Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy | NCT02699489

Studies
Enhanced Recovery Open Versus Laparoscopic Donor Nephrectomy

NCT02699489

Sponsor

Mansoura University

Status

Completed

Last Update Posted

Mar 4, 2016Estimated

Enrollment

224Actual

Phase

Phase 3

Conditions

Renal Transplant Donor of Left Kidney

Interventions

Laparoscopic donor nephrectomy
Open donor nephrectomy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jun 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jan 13, 2016

First Submission Date that Met QC Criteria

Feb 29, 2016

First Posted Date

Mar 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 29, 2016

Last Update Posted Date

Mar 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ahmed mansour, Lecturer in Urology, Urology and Nephrology Center, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A phase III randomized trial conducted to compare recovery outcomes between laparoscopic and open donor nephrectomy within a specified enhanced recovery protocol

Detailed Description

The MEnROL trial is a phase III randomized controlled trial of Open versus Laparoscopic donor nephrectomy within a standardized enhanced recovery program. Eligible donors were randomized in a 1:1 ratio.

Laparoscopic procedures are performed by a single surgeon (AMM) while Open donor nephrectomies (ODN) were performed by an experienced team that included the laparoscopic surgeon. ODN were performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted. Laparoscopic donor nephrectomy (LDN) was performed via a standard 4-port distribution. Control of the hilar vessels was performed using extra-large Hem-o-Lok clips (Weck- Covidien, Research Triangle Park, NC) and graft extraction was performed via a pre-prepared Pfannenstiel incision.

Donors are enrolled in our enhanced recovery program for donor nephrectomy. The program was compliant with the Enhanced Recovery After Surgery Group (ERAS) guidelines. All donors receive epidural analgesia and are maintained on non-narcotic postoperative analgesics. Criteria for hospital discharge include ambulation, adequate pain control with oral analgesics, and sustained intake of solid food.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

224Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparoscopic donor nephrectomy arm	Experimental	This group will undergo laparoscopic donor nephrectomy	Procedure: Laparoscopic donor nephrectomy
Open donor nephrectomy arm	Active Comparator	This group will undergo open donor nephrectomy	Procedure: Open donor nephrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic donor nephrectomy	Procedure	Laparoscopic donor nephrectomy performed via a standard 4-port distribution. Control of the hilar vessels is performed using extra-large Hem-o-Lok clips (Weck- Covidien, Research Triangle Park, NC) and graft extraction is performed via a pre-prepared Pfannenstiel incision

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Donor recovery as evaluated by the physical fatigue domain of the Multidimensional Fatigue Inventory 20 (MFI-20),		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Short Form-36 (SF-36) health survey	Scores of Short Form-36 questionnaire	6 weeks
Length of Hospital stay	Length of hospital stay in days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Donor aged 18 years or more.
Donors who have the ability to understand information and materials provided.
Donors who didn't express a preference for either open or laparoscopic surgery.
Donors who are fit for both open and laparoscopic intervention
Donors in whom evaluation revealed left kidney with single renal artery suitable for donation.
Donors able to give signed written informed consent.

Exclusion Criteria:

Donors who had a preference for either open or laparoscopic surgery.
Donors in whom the right kidney was chosen for donation.
Donors with double renal arteries in kidneys chosen for donation.
Donors who didn't sign consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data are readily shared with requesting authorities

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided