Evaluation of probiotic effect and placebo on reduction of surgical site infection after colectomy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201304187197N7

Enrollment

Registered

2013-05-12

Start date

2012-02-04

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer. C18.9 Colon, unspecified, C19 Malignant neoplasm of rectosigmoid junction, C20 Malignant neoplasm of rectum, C21.0 Anus, unspecified

Interventions

Intervention 1: Control group: Placebo was given every 12 hours/ orally from 4 days before through 10 days after operation. Intervention 2: Case group: Balance capsule made in England was given every

Treatment - Drugs

Control group: Placebo was given every 12 hours/ orally from 4 days before through 10 days after operation

Case group: Balance capsule made in England was given every 12 hours/ orally from 4 days before through 10 days after operation

Eligibility

Sex/Gender

All

Age

13 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients older than 13 years old with colorectal cancer that came to Razi, Emam Khomeini and Golestan hospital for colectomy between 1390-1391 Exclusion criteria: 1- critically ill patients 2- patients with central venous catheter 3- disrupted mucosal barrier 4- short bowel syndrome 5- abnormal cardiac valves 6- prosthetic valves 7- prosthetic joints

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Surgical site infection. Timepoint: beginning of intervention and first, second, third, tenth and thirtieth days after operation. Method of measurement: fever, respiratory rate, pulse rate, pulse rate, cellulitis, dyscharge.	—

Secondary

Measure	Time frame
WBC/diff. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: kit.;IL6. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: Bendermed kit.;TNF-a. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: Bendermed kit.;CRP. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: Roch kit.	—

Measure

Time frame

WBC/diff. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: kit.;IL6. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: Bendermed kit.;TNF-a. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: Bendermed kit.;CRP. Timepoint: beginning of investigation and 72 hours after surgery. Method of measurement: Roch kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDoctor Negin Honarvar

Ahwaz Jundishapur University of Medical Sciences

dr.nhonarvar@yahoo.com+98 61 1221 6840

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026