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
Secondary outcomes
|
|
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 |