confirmed by ultrasonography.
EXCLUSION CRITERIA:Patient with gall bladder malignancy ,acute cholecystitis ,ERCP with and without a stent in place among other specific condition .
EXPECTED OUTCOME :The study aims to establish whether low-pressure pneumoperitoneum can be a new standard of care for laparoscopic cholecystectomy in patient with mild to moderate gallstone disease .It is expected to evaluate the efficacy and safety to low-pressure pneumoperitoneum in reducing postoperative pain and inflammation ,potentially leading to recommendations for changes in surgical practice to improve patient outcomes.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Any age ranges from 18 to 60 years old.
- •Both sex included with Low Anesthetic Risk Score of 1 or 2 according to the American Society of Anesthesiologists (ASA).
- •Mild to moderate cholecystitis and simple symptomatic gallbladder stone disease, as confirmed by USG.
排除标准
- •Gall bladder malignancy.
- •Acute cholecystitis.
- •Choledocholithiasis.
- •H/O ERCP with and without a stent in place.
- •Other causes of shoulder pain such subacromial bursitis, rheumatoid arthritis, tendinitis, and other musculoskeletal conditions; coronary artery diseases; COPD; asthma; history of cancer; jaundice; or any other co-morbidity.
- •Who had previous upper abdomen surgery.
- •BMIs below 18.5 or above 29.
- •ASA grades III, IV, or ,V.
- •Cognitive impairment, long-term painkiller use, or a history of alcohol addiction.
- •People who have been found with acute cholecystitis by ultrasonography or who have had it in the past.
结局指标
主要结局
1. To determine if there is a significant difference in pain levels, as measured by the Visual Analogue Score (VAS), at four pre determined time points: 6hours, 12 hours, 24 hours, and 7 days post-operation among patients undergoing laparoscopic cholecystectomy with low-
时间窗: 6hours, 12 hours, 24 hours, and 7 days Post-Laparoscopic Cholecystectomy
pressure pneumoperitoneum compared to standard pressure.
时间窗: 6hours, 12 hours, 24 hours, and 7 days Post-Laparoscopic Cholecystectomy
2.To evaluate significant changes in inflammatory markers from baseline values in the same patient population.
时间窗: 6hours, 12 hours, 24 hours, and 7 days Post-Laparoscopic Cholecystectomy
次要结局
- To assess and compare theneed for additional pain medicationpost-operationbetween the low-pressure and standard-pressure pneumoperitoneum groups.(To record and compare the length of time the surgery takes under low-pressure versus standard-pressure pneumoperitoneum.)
研究者
SWATI PRASAD
All India Institute of Medical Science Gorakhpur.