Effect of Consumption of Lactobacillus Plantarum Sp Probiotics on Leukocyte Levels, Segment Neutrophil Type Counts, Post-operative Pain, and Length of Stay in Patients with Diffuse Peritonitis Due to the Perforated Appendix That Has Been Performed Laparotomy Appendectomy At Dr. Hasan Sadikin Hospital: a Randomized Controlled Trials
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- White Blood Cells Level
研究概览
简要总结
Does the administration of the probiotic Lactobacillus plantarum sp. have an impact on reducing leukocyte levels, segmented neutrophil counts, postoperative pain, and length of hospitalization in patients with diffuse peritonitis caused by perforated acute appendicitis who underwent laparotomy appendectomy at Dr. Hasan Sadikin Hospital?
详细描述
To determine whether the administration of the probiotic Lactobacillus plantarum sp. to patients with diffuse peritonitis caused by appendiceal perforation undergoing laparotomy appendectomy at Hasan Sadikin Hospital Bandung and Siloam Karawaci Hospital has a significant effect on leukocyte levels, segmented neutrophil counts, postoperative pain levels, and length of hospitalization compared to the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with diffuse peritonitis caused by appendicitis
- •Patients undergoing laparotomic appendectomy.
- •Patients aged 18 years or older.
排除标准
- •Patients with a history of previous laparotomy.
- •Patients who underwent laparotomy combined with surgery on other parts of the body.
- •Patients with a history of cancer.
- •Patients with pre-existing comorbidities (uncontrolled diabetes mellitus, congestive heart failure, end-stage renal disease [ESRD], human immunodeficiency virus [HIV], and systemic lupus erythematosus [SLE]).
- •Patients with multiple organ dysfunction syndrome (MODS).
- •Patients with prior consumption of probiotics.
研究组 & 干预措施
Probiotic Group
Patient with perforated appendicitis who received an intervention
干预措施: Lactobacillus plantarum sp Probiotic (Dietary Supplement)
Placebo Group
Patients with perforated appendicitis who did not receive an intervention
干预措施: Placebo Group (Other)
结局指标
主要结局
White Blood Cells Level
时间窗: From the day of randomization up to 5 days postoperatively
A white blood count measures the number of white blood cells (WBCs) in patients' blood.
次要结局
- Segmented Neutrophil level(From the day of randomization up to 5 days postoperatively)
- Post operative pain level(From the day of randomization up to 5 days postoperatively)
- Length of Hospital Stay(From the day of randomization up to 5 days postoperatively)
研究者
Ricarhdo Valentino Hanafi, MD
Principal Investigator
Universitas Padjadjaran