Table 1 World Health Organisation (WHO) trial registration data set

Primary registry and trial identifying number

NCT01857011

Date of registration in primary registry

8 May 2013

Secondary identifying numbers

U1111-1169-6223, Brazilian Clinical Trials Registry (REBEC): RBR-2JGRKQ

Source of monetary or material support

São Paulo Research Foundation (Fundação de Amparo à Pesquisa do Estado de São Paulo – FAPESP), grant #2014/07710-6

Primary sponsor

Federal University of São Paulo

Secondary sponsor

Instituto de Assistência Médica ao Servidor Público Estadual (IAMSPE)

Contact for public queries

Juan Carlos Montano Pedroso (juancmontano@gmail.com)

Contact for scientific queries

Juan Carlos Montano Pedroso (juancmontano@gmail.com0

Public title

Iron Supplementation for the Treatment of Acute Anaemia After Postbariatric Tummy Tuck

Scientific title

Postoperative intravenously administered iron sucrose 200 mg administered twice or postoperative orally administered iron for the treatment of post-bariatric abdominoplasty anaemia (ISAPA): a randomised controlled trial

Countries of recruitment

Brazil

Health conditions or problems studied

Postoperative anaemia, iron deficiency

Interventions

Study group: administration of 200 mg of iron sulphate intravenously after post-bariatric abdominoplasty, immediately after the operation and on the first postoperative day

Control group: ferrous sulphate supplementation orally administered postoperatively at a dose of 1 tablet of 100 mg 12/12 h for 8 weeks.

Key inclusion and exclusion criteria

Inclusion criteria: women; 18 to 55 years old; previous bariatric surgery; body mass index (BMI) less than 32 kg/m²; stability of weight loss for at least 6 months

Exclusion criteria: smoking; cholelithiasis demonstrated by ultrasound; uncontrolled systemic diseases; bone marrow diseases; haematological disorders; presence of renal or hepatic insufficiency; acute infection; prior use of intravenously administered iron in the last 3 months; haemoglobin level less than 11.5 g/dL; ferritin level less than 11 ng/mL or greater than 100 ng/mL; transferrin saturation index below 20 % or exceeding 50 %; vitamin B₁₂ level less than 210 pg/mL; folic acid level less than 3.3 ng/mL; albumin level less than 3 g/dL; C-reactive protein greater than 5 mg/L; mean corpuscular volume less than 80 fL

Study type

Interventional

Allocation: randomised

Masking: unblinded

Assignment: parallel

Purpose: treatment

Phase: not applicable

Date of first enrolment

April 2014

Target sample size

56

Recruitment status

Recruiting

Primary outcome

Haemoglobin level increase in the eighth week of postoperative abdominoplasty after bariatric surgery, measured by automated haematology counter in g/dL

Key secondary outcomes

Presence of iron deficiency assessed by serum ferritin, postoperative haemoglobin levels, fatigue measured by the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) questionnaire, quality of life measured by the Short-Form 36 Health Survey (SF-36), adverse events, surgical complications. Timepoints: 1, 4 and 8 postoperative weeks