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临床试验/NCT00941941
NCT00941941Unknown不适用

Comparison of Non-mesh (Desarda) and Mesh (Lichtenstein) Methods for Inguinal Hernia Repair at Mulago Hospital: a Double-blind Randomised Controlled Trial

Makerere University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
98
试验地点
1
主要终点
Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)

研究概览

简要总结

The study aims at establishing the effectiveness of the non-mesh (Desarda) technique for the treatment of primary inguinal hernias at Mulago Hospital in Uganda. First developed and used in India, the Desarda method is reported to offer superior outcomes such as minimal postoperative groin pain and near zero recurrence rates. In comparison to the mesh-based repairs, it is a simple and affordable technique suitable for the resource-constrained communities. It is devoid of complications associated with foreign body implants. Early clinical outcomes which include acute groin pain, time to resumption of normal gait, operative time and complications will be assessed. Participants will be followed at 2 hours, 3 days, 7 days and 14 days postoperatively.

The investigators hypothesize that the mean postoperative acute groin pain score, or the mean postoperative day of return to normal gait is different in adult patients who undergo the non-mesh (Desarda) repair from what it is in those who undergo the mesh (Lichtenstein) technique of hernia repair.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 and above;
  • with a primary, reducible inguinal or inguino-scrotal hernia;
  • who consent to participate in the study;
  • who have a telephone contact.

排除标准

  • Giant inguino-scrotal hernias;
  • Obstructive uropathy or chronic obstructive pulmonary disease;
  • Impaired mental state and are unable to give an accurate assessment of the key outcomes of the operation.

结局指标

主要结局

Acute groin pain after surgery (measured on pain visual analogue scale of 0-10)

时间窗: 2 Weeks

Time (in days) taken to return to normal gait

时间窗: 2 Weeks

次要结局

  • Operative time (in Minutes)(2 hours)
  • Complications during and after surgery(2 Weeks)

研究者

申办方类型
Other

研究点 (1)

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