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NCT06856434 | NOT YET RECRUITING | Appendicitis with Perforation

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

Padjadjaran University

Information provided by (Responsible Party):

Ricarhdo Valentino Hanafi, MD

Brief Summary:

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?

Condition or disease

Appendicitis with Perforation

Appendectomy

Probiotic

Intervention/treatment

Lactobacillus plantarum sp Probiotic

Placebo Group

Phase

EARLY_PHASE1

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-06-01
Estimated Study Completion Date : 2026-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients with Diffuse Peritonitis

Location Details

NCT06856434

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