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Cochrane Database of Systematic Reviews Protocol - Intervention

Laparoscopic versus open nephrectomy for live kidney donors

Authors' declarations of interest

Version published: 19 July 2006 Version history

https://doi.org/10.1002/14651858.CD006124

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

This review aims to look at the benefits and harms of open donor nephrectomy versus laparoscopic donor nephrectomy as appropriate surgical techniques for live kidney donors.

Background

Kidney transplantation remains the treatment of choice for end‐stage kidney disease (ESKD). It improves both the quality and quantity of life in recipients (Wolfe 1999). Kidney transplantation has become a victim of its own success as currently, and for the foreseeable future, demand greatly outstrips supply. The number of patients on the UK kidney transplant waiting list is set to rise from the current level of about 4000 to greater than 6000 by 2010 (UKRR 2002). The quest has been to increase the donor pool to accommodate this ever‐expanding ESKD population.

Living organ donation has a much greater potential to increase the number of transplants when compared with other strategies such as the use of "marginal" organs from non‐heart beating elderly or hypertensive cadaveric donors. (Giessieng 2004) The first kidney transplant performed was a living organ donation when it served as a life saving procedure before the inception of dialysis (Salazar 2005). The major advantages of live kidney donation are superior recipient post‐transplant outcomes compared with cadaveric kidneys, the potential for transplantation pre‐dialysis and ability to plan the procedure allowing optimisation of recipient condition (Brook 2005). In addition, well‐matched kidney grafts from live donors are less susceptible to chronic allograft nephropathy when compared with cadaveric donors (UNOS 1996). Offering live donor kidneys is now the best way to ensure good graft function and best hope of long‐term graft survival (Brook 2005a).

Live donor nephrectomy is conventionally performed through an open flank incision with or without rib resection. Other described approaches include the anterior transperitoneal and extraperitoneal methods (Peters 2002). The major disincentive for relatives and partners contemplating kidney donation is the pain, scarring and morbidity associated with this large incision (Cecka 1995; Ratner 1997a). This method of donor nephrectomy has recently been challenged by less invasive operation using laparoscopic techniques.

Ratner 1995 first performed laparoscopic donor nephrectomy in 1995, and since then considerable numbers of transplant centres worldwide have adopted this technique. It allows kidney retrieval from the donor by multiple but smaller incisions (Buell 2005). The goal of this technique is to utilise all the advantages of laparoscopic surgery such as less pain, shorter hospital stay, reduced time away from work and a better cosmetic result to increase the potential number of living related kidney donors (Giessieng 2004).

Balanced against this prospective gain in the number of transplants is the overriding concern of donor safety. Live organ donation stands alone as an operation that exposes a patient to considerable bodily harm with no expectation of personal benefit (Cecka 1995). Several approaches to laparoscopic nephrectomy have been described. The most widely used approaches of laparoscopic donor nephrectomy are transperitoneal (Fabrizio 1999), extraperitoneal (Gill 2000) and hand‐assisted (Hemal 2001) techniques. Exponents of this technique are confident that the laparoscopic procedure is associated with reduced wound problems, less pain, early return to daily activities and shorter hospital stay (Buell 2005).

Advocates of open donor nephrectomy have raised a number of concerns over the laparoscopic technique including the increased use of left kidneys (because of technical difficulties with access to the right side), major complications (such as pancreatitis, bowel obstruction, pneumonia, respiratory distress syndrome, splenic lacerations) and minor complications (such as pneumothorax, liver lacerations, diaphragmatic injuries) as reported by the Maryland series (Jacobs 2004).

Objectives

This review aims to look at the benefits and harms of open donor nephrectomy versus laparoscopic donor nephrectomy as appropriate surgical techniques for live kidney donors.

Methods

Criteria for considering studies for this review

Types of studies

All randomised controlled trials (RCTs) and quasi‐RCTS (RCTs in which allocation to treatment was obtained by alternation, use of alternate medical records, date of birth or other predictable methods) looking at open and laparoscopic donor nephrectomy surgical techniques for live kidney donors.

Types of participants

Inclusion criteria

We will include all studies designed to examine the advantages and disadvantages of laparoscopic surgery (including retroperitoneal, extraperitoneal, hand‐assisted) over open surgery (including anterior transperitoneal, extraperitoneal) for live kidney donors. Paediatric donors will be included. There will be no upper age limit for recipients in our search. Previous transplant recipients will also be included.

