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临床试验/NCT07713433
NCT07713433招募中不适用

Comparison of Outcomes of Pre-operative Oral Antibiotics vs no Antibiotics in Elective Colorectal Surgeries in Children

Muhammad Zubair Shoukat1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
74
试验地点
1
主要终点
Incidence of Anastomotic Leak

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Children with small bowel stomas
  • poor general condition (Malnutrition, immunodeficiency)
  • Previous attempt at repair of colostomy (Reversal/Pull through)

结局指标

主要结局

Incidence of Anastomotic Leak

时间窗: 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

Incidence of Surgical Site Infection

时间窗: 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)

次要结局

  • Length of Hospital Stay(From per-operative day till 30 days post-Operatively)
  • Grade of Surgical Site Infection(from 1st day of surgery till 3 weeks post operatively)

研究者

发起方
Muhammad Zubair Shoukat
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Zubair Shoukat

Assistant Professor

University of Child Health Sciences and Children's Hospital, Lahore

研究点 (1)

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