- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07713433
Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery (PEACO)
Comparison of Outcomes of Pre-operative Oral Antibiotics vs no Antibiotics in Elective Colorectal Surgeries in Children
This study aims to evaluate whether giving oral antibiotics before elective colorectal surgery can improve recovery and reduce complications in children.
Colorectal surgery is commonly performed in children for conditions such as Hirschsprung disease, anorectal malformations, and other bowel disorders. Because the large intestine normally contains many bacteria, these operations carry a higher risk of infection and other postoperative complications. Some surgeons prescribe oral antibiotics before surgery to reduce the number of bacteria in the bowel, while others do not use this approach routinely.
In this study, children scheduled for elective colorectal surgery will be randomly assigned to one of two groups. One group will receive oral antibiotics before surgery, while the other group will receive standard preparation without oral antibiotics. All children will otherwise receive the same surgical and postoperative care according to hospital guidelines.
Researchers will compare the two groups for important outcomes including surgical site infection, leakage from the bowel connection (anastomotic leak), and length of hospital stay. Additional information regarding recovery and postoperative complications will also be collected.
Participation in the study will not affect the quality of treatment provided. Parents or guardians may withdraw their child from the study at any time without affecting routine medical care. The results of this research may help determine whether preoperative oral antibiotics should be routinely used in children undergoing elective colorectal surgery and may contribute to improving surgical outcomes and reducing healthcare costs.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Elective colorectal surgery in children is commonly performed for congenital and acquired conditions including Hirschsprung disease, anorectal malformations, stoma reversal procedures, inflammatory bowel disease, and selected colorectal pathologies. Compared with other abdominal operations, colorectal procedures are associated with a higher incidence of postoperative complications, particularly surgical site infections (SSI) and anastomotic leakage, owing to the high bacterial burden of the colon.
Various bowel preparation strategies have been employed to reduce bacterial contamination before colorectal surgery, including no bowel preparation, mechanical bowel preparation (MBP), oral antibiotic bowel preparation (OAB), and combinations of mechanical bowel preparation with oral antibiotics. Although several adult studies have suggested a reduction in postoperative infectious complications with oral antibiotic regimens, evidence in pediatric colorectal surgery remains limited and inconsistent. Consequently, significant variation exists among surgeons regarding the routine use of preoperative oral antibiotics.
This study aims to compare outcomes of preoperative oral antibiotic administration versus no oral antibiotics in children undergoing elective colorectal surgery. The primary objective is to determine whether preoperative oral antibiotics reduce postoperative complications, particularly surgical site infection and anastomotic leakage, and improve recovery as reflected by hospital stay.
This prospective randomized controlled trial will be conducted in the Department of Pediatric Surgery at the University of Child Health Sciences and The Children's Hospital Lahore. A total of 74 patients meeting the eligibility criteria will be enrolled and randomized in a 1:1 ratio into two groups using a lottery-based randomization method. Thirty-seven participants will be allocated to the intervention group and thirty-seven to the control group.
Participants in the intervention arm will receive a standardized regimen of preoperative oral antibiotics one day before surgery. The protocol utilizes oral ciprofloxacin and metronidazole as bowel decontamination agents. Participants in the control arm will undergo standard preoperative preparation without oral antibiotic administration. All other perioperative and postoperative management will follow departmental standard operating procedures and institutional guidelines.
Patients will be monitored for postoperative outcomes including surgical site infection, anastomotic leakage, and duration of hospital stay. Additional demographic, clinical, and operative variables will be recorded to assess potential confounding factors. Follow-up assessments will be conducted according to institutional postoperative protocols to identify early complications and recovery outcomes.
The primary outcomes of the study are:
- Surgical site infection (SSI).
- Anastomotic leakage.
- Postoperative hospital stay.
Secondary outcomes include overall postoperative morbidity and recovery parameters following elective colorectal surgery.
Data analysis will be performed using SPSS software. Continuous variables such as age and hospital stay will be summarized using means and standard deviations and compared using Student's t-test. Categorical variables, including diagnosis, surgical site infection, and anastomotic leakage, will be presented as frequencies and percentages and compared using Chi-square testing. Stratified analyses will be performed for relevant demographic and clinical variables. Statistical significance will be defined as a p-value of ≤0.05.