Exclusion criteria

Studies must adequately detail the demographics of donor, recipient and surgical technique to allow comparison and stratification of outcomes after the chosen surgical technique (open versus laparoscopic). All studies describing other kidney transplant surgical operations (e.g. cadaveric, non‐heart beating) apart from live related donor procedures will be excluded from this study.

Types of interventions

The interventions under investigation are the laparoscopic techniques described for donor nephrectomy. The control group in each study will be an open nephrectomy procedure. For a study to be included, the procedures must be for a living related donation.

Types of outcome measures

Primary outcomes

  1. Donor safety (e.g. length of hospital stay; return to work and daily activities; wound scarring; analgesia requirements; kidney function measures (creatinine clearance, GFR)).

  2. Intraoperative complications (e.g. blood loss; duration of procedure; conversion rate; first warm Ischaemic time).

  3. Postoperative complications (e.g. splenic lacerations; urine infections and retention; postoperative ileus; bowel obstructions).

Secondary outcomes

  1. Donor evaluation (e.g. side of kidney used; number of kidneys accepted for surgery; anatomy of kidney vessels).

  2. Graft outcome measures (e.g. delayed graft function; acute and chronic allograft nephropathy).

  3. Recipient complications (e.g. renovascular thrombosis; ureteric complications).

Search methods for identification of studies

1). The Cochrane Renal Groups Specialised Register and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, (most recent) which will be searched using the following terms:‐
#1 Nephrectomy MeSH
#2 Surgical Procedures, Minimally Invasive MeSH
#3 Laparoscopy MeSH
#4 nephrectom*
#5 minimal access surg
#6 minimally invasive
#7 (#1 OR #2 OR #3 OR #4 OR #5 OR #6)
#8 Living Donors
#9 liv* near5 kidney
#10 liv* near5 donor*
#11 (#8 OR #9 OR #10)
#12 (#7 AND #11)

CENTRAL and the Renal Groups Specialised Register contain the hand searched results of conference proceedings from general and speciality meetings. This is an ongoing activity across the Cochrane Collaboration and is both retrospective and prospective (http://www.cochrane.us/masterlist.asp). Therefore we will not specifically search conference proceedings.

2). MEDLINE (1966 to most recent) using the optimally sensitive strategy developed for the Cochrane Collaboration for the identification of RCTs (Dickersin 1994) with a specific search strategy developed with input from the Cochrane Renal Group Trial Search Coordinators.
1. Nephrectomy/
2. Surgical Procedures, Minimally Invasive/
3. Laparoscopy/
4. nephrectom$.tw.
5. minimal access surg$.tw.
6. minimally invasive$.tw.
7. or/1‐6
8. Living Donors/
9. (liv$ adj5 kidney$).tw.
10. (liv$ adj5 donor$).tw.
11. or/8‐10
12. and/7,11
13. randomized controlled trial.pt.
14. controlled clinical trial.pt.
15. randomized controlled trials/
16. random allocation/
17. double blind method/
18. single blind method/
19. or/13‐18
20. animals/ not (animals/ and human/)
21. 19 not 20
22. clinical trial.pt.
23. exp clinical trials/
24. (clinic$ adj25 trial$).ti,ab.
25. cross‐over studies/
26. (crossover or cross‐over or cross over).tw.
27. ((singl$ or doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ti,ab.
28. placebos/
29. placebo$.ti,ab.
30. random$.ti,ab.
31. research design/
32. or/22‐31
33. 32 not 20
34. 21 or 33
35. and/12,34

3). EMBASE (1980 to most recent) using a search strategy adapted from that developed for the Cochrane Collaboration for the identification of RCTs (Lefebvre 1996) together with a specific search strategy developed with input from the Cochrane Renal Group Trial Search Coordinators.
1. exp NEPHRECTOMY/
2. minimally invasive surgery/
3. laparoscopic surgery/
4. Laparoscopy/
5. nephrectom$.tw.
6. minimal access surg$.tw.
7. minimally invasive$.tw.
8. or/1‐7
9. donor/ or kidney donor/ or living donor/
10. (liv$ adj5 kidney$).tw.
11. (liv$ adj5 donor$).tw.
12. or/9‐11
13. and/8,12
14. exp clinical trial/
15. evidence based medicine/
16. outcomes research/
17. crossover procedure/
18. double blind procedure/
19. single blind procedure/
20. prospective study/
21. major clinical study/
22. exp comparative study/
23. placebo/
24. "evaluation and follow up"/
25. follow up/
26. randomisation/
27. or/14‐26
28. controlled study/ not case control study/
29. or/27‐28
30. (clinic$ adj5 trial$).ti,ab.
31. ((singl$ or doubl$ or trebl$ or tripl$) adj (blind$ or
mask$)).ti,ab.
32. random$.ti,ab.
33. placebo$.ti,ab.
34. or/30‐33
35. 29 or 34
36. limit 35 to human
37. and/13,36

