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. 2015 May 22;2015(5):CD008096. doi: 10.1002/14651858.CD008096.pub4

Sadasivan 2012.

Methods Single‐centre parallel randomised controlled trial.
Sample size: a minimum of 40 cases in each group, with 80%‐ to –90% power and 95% confidence (80% on tube dislodgement and 90% on infection). So, 50 cases were included in each group.
Setting: India, Department of ENT (Ear, Nose, Throat; Otorhinolaryngology).
Participants 100 participants
Gender: PEG: 34/16 (male/female ratio); NGT: 33/17 (male/female ratio)
Age (mean): not reported
Inclusion criteria: patients with advanced stage 2 or 3 squamous cell carcinoma of the head and neck and who were scheduled either for radical surgery with adjuvant radiotherapy (RT), chemo‐RT, or for concurrent chemo and radiation therapy were included in the study.
Exclusion criteria: patients with early stage 1 or 2 head and neck cancer were excluded from the study
Interventions PEG n = 50; NGT n = 50
The majority of NG tubes were inserted by nurses, all PEG tubes were inserted by gastroenterologists.
Outcomes Follow‐up: 1 week; 6 weeks and 6 month
Primary outcomes
  1. Intervention failures as defined by any event leading to failure to introduce the tube, recurrent displacement and treatment interruption (feeding interruption, blocking or leakage of the tube, no adherence to treatment) (based on Norton 1996).


Secondary outcomes
  1. Nutritional status, as measured by any validated instrument (such as upper‐arm skin fold thickness, mid‐arm circumference, body weight, serum albumin level, haemoglobin (Ramel 2008)).

  2. Quality of life, EORTC QLQH& N35 at 6 weeks (Dorman 1997)): pain, learning to use, inconvenience, uncomfortable feeds, altered body image, family life, social activities.

Notes Statistical differences at baseline: radical surgery and adjuvant radiotherapy or chemo and radiation therapy (PEG: 92%; NGT: 72%; P = 0.01); concurrent chemo‐ and radiation therapy (PEG: 8%; NGT: 28% P = 0.01); baseline weight: PEG: 56.5 versus NGT: 61 (P < 0.01)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported by the study investigators
Allocation concealment (selection bias) Unclear risk Not reported by the study investigators
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible for this type of intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported by the study investigators
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Study investigators did not perform ITT analysis
Selective reporting (reporting bias) Low risk None suspected: relevant variables were analysed. The protocol was not assessed.
Other bias Unclear risk None suspected