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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Voluntary Kidney Donors 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.
 
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