NCT03317184: HAPERPACT

Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision

Status unknown NA Last updated 14 May 2018

What this trial tests

NA trial testing Periumbilical incision in Donor Nephrectomy in 52 participants. Status unknown.

Timeline

1 November 2017

Primary endpoint
1 February 2020

1 June 2020

Quick facts

Lead sponsor	University Hospital Heidelberg
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	1 November 2017
Primary completion	1 February 2020
Estimated completion	1 June 2020
Sites	1 location across Germany

Drugs / interventions tested

• Periumbilical incision
• Pfannenstiel incision

Conditions studied

• Donor Nephrectomy — all drugs for Donor Nephrectomy →

Sponsor

University Hospital Heidelberg

Who can join

20 and older, any sex, with Donor Nephrectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial.
   Kulu Y, Müller-Stich BP, Ghamarnejad O, Khajeh E, et al · · 2018 · cited 1× · PMID 30005640 · DOI 10.1186/s13063-018-2775-4
2. Abstracts DGAV
   · 2019