Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision
キーワード
概要
説明
Despite all efforts to optimize the transplantation of deceased donor kidneys, the number of available kidneys continues to fall short of demand. Living donor kidneys have been used to overcome this organ shortage. Graft and patient survival is significantly higher following living donor kidney transplantation compared with deceased donor kidney Transplantation.
The major disadvantage of using living donors is that a healthy individual must undergo a major surgical procedure to provide the organ for transplantation. The donor does not medically benefit from the procedure, but there is a medical impact on both donor and recipient. Therefore, a nephrectomy technique associated with the lowest donor risk and the best organ quality should be used during Transplantation.
Open donor nephrectomy was the universal technique before the advent of laparoscopic techniques. Laparoscopic living donor nephrectomy was introduced in 1995 and commercial ports were developed shortly after. In 1998, Wolf et al. described the hand-assisted laparoscopic living donor nephrectomy (HALDN) technique and since then it has become widely adopted. Laparoscopic methods have definite advantages over open surgery in terms of blood loss, postoperative pain, analgesic requirements, duration of hospital stay, and convalescence.
There is some controversy regarding the possibility of relatively longer warm ischemia time, longer operative time, and increased bleeding with laparoscopic nephrectomy. HALDN reduces warm ischemia time by extracting the kidney using the hand port as soon as the blood vessels are divided. This technique is associated with tactile feedback, better manual control of bleeding, relatively shorter learning curve, less kidney traction, faster kidney removal, and shorter warm ischemic periods. At present, there is no strong evidence to support the use of one laparoscopic approach in preference to the other. However, evidence suggests that HALDN is the most cost-effective method of donor surgery and achieves equivalent clinical benefits of pure laparoscopic approaches with less operative time.
HALDN is usually performed using a periumbilical or Pfannenstiel incision for hand-assisted port placement and kidney extraction. A periumbilical incision is made at the midline. In contrast, a Pfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis. Pfannenstiel incisions improve wound complications, such as incisional hernia, cosmetic results, and wound dehiscence. However, the duration of surgery, postoperative pain score, and length of hospital stay were significantly lower in donors with periumbilical incision. The inserted hand plays a vital role in the procedure, including retraction and dissection, therefore the hand port midline incision is placed close to the periumbilical area. Dissecting the upper pole of the kidney through a Pfannenstiel incision may be difficult in morbidly obese and large donors.
Patients with Pfannenstiel incisions return to normal physical activity quicker than those with periumbilical incisions. However, to the best of our knowledge, these two different incision types in patients undergoing HALDN have not been compared in a randomized controlled trial.Our objective is to compare the return of patients to physical activity following a HALDN procedure with Pfannenstiel incision (intervention group) or periumbilical incision (control group) in a clinical randomized trial using an expertise-based design.
日付
最終確認済み: | 04/30/2018 |
最初に提出された: | 10/05/2017 |
提出された推定登録数: | 10/16/2017 |
最初の投稿: | 10/22/2017 |
最終更新が送信されました: | 05/07/2018 |
最終更新日: | 05/13/2018 |
実際の研究開始日: | 10/31/2017 |
一次完了予定日: | 01/31/2020 |
研究完了予定日: | 05/31/2020 |
状態または病気
介入/治療
Procedure: Periumbilical incisions
Procedure: Pfannenstiel incision
段階
アームグループ
腕 | 介入/治療 |
---|---|
Experimental: Periumbilical incisions | Procedure: Periumbilical incisions A periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy. |
Experimental: Pfannenstiel incision | Procedure: Pfannenstiel incision Pfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis for hand-assisted laparoscopic donor nephrectomy. |
適格基準
研究の対象となる年齢 | 20 Years に 20 Years |
研究に適格な性別 | All |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - Age > 20 years - No permanent pain therapy - Kidneys with only a single artery and vein in the graft - Informed consent for participation provided Exclusion Criteria: - Infection or scar present precluding incision placement at one of the randomization sites - Bleeding disorders - Chronic use of immunosuppressive agents (e.g. steroids) |
結果
主な結果の測定
1. Days to return to normal physical activity [Four weeks]
二次的な結果の測定
1. Warm ischemia time [One day]
2. Intraoperative complications [One day]
3. Estimated blood loss [One day]
4. Operating time [One day]
5. Postoperative pain [Seven days]
6. Rescue analgesic [Seven days]
7. Peak expiratory flow rate [Seven days]
8. Postoperative complications [60 days]
9. Length of hospital stay [60 days]
10. Time to return to work [60 days]
11. Physical activity score [60 days]
12. Patient satisfaction [60 days]
13. Cosmetic score [60 days]
14. Incisional hernia [60 days]
15. Mortality [60 days]
16. Recipient serum creatinine level [30 days]
17. Glomerular filtration rate [30 days]
18. Delayed graft function [30 days]
19. Primary non-function [30 days]