Clinical trial NCT06856434: Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients with Diffuse Peritonitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Appendicitis with Perforation
Appendectomy
Probiotic
Keywords: Perforated Appendicitis
Appendectomy
Probiotic
Laparotomy
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Eligibility 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.

Primary outcomes:
measure: White Blood Cells Level
timeFrame: From the day of randomization up to 5 days postoperatively
Secondary outcomes:
measure: Segmented Neutrophil level
timeFrame: From the day of randomization up to 5 days postoperatively
measure: Post operative pain level
timeFrame: From the day of randomization up to 5 days postoperatively
measure: Length of Hospital Stay
timeFrame: From the day of randomization up to 5 days postoperatively
Other outcomes:
Locations:
Study officials:
References:
citation: Guan L, Liu Z, Pan G, Zhang B, Wu Y, Gan T, Ouyang G. The global, regional, and national burden of appendicitis in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. BMC Gastroenterol. 2023 Feb 22;23(1):44. doi: 10.1186/s12876-023-02678-7.