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

Kurien 2011.

Methods

  • Study design: parallel RCT

  • Study duration: January 2009 to February 2010

  • Study follow‐up: 1 year
Participants

  • Country: India

  • Setting: single centre, urology inpatient and outpatient setting

  • Health status: living kidney donors

  • Number: treatment group (25); control group (25)

  • Mean age ± SD (years): treatment group (44.36 ± 10.06); control group (47.20 ± 11.38)

  • Sex (M/F): treatment group (7/18); control group (8/17)

  • Exclusion criteria: right sided nephrectomy; multiple renal arteries; circum‐aortic renal vein; retro‐aortic renal vein; patient request for open nephrectomy; associated ipsilateral adrenal adenoma; BMI > 25 kg/m2 (after 30 patients increased to > 27 kg/m2); no referent surgeon
Interventions Treatment group

  • LESS‐DN

    • Operating position: not reported

    • Ports: R‐port (TriPort or QuadPort) (Advanced Surgical Concepts)

    • Extraction method: Endo Catch II 15 mm surgical pouch (Covidien/Autosuture; Hamilton MH FX)

    • Laparoscope: 5 mm, 30 degree telescope or 5 mm flexible tip telescope (EndoEYE)

    • Immunosuppression regimen: not reported


Control group

  • Laparoscopic donor nephrectomy

    • Operating position: not reported

    • Ports: 1 x 10 mm camera port, 3‐4 standard laparoscopic ports

    • Extraction method: Endo Catch II 15 mm Surgical Pouch (Covidien/Autosuture; Hamilton MH FX)

    • Laparoscope: standard 10 mm laparoscope

    • Immunosuppression regimen: not reported
Outcomes Primary outcome

  • Postoperative pain scores (VAS 1 to 10) recorded at 12, 24, 36, 48, 60, 70 and 96 hours postoperatively


Secondary outcomes

  • Operating time

  • Analgesia requirement

  • LOS

  • Quality of life scores (SF36 v2 pre/postoperative and at 6 and 9 months)

  • Body image questionnaire (score 5 to 20)

  • Cosmetic questionnaire (score 3 to 24)

  • Kidney graft function (eGFR measurement up 12 months postoperative)
Notes

  • Clinical parameters measured not defined in the methods

  • Sudden cardiac death in the postoperative period (1 participant)

  • Source of funding not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomised by chit method with block randomisation"
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No blinding performed: de‐identified participant questionnaires assessed
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk "Health survey and body image questionnaire were filled up by our trained transplant social worker who was blinded to the mode of nephrectomy"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All outcome data reported
Selective reporting (reporting bias) Low risk None identified
Other bias Unclear risk Funding source not reported