4). Reference lists of nephrology textbooks, review articles and relevant studies.
5). Letters seeking information about unpublished or incomplete studies to investigators known to be involved in previous studies.

Data collection and analysis

Included and excluded studies

The review will be undertaken by four authors (AS, CW, DR and NS). The search strategy described will be used to obtain titles and abstracts of studies that may be relevant to the review. The titles and abstracts will be screened independently by (AS) and (CW), who will discard studies that are not applicable, however studies and reviews that might include relevant data or information on studies will be retained initially. Authors (AS) and (CW) will independently assess retrieved abstracts and, if necessary the full text, of these studies to determine which studies satisfy the inclusion criteria. Data extraction will be carried out by the same authors independently using standard data extraction forms. Studies reported in non‐English language journals will be translated before assessment. Where more than one publication of one study exists, only the publication with the most complete data will be included. Any further information required from the original author will be requested by written correspondence and any relevant information obtained in this manner will be included in the review. Disagreements will be resolved in consultation with (NS) and (DR).

Study quality

The quality of studies to be included will be assessed independently by (AS) and (CW) without blinding to authorship or journal using the checklist developed for the Cochrane Renal Group. Discrepancies will be resolved by discussion with NS and DR. The quality items to be assessed are allocation concealment, blinding (participants, investigators, outcome assessors and data analysis), intention‐to‐treat analysis and completeness of follow‐up.

Quality checklist

Allocation concealment

  • Adequate (A): Randomisation method described that would not allow investigator/participant to know or influence intervention group before eligible participant entered in the study

  • Unclear (B): Randomisation stated but no information on method used is available

  • Inadequate (C): Method of randomisation used such as alternate medical record numbers or unsealed envelopes; any information in the study that indicated that investigators or participants could influence intervention group

Blinding

  • Blinding of investigators: Yes/No/not stated

  • Blinding of participants: Yes/No/not stated

  • Blinding of outcome assessor: Yes/No/not stated

  • Blinding of data analysis: Yes/No/not stated

The above are considered not blinded if the treatment group can be identified in > 20% of participants because of the side effects of treatment.

Intention‐to‐treat

  • Yes: Specifically reported by authors that intention‐to‐treat analysis was undertaken and this was confirmed on study assessment.

  • Yes: Not stated but confirmed on study assessment

  • No: Not reported and lack of intention‐to‐treat analysis confirmed on study assessment. (Patients who were randomised were not included in the analysis because they did not receive the study intervention, they withdrew from the study or were not included because of protocol violation)

  • No: Stated but not confirmed upon study assessment

  • Not stated

Completeness to follow‐up

Per cent of participants excluded or lost to follow‐up.

Statistical assessment

For dichotomous outcomes (e.g. conversion rate) results will be expressed as risk ratio (RR) with 95% confidence intervals (CI). Data will be pooled using the random effects model but the fixed effects model will also be analysed to ensure robustness of the model chosen and susceptibility to outliers. Where continuous scales of measurement are used to assess the effects of treatment (e.g. blood loss) the weighted mean difference (MD) will be used, or the standardised mean difference (SMD) if different scales have been used. Heterogeneity will be analysed using a chi‐squared test on N‐1 degrees of freedom, with a P‐value of 0.05 used for statistical significance and with the I² test (Higgins 2003).

If possible, subgroup analysis will be used to explore possible sources of heterogeneity (e.g. operation subtype). Heterogeneity among participants could be related to Body Mass Index (BMI), anatomy of kidney vessels and previous abdominal surgery. Heterogeneity in treatments could be related to subtypes of operations (e.g. hand‐assisted versus laparoscopic technique). Complications will be tabulated and assessed with descriptive techniques, as they are likely to range in severity and outcome.

If sufficient RCTs are identified, an attempt will be made to examine for publication bias using a funnel plot (Egger 1997).