Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients with Diffuse Peritonitis

Universitas Padjadjaran

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Appendicitis with Perforation; Probiotic; Appendectomy

Treatments: Other: Placebo Group; Dietary Supplement: Lactobacillus plantarum sp Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06856434

SURG-202407.01

Details and patient eligibility

About

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?

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with diffuse peritonitis caused by appendicitis
• Patients undergoing laparotomic appendectomy.
• Patients aged 18 years or older.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Probiotic Group

Experimental group

Description:

Patient with perforated appendicitis who received an intervention

Treatment:

Dietary Supplement: Lactobacillus plantarum sp Probiotic

Placebo Group

Placebo Comparator group

Description:

Patients with perforated appendicitis who did not receive an intervention

Treatment:

Other: Placebo Group