| CTRI Number |
CTRI/2018/05/013620 [Registered on: 02/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
26/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
to compare the quality of life after two methods of donor nephrectomy viz laparoscopic and open |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY COMPARING OUTCOMES AND QUALITY OF LIFE
AFTER LAPAROSCOPIC DONOR NEPHRECTOMY VERSUS OPEN DONOR
NEPHRECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr Virinder kumar bansal |
| Designation |
professor |
| Affiliation |
department of surgery,All India Institute of Medical Sciences |
| Address |
room no. 5023
5th floor
teaching block
AIIMS
ansari nagar
South DELHI 110029 India |
| Phone |
9810348479 |
| Fax |
|
| Email |
drvkbansal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Devanshu bansal |
| Designation |
Junior resident |
| Affiliation |
Department of surgery, All India Institute of Medical Sciences |
| Address |
room no. 5023
5th floor
teaching block
AIIMS
ansari nagar
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
db.golem@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
dr Virinder kumar bansal |
| Designation |
professor |
| Affiliation |
department of surgery, All India Institute of Medical Sciences |
| Address |
room no. 5023
5th floor
teaching block
AIIMS
ansari nagar
South DELHI 110029 India |
| Phone |
9810348479 |
| Fax |
|
| Email |
drvkbansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar East, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
AIIMS, Ansari Nagar East, New Delhi, 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Virinder Kumar Bansal |
Department of Surgical disciplines, All India Institute of Medical Sciences |
Ansari Nagar East, New Delhi - 110029 New Delhi DELHI |
9810348479
drvkbansal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Voluntary Kidney Donors |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing donor nephrectomy who fulfill the standard donor criteria and give
consent |
|
| ExclusionCriteria |
| Details |
1. Donors of recipients undergoing redo renal transplant
2. Right donor nephrectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain score at 1 week
2. Pain score at 2 weeks
3. Pain score at 3 months
4. Recipient serum creatinine level at 3
5. Recipient serum creatinine level at 6 months |
1 week
2 week
3 months
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conversion to open mode of donor nephrectomy |
Zero |
Intraoperative complications like bleeding, ureteric injury, bowel injury, splenic
injury and others |
Zero |
Postoperative complications like pneumothorax, fever, ileus, surgical site infection,
respiratory tract infection, urinary tract infection and others |
Till in-hospital stay |
| Graft function in terms of serum creatinine level |
3 months |
| Quality of life score, compared to preoperative period |
3 and 6 months |
| Cosmetic outcome following surgery |
3 and 6 months |
| Patient satisfaction following surgery |
3 and 6 months |
| Total expenditure for the surgery |
In hospital stay |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2013 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The manuscript is being prepared |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Renal transplant is the accepted standard of care in patients with end stage renal disease. Its superiority over dialysis has been already proved. Grafts obtained from live donors have a significantly longer life than those obtained from cadaveric donors. However, live donor nephrectomy places an individual through a major operation done for some other individual’s benefit. For this reason, it has always been a major concern to reduce the perioperative morbidity and mortality to the donor while still achieving a favorable graft outcome. There are several approaches to retrieve the kidney, like flank approach, subcostal approach and the latest laparoscopic organ retrieval. However major concerns exist over the merits and demerits of each approach, especially laparoscopic organ retrieval. With the advent of laparoscopy, a minimally invasive method is available to reduce the perioperative morbidity to the patient. Studies have shown laparoscopic donor nephrectomy to be equally safe and efficacious as the traditional open approach. It provides all the advantages of minimally invasive surgery, such as less pain, decreased blood loss, fewer wound complications, shorter hospital stay and faster recovery. However, laparoscopic donor nephrectomy is an advanced minimally invasive procedure which requires high level of laparoscopic skills. Large prospective studies comparing open versus laparoscopic donor nephrectomy are lacking in number, especially in the Indian scenario and further studies are required to compare the two modalities. Quality of life and cosmesis are important aspects after any operative intervention; however, they are especially important in donor nephrectomy, because the individual undergoes a major procedure for some other individual’s benefit. His/her post operative quality of life should be, if not, equal to his preoperative quality of life. However, there is a lacuna in the literature about the quality of life following open/laparoscopic donor nephrectomy, especially in the Indian scenario. Hence, this study proposes to prospectively compare laparoscopic donor nephrectomy with open donor nephrectomy with respect to perioperative morbidity and mortality to the donor and the recipient’s graft function and to assess and compare the quality of life of patient’s pre and post renal transplant by using WHO QOL-BREF protocol and the Hospital Anxiety and Depression Scale; to compare the cosmetic outcomes of the two procedures using the Body Image Questionnaire and to assess the overall patient satisfaction with the procedure using the Verbal Rating Scale. |