跳至主要内容
临床试验/CTRI/2018/05/013620
CTRI/2018/05/013620招募中不适用

A PROSPECTIVE STUDY COMPARING OUTCOMES AND QUALITY OF LIFE AFTER LAPAROSCOPIC DONOR NEPHRECTOMY VERSUS OPEN DONOR NEPHRECTOMY

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
1. Pain score at 1 week

研究概览

简要总结

Renal transplant is the accepted standard of care in patients with end stage renal disease. Its superiority over dialysis has been already proved. Grafts obtained from live donors have a significantly longer life than those obtained from cadaveric donors. However, live donor nephrectomy places an individual through a major operation done for some other individual’s benefit. For this reason, it has always been a major concern to reduce the perioperative morbidity and mortality to the donor while still achieving a favorable graft outcome. There are several approaches to retrieve the kidney, like flank approach, subcostal approach and the latest laparoscopic organ retrieval. However major concerns exist over the merits and demerits of each approach, especially laparoscopic organ retrieval. With the advent of laparoscopy, a minimally invasive method is available to reduce the perioperative morbidity to the patient. Studies have shown laparoscopic donor nephrectomy to be equally safe and efficacious as the traditional open approach. It provides all the advantages of minimally invasive surgery, such as less pain, decreased blood loss, fewer wound complications, shorter hospital stay and faster recovery. However, laparoscopic donor nephrectomy is an advanced minimally invasive procedure which requires high level of laparoscopic skills. Large prospective studies comparing open versus laparoscopic donor nephrectomy are lacking in number, especially in the Indian scenario and further studies are required to compare the two modalities. Quality of life and cosmesis are important aspects after any operative intervention; however, they are especially important in donor nephrectomy, because the individual undergoes a major procedure for some other individual’s benefit. His/her post operative quality of life should be, if not, equal to his preoperative quality of life. However, there is a lacuna in the literature about the quality of life following open/laparoscopic donor nephrectomy, especially in the Indian scenario. Hence, this study proposes to prospectively compare laparoscopic donor nephrectomy with open donor nephrectomy with respect to perioperative morbidity and mortality to the donor and the recipient’s graft function and to assess and compare the quality of life of patient’s pre and post renal transplant by using WHO QOL-BREF protocol and the Hospital Anxiety and Depression Scale; to compare the cosmetic outcomes of the two procedures using the Body Image Questionnaire and to assess the overall patient satisfaction with the procedure using the Verbal Rating Scale.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing donor nephrectomy who fulfill the standard donor criteria and give consent.

排除标准

  • Donors of recipients undergoing redo renal transplant
  • Right donor nephrectomy.

结局指标

主要结局

1. Pain score at 1 week

时间窗: 1 week | 2 week | 3 months | 6 months

2. Pain score at 2 weeks

时间窗: 1 week | 2 week | 3 months | 6 months

3. Pain score at 3 months

时间窗: 1 week | 2 week | 3 months | 6 months

4. Recipient serum creatinine level at 3

时间窗: 1 week | 2 week | 3 months | 6 months

5. Recipient serum creatinine level at 6 months

时间窗: 1 week | 2 week | 3 months | 6 months

次要结局

  • Conversion to open mode of donor nephrectomy(Zero)
  • Intraoperative complications like bleeding, ureteric injury, bowel injury, splenic(injury and others)
  • Postoperative complications like pneumothorax, fever, ileus, surgical site infection,(respiratory tract infection, urinary tract infection and others)
  • Graft function in terms of serum creatinine level(3 months)
  • Quality of life score, compared to preoperative period(3 and 6 months)
  • Cosmetic outcome following surgery(3 and 6 months)
  • Patient satisfaction following surgery(3 and 6 months)
  • Total expenditure for the surgery(In hospital stay)

研究者

申办方类型
Government medical college

研究点 (1)

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