Hand-assisted Laparoscopic Donor Nephrectomy Periumbilical Versus Pfannenstiel Incision

NCT03317184 | Unknown

• 1 other identifier: S-291/2017
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Donor Nephrectomy

Keywords

Physical Activity; Pfannenstiel incision; Periumbilical incision

Outcome Measures

Primary Outcomes (1)

• Days to return to normal physical activity

  Patients will be asked to complete the "Katz basic activities of daily living" self-maintenance questionnaire each day for 4 weeks after the operation. This questionnaire assesses the ability to perform daily living activities (0 = no activity and 6 = normal activity). The normal physical activity is perceived as good.

  Four weeks

Secondary Outcomes (19)

• Warm ischemia time

  One day

• Intraoperative complications

  One day

• Estimated blood loss

  One day

• Operating time

  One day

• Postoperative pain

  Seven days

Study Arms (2)

Periumbilical incisions

EXPERIMENTAL

Procedure: Periumbilical incision

Pfannenstiel incision

EXPERIMENTAL

Procedure: Pfannenstiel incision

Interventions

Periumbilical incision PROCEDURE

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

Periumbilical incisions

Pfannenstiel incision PROCEDURE

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

Pfannenstiel incision

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 20 years
• No permanent pain therapy
• Kidneys with only a single artery and vein in the graft
• Informed consent for participation provided

You may not qualify if:

• Infection or scar present precluding incision placement at one of the randomization sites
• Bleeding disorders
• Chronic use of immunosuppressive agents (e.g. steroids)

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

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

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 30005640 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Yakup Kulu, MD

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

  PRINCIPAL INVESTIGATOR

• Arianeb Mehrabi, MD

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

  STUDY DIRECTOR

Central Study Contacts

Yakup Kulu, MD

CONTACT

0049 - 6221 - 5637215; Yakup.Kulu@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Expertise-based, single intuition, assessor-blinded, randomized clinical trial.

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 23, 2017
• Study Start: November 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

DE (1)