This study is expected to provide locally generated evidence regarding the effectiveness of preoperative oral antibiotic bowel preparation in pediatric colorectal surgery. The findings may help establish evidence-based perioperative protocols, reduce infectious complications, shorten hospitalization, and improve overall surgical outcomes in children undergoing elective colorectal procedures.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Muhammad Zubair Shoukat, MBBS, FCPS Pediatric Surgery
- Telefonnummer: 03126446646
- E-Mail: zubairshaukat@outlook.com
Studieren Sie die Kontaktsicherung
- Name: Mudassar Naveed, MBBS
- Telefonnummer: +923214977599
- E-Mail: mudassarnaveed81@gmail.com
Studienorte
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54300
- Rekrutierung
- University of Child Health Sciences, The Children's Hospital, Lahore
-
Kontakt:
- Mudassar Naveed, MBBS
- Telefonnummer: +923214977599
- E-Mail: mudassarnaveed81@gmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Children with colostomy planned for colostomy closure or pull through procedure for conditions including
- Anorectal malformation
- Hirschsprung's Disease
- Perianal Infections
- Perineal Trauma
- Any other condition requiring diversion colostomy
Exclusion Criteria:
- Children with small bowel stomas
- poor general condition (Malnutrition, immunodeficiency)
- Previous attempt at repair of colostomy (Reversal/Pull through)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Oral Antibiotics in ARM
Patients of anorectal malformation in this group will receive 3-day mechanical gut preparation along with oral antibiotics including ciprofloxacin and metronidazole one day before surgery
|
Patients in this group will receive preoperative mechanical bowel preparation for 3 days and oral antibiotics including Metronidazole and Ciprofloxacin one day before surgery
|
|
Aktiver Komparator: No Oral Antibiotics in ARM
Patients of anorectal malformation in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery
|
Patients in this group will receive only mechanical bowel preparation for 3 days before surgery and no oral antibiotics will be given in these patients before surgery
|
|
Experimental: Oral Antibiotics in Hirschprung's Disease
Patients of Hirschsprung's disease with colostomy in this group will receive 3-day mechanical gut preparation along with oral antibiotics including ciprofloxacin and metronidazole one day before surgery
|
Patients in this group will receive preoperative mechanical bowel preparation for 3 days and oral antibiotics including Metronidazole and Ciprofloxacin one day before surgery
|
|
Aktiver Komparator: No Oral Antibiotics in Hirschsprung's Disease
Patients of Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be given before surgery
|
Patients in this group will receive only mechanical bowel preparation for 3 days before surgery and no oral antibiotics will be given in these patients before surgery
|
|
Experimental: Oral Antibiotics in Others
Patients with colostomy for conditions other than anorectal malformation or HD, undergoing colostomy closure in this group will receive 3-day mechanical gut preparation along with oral antibiotics including ciprofloxacin and metronidazole one day before surgery
|
Patients in this group will receive preoperative mechanical bowel preparation for 3 days and oral antibiotics including Metronidazole and Ciprofloxacin one day before surgery
|
|
Aktiver Komparator: No Oral Antibiotics in Others
Patients with colostomy for conditions other than anorectal malformation or Hirschsprung's disease in this group will receive 3-day mechanical gut preparation and no oral antibiotics will be administered before surgery
|
Patients in this group will receive only mechanical bowel preparation for 3 days before surgery and no oral antibiotics will be given in these patients before surgery
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Anastomotic Leak
Zeitfenster: Within three weeks of surgery
|
It is defined as the disruption of anastomotic site, suspected on clinical examination and confirmed with radiological and operative findings and will be recorded as number of participants with anastomotic leak
|
Within three weeks of surgery
|
|
Incidence of Surgical Site Infection
Zeitfenster: From day of surgery till 3 weeks post operatively
|
Surgical site infection will be recorded using Southampton wound grading system and will be presented as number of participants with occurrence of surgical site infection (SSI)
|
From day of surgery till 3 weeks post operatively
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Length of Hospital Stay
Zeitfenster: From per-operative day till 30 days post-Operatively
|
It will be measured as time from surgery till discharge in number of days and will be presented as mean and standard deviation.
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From per-operative day till 30 days post-Operatively
|
|
Grade of Surgical Site Infection
Zeitfenster: from 1st day of surgery till 3 weeks post operatively
|
It will be recorded according to Southampton Grading Scale for SSI (Surgical site Infection) ranging from minimum grade of 0 to maximum grade of 5 where higher grade means more severe infection.
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from 1st day of surgery till 3 weeks post operatively
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Mudassar Naveed, MBBS, University of Child Health sciences & The Children's Hospital, Lahore
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Angeborene Anomalien
- Anomalien des Verdauungssystems
- Angeborene, erbliche und neonatale Krankheiten und Anomalien
- Anorektale Fehlbildungen
- Antiinfektiva
- Pharmakologische Maßnahmen
- Chemische Handlungen und Verwendung
- Therapeutische Anwendungen
- Antibakterielle Mittel
Andere Studien-ID-Nummern
- 952/CH-UCHS
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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