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. 2016 May 27;2016(5):CD010850. doi: 10.1002/14651858.CD010850.pub2

Aull 2014.

Methods
  • Study design: parallel RCT

  • Study duration: January 2011 to May 2012

  • Study follow‐up: 5 years

Participants
  • Country: USA

  • Setting: single centre; transplant inpatient and outpatient setting

  • Health status: living kidney donors

  • Number: treatment group (51); control group (49)

  • Mean age ± SD (years): treatment group (46.80 ± 11.90); control group (47.40 ± 11.50)

  • Sex (M/F): treatment group (22/29); control group (20/29)

  • Exclusion criteria: authors reported that 'there were no exclusion criteria'

Interventions Treatment group
  • LESS‐DN

    • Operating position: modified flank position

    • Ports: GelPOINT® device (Applied Medical)

    • Extraction method: Endo Catch (Covidien)

    • Laparoscope: 10 mm bariatric laparoscope with right angle attachment

    • Immunosuppression regimen: not reported


Control group
  • Laparoscopic donor nephrectomy

    • Operating position: lateral decubitus

    • Ports: 1 x 12 mm camera port, 2 x 5 mm standard laparoscopic ports

    • Extraction method: 5 to 6 cm Pfannenstiel incision + Endo Catch (Covidien)

    • Laparoscope: not reported

    • Immunosuppression regimen: not reported

Outcomes Primary outcome
  • Patient self‐reported "return to 100% recovery"


Secondary outcomes
  • Operative data

  • Postoperative data (within 30 days)

  • Donor subjective questionnaire scores

  • Long‐term follow‐up (30 days to 5 years)

    • Three patients lost to follow‐up

    • 25% patients did not return two month follow‐up questionnaire

  • Kidney transplant outcomes

    • Delayed graft function

    • Ureteral complications

    • SCr (1, 6, 12 months postoperative)

    • Graft survival

Notes
  • One author received a grant from Clinical Translational Sciences Centre (UL1‐TR000457‐08)

  • Power calculation performed

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Stratified and blocked randomisation was performed"
Patients stratified according to three parameters: laterality, BMI > 30 and vascular complexity
Allocation concealment (selection bias) Low risk "Consenting subjects were randomised by the research coordinator using stratified and blocked randomisation generated by the study statistician"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not reported but not relevant to outcome data reporting
Incomplete outcome data (attrition bias) 
 All outcomes High risk "Missing data for three patients in the LDN group who reported not being fully recovered at 2 months, but who did not provide the actual time it took them to recover"
Participants were lost from the laparoscopic donor nephrectomy arm which may have introduced attrition bias
12/51 and 13/49 participants did not return two month follow‐up questionnaires from LESS‐DN and laparoscopic donor nephrectomy groups respectively
Questionnaires related to the study's primary outcome
Selective reporting (reporting bias) Low risk No bias identified
Other bias Low risk A study author received a grant from Clinical Translational Sciences Centre (UL1‐TR000457‐08) but it is unlikely that this influenced study outcomes