Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision
NCT03317184 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2018-05-14
Summary
Despite efforts to optimize the transplantation of deceased donor kidneys, the number of available kidneys continues to fall short of the demand. Living donor kidneys have been used to overcome this shortage. Graft and patient survival is significantly higher following living donor kidney transplantation compared with deceased donor kidney transplantation. Open donor nephrectomy was the universal technique prior to the advent of laparoscopic techniques. Laparoscopic approaches 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 longer warm ischemia time, longer operative time, and increased bleeding with laparoscopic nephrectomy compared with hand-assisted laparoscopic living donor nephrectomy (HALDN). HALDN attempted to reduce warm ischemia time by using the hand port to extract the kidney instantly after dividing the blood vessels. This technique also offers tactile feedback, better manual control of bleeding, a relatively shorter learning curve, less kidney traction, faster kidney removal, and shorter warm ischemic periods. HALDN is often performed using periumbilical and Pfannenstiel incisions for hand-assisted port placement. Pfannenstiel incisions improve wound complications such as incisional hernia, cosmetic issues, and wound dehiscence. However, duration of surgery, postoperative pain score, and length of hospital stay are significantly lower in donors with periumbilical incisions.To the best of our knowledge, these two types of incision have not been compared in a randomized controlled trial in patients undergoing HALDN. Our objective is to compare the results of Pfannenstiel incision (intervention group) with periumbilical incision (control group). The return to normal physical activity will be evaluated in a clinical randomized trial using an expertise-based design.
Conditions
- Donor Nephrectomy
Interventions
- PROCEDURE
-
Periumbilical incision
A periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy.
- PROCEDURE
-
Pfannenstiel incision
Pfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis for hand-assisted laparoscopic donor nephrectomy.
Sponsors & Collaborators
-
University Hospital Heidelberg
lead OTHER
Principal Investigators
-
Yakup Kulu, MD · Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
-
Arianeb Mehrabi, MD · Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-11-01
- Primary Completion
- 2020-02-01
- Completion
- 2020-06-01
Countries
- Germany
Study Locations
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