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Children's Surgery in Sub-Saharan Africa (PaedSurgAfrica)

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ClinicalTrials.gov Identifier: NCT03185637
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
Sylvanus Olympio University Teaching Hospital, Lome, Togo.
Niamey National Hospital, Niger.
Centre Hospitalier Universitaire de la Mère et de l Enfant, Cotonou, Benin.
HEAL Africa Hospital, Goma, Democratic Republic of the Congo.
Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle
University Hospital De Bouaké, Ivory Coast.
Teaching Hospital Treichville, Abidjan, Ivory Coast.
Harare Central Hospital, Zimbabwe.
University Teaching Hospital, Lusaka, Zambia
Mulago Hospital, Uganda
Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.
Mbingo Baptist Hospital, Cameroon.
Tamale Teaching Hospital, Ghana.
Korle-Bu Teaching Hospital, Accra, Ghana
Edna Adan Maternity Hospital, Hargeisa, Somaliland.
Embu Level 5 Hospital, Kenya.
Tenwek Hospital
Soba University Hospital, Khartoum, Sudan.
Kamuzu Central Hospital, Lilongwe, Malawi
Queen Elizabeth Central Hospital, Blantyre, Malawi
Muhimbili National Hospital, Dar es Salaam, Tanzania.
Grey's Hospital
Stranger Hospital, Kwazulu-Natal, South Africa.
Tygerberg Hospital, South Africa.
Clinton Hospital, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Chris Hani Baragwanath Academic Hospital
East London Hospital Complex, South Africa.
Red Cross War Memorial Childrens Hospital
Delta State University Teaching Hospital Ogharra
Bowen University Teaching Hospital, Ogbomoso
Ondo State Trauma and Surgical Centre
Mnamdi Azikiwe University Teaching Hospital
University Of Nigeria Teaching Hospital
University of Port Harcourt Teaching Hospital
University College Hospital, Ibadan
Ahmadu Bello University Teaching Hospital
University of Abuja Teaching Hospital
National Hospital, Abuja
University of Calabar Teaching Hospital
Federal Medical Centre, Abeokuta
Federal Medical Centre, Owo
Benue State University Teaching Hospital
Olabisi Onabanjo University Teaching Hospital
University of Ilorin Teaching Hospital
Federal Medical Centre Lokoja
Lagos University Teaching Hospital
Lagos State University Teaching Hospital
Obafemi Awolowo University Teaching Hospital
Aminu Kano Teaching Hospital
Information provided by (Responsible Party):
King's College London

Brief 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.


Condition or disease Intervention/treatment
Gastroschisis Anorectal Malformation Appendicitis Intussusception Inguinal Hernia Procedure: Various interventions for each of the conditions.

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 1407 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Paediatric Surgery Across Sub-Saharan Africa: A Multi-Centre Prospective Cohort Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : June 30, 2017


Group/Cohort Intervention/treatment
Gastroschisis
All patients presenting primarily to the institution with gastroschisis during the data collection period will be included in the study.
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.


Anorectal malformation
All patients presenting primarily to the institution with anorectal malformation during the data collection period will be included in the study.
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.


Appendicitis
All patients under 16-years of age presenting primarily to the institution with appendicitis during the data collection period will be included in the study.
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.


Intussusception
All patients under 16-years of age presenting primarily to the institution with intussusception during the data collection period will be included in the study.
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.


Inguinal hernia
All patients under 16-years of age undergoing surgery for an inguinal hernia at the institution during the data collection period will be included in the study.
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.





Primary Outcome Measures :
  1. All-cause in-hospital mortality [ Time Frame: In-hospital (if in the patient is still in hospital at 30-days post-intervention, a 30-day mortality will be utilised) ]

Secondary Outcome Measures :
  1. 30-day mortality [ Time Frame: 30-days ]
    Whether or not the patient died within 30-days of intervention

  2. Duration of hospital stay [ Time Frame: Patients are followed up for a maximum of 30-days post-intervention ]
    Total number of days in hospital inclusive of the day of admission and day of discharge

  3. Surgical site infection [ Time Frame: Within 30-days post-intervention ]
    Surgical site infection criteria include at least one of the following: 1) purulent drainage from the superficial or deep (fascia or muscle) incision but not from within the organ/space component of the surgical site, 2) at least one of: pain or tenderness; localised swelling; redness; heat; fever; AND the incision is opened deliberately or spontaneously dehisces, 3) there is an abscess within the wound (clinically or radiologically detected).

  4. Full thickness wound dehiscence [ Time Frame: