Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision

NCT ID: NCT03317184

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-06-01

Brief 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.

Detailed Description

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.

Conditions

Donor Nephrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Periumbilical incisions

Group Type: EXPERIMENTAL

Periumbilical incision

Intervention Type: PROCEDURE

A periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy.

Pfannenstiel incision

Group Type: EXPERIMENTAL

Pfannenstiel incision

Intervention Type: PROCEDURE

Pfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis for hand-assisted laparoscopic donor nephrectomy.

Interventions

Periumbilical incision

A periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy.

Intervention Type: PROCEDURE

Pfannenstiel incision

Pfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis for hand-assisted laparoscopic donor nephrectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. A. Mehrabi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yakup Kulu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany

Arianeb Mehrabi, MD

Role: STUDY_DIRECTOR

Department of General, Visceral and Transplant Surgery, University Hospital Heidelberg, Germany

Locations

Division of Visceral Transplantation, Department of General, Visceral and Transplantation Surgery, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Yakup Kulu, MD

Role: CONTACT

Yakup.Kulu@med.uni-heidelberg.de

0049 - 6221 - 5637215

Facility Contacts

Arianeb Mehrabi, MD

Role: primary

arianeb.mehrabi@med.uni-heidelberg.de

0049 - 6221 - 5636223

References

Kulu Y, Muller-Stich BP, Ghamarnejad O, Khajeh E, Polychronidis G, Golriz M, Nickel F, Benner L, Knebel P, Diener M, Morath C, Zeier M, Buchler MW, Mehrabi A. Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial. Trials. 2018 Jul 13;19(1):377. doi: 10.1186/s13063-018-2775-4.

Reference Type: DERIVED

PMID: 30005640 (View on PubMed)

Other Identifiers

S-291/2017

Identifier Type: -

Identifier Source: org_study_id