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临床试验/NCT07601594
NCT07601594已完成不适用

Early Ileostomy Reversal at Two Months Versus Three Months: A Randomized Controlled Trial

Gulab Devi Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1

研究概览

简要总结

This randomized controlled trial compares early (8 weeks) versus standard (12 weeks) ileostomy reversal in patients with confirmed anastomotic healing, evaluating postoperative complications and recovery outcomes.

详细描述

This open-label randomized controlled trial was conducted at Gulab Devi Teaching Hospital, Lahore, Pakistan, between August 2025 and January 2026 to compare early versus standard timing of ileostomy reversal. Patients aged 14 to 55 years with a protective loop ileostomy following colorectal surgery and radiologically confirmed anastomotic healing were enrolled. Participants were randomized in a 1:1 ratio to undergo ileostomy reversal at approximately 8 weeks (early group) or 12 weeks (standard group).

The primary outcome was the rate of postoperative complications occurring during the index hospital admission following ileostomy reversal. Secondary outcomes included length of hospital stay, time to first oral intake, time to return to normal activities, patient-reported comfort using a visual analogue scale, and 30-day readmission rates.

All procedures were performed using a standardized surgical technique by experienced surgeons within the same unit. Statistical analysis was performed using appropriate tests for continuous and categorical variables, with a significance threshold of p<0.05.

The study aimed to evaluate whether earlier ileostomy reversal is safe and associated with improved recovery outcomes in a resource-limited tertiary care setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • - Age 14-55 years Protective loop ileostomy Radiologically confirmed anastomotic healing

排除标准

  • Colorectal malignancy Abdominal tuberculosis Total colectomy Unfit for anesthesia

研究者

发起方
Gulab Devi Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hamza Akhtar

Principal Investigator

Gulab Devi Hospital

研究点 (1)

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