Children's Surgery in Sub-Saharan Africa

NCT03185637 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1407

Last updated 2017-08-21

No results posted yet for this study

Summary

Background: Five billion people worldwide do not have access to safe, affordable surgical care. A significant proportion live in sub-Saharan Africa (SSA), where up to 50% of the population are children. There is limited literature on neonatal and paediatric surgery in SSA and children's surgery does not appear on any of the National Health Strategic Plans for the 47 independent countries across SSA.

Objectives: To form a collaboration of surgeons and allied health professionals involved in children's surgery across SSA and collectively undertake the largest prospective cohort study of paediatric surgery in this region.

Materials and Methods: Data will be collected via REDCap website on all patients with gastroschisis, anorectal malformation, appendicitis, inguinal hernia and intussusception, during a 1-month period of collaborators choice between October 2016 to April 2017, with a 30-day follow up until the end of May 2017. Estimated study population: 1450 patients from 50 institutions. Full ethical approval has been granted by the host centre; local ethical approval will be required at collaborating centres for participation. All collaborators will be co-authors.

Primary outcome will be in-hospital all-cause mortality. Secondary outcomes will include post-intervention complications. Data will be collected on institutional facilities, patient demographics, duration from condition onset to presentation, peri-operative resuscitation, intervention and outcome.

Differences in outcomes between SSA and benchmark data from high-income countries will be calculated using chi-squared analysis. Multi-level multivariate logistic regression analysis will be used to identify interventions and peri-operative factors associated with improved outcomes; p\<0.05 will be deemed significant.

Outcome: Results will be used to advocate for enhanced children's surgical services in SSA. We shall identify context-appropriate interventions associated with improved outcome. The collaboration will help to enhance research capacity in the region.

Conditions

  • Gastroschisis
  • Anorectal Malformation
  • Appendicitis
  • Intussusception
  • Inguinal Hernia

Interventions

PROCEDURE

Various interventions for each of the conditions.

This is an observational study. Patients were not allocated to different interventions. Common interventions for each of the conditions, which will be compared during analysis include the following: Gastroschisis - primary operative closure, surgical silo, preformed silo. Anorectal malformation - various types of stoma, anoplasty, PSARP, other. Appendicitis - antibiotics, open appendicectomy, laparoscopic appendicectomy. Intussusception - air enema reduction, hydro-enema reduction, laparotomy. Inguinal hernia - open repair, laparoscopic repair.

Sponsors & Collaborators

  • Sylvanus Olympio University Teaching Hospital, Lome, Togo.

    collaborator UNKNOWN
  • National Hospital of Niamey

    collaborator OTHER
  • Centre Hospitalier Universitaire de la Mère et de l Enfant, Cotonou, Benin.

    collaborator UNKNOWN
  • HEAL Africa Hospital, Goma, Democratic Republic of the Congo.

    collaborator UNKNOWN
  • Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle

    collaborator OTHER
  • University Hospital De Bouaké, Ivory Coast.

    collaborator UNKNOWN
  • Teaching Hospital Treichville, Abidjan, Ivory Coast.

    collaborator UNKNOWN
  • Harare Central Hospital, Zimbabwe.

    collaborator UNKNOWN
  • University Teaching Hospital, Lusaka, Zambia

    collaborator OTHER
  • Mulago Hospital, Uganda

    collaborator OTHER
  • Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.

    collaborator UNKNOWN
  • Mbingo Baptist Hospital, Cameroon.

    collaborator UNKNOWN
  • Ministry of Health, Ghana

    collaborator OTHER_GOV
  • Korle-Bu Teaching Hospital, Accra, Ghana

    collaborator OTHER
  • Edna Adan Maternity Hospital, Hargeisa, Somaliland.

    collaborator UNKNOWN
  • Embu Level 5 Hospital, Kenya.

    collaborator UNKNOWN
  • Tenwek Hospital

    collaborator OTHER
  • Soba University Hospital

    collaborator OTHER
  • Kamuzu Central Hospital

    collaborator OTHER
  • Queen Elizabeth Central Hospital, Blantyre, Malawi

    collaborator UNKNOWN
  • Muhimbili National Hospital, Dar es Salaam, Tanzania.

    collaborator UNKNOWN
  • Grey's Hospital

    collaborator OTHER
  • Stranger Hospital, Kwazulu-Natal, South Africa.

    collaborator UNKNOWN
  • Tygerberg Hospital, South Africa.

    collaborator UNKNOWN
  • Clinton Hospital, Johannesburg

    collaborator UNKNOWN
  • Charlotte Maxeke Johannesburg Academic Hospital

    collaborator UNKNOWN
  • Chris Hani Baragwanath Academic Hospital

    collaborator OTHER
  • East London Hospital Complex, South Africa.

    collaborator UNKNOWN
  • Red Cross War Memorial Childrens Hospital

    collaborator OTHER
  • Delta State University Teaching Hospital Ogharra

    collaborator UNKNOWN
  • Bowen University Teaching Hospital, Ogbomoso

    collaborator UNKNOWN
  • Ondo State Trauma and Surgical Centre

    collaborator UNKNOWN
  • Mnamdi Azikiwe University Teaching Hospital

    collaborator UNKNOWN
  • University Of Nigeria Teaching Hospital

    collaborator NETWORK
  • University of Port Harcourt Teaching Hospital

    collaborator OTHER
  • University College Hospital, Ibadan

    collaborator OTHER
  • Ahmadu Bello University Teaching Hospital

    collaborator OTHER
  • University of Abuja Teaching Hospital

    collaborator OTHER
  • National Hospital, Abuja

    collaborator OTHER_GOV
  • University of Calabar Teaching Hospital

    collaborator UNKNOWN
  • Federal Medical Centre, Abeokuta

    collaborator UNKNOWN
  • Federal Medical Centre, Owo

    collaborator INDUSTRY
  • Benue State University Teaching Hospital

    collaborator OTHER
  • Olabisi Onabanjo University Teaching Hospital

    collaborator UNKNOWN
  • University of Ilorin Teaching Hospital

    collaborator OTHER
  • Federal Medical Centre Lokoja

    collaborator UNKNOWN
  • Lagos State University

    collaborator OTHER
  • Obafemi Awolowo University Teaching Hospital

    collaborator OTHER
  • Aminu Kano Teaching Hospital

    collaborator OTHER
  • King's College London

    lead OTHER

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2017-05-31
Completion
2017-06-30

Countries

  • United Kingdom

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03185637 on ClinicalTrials.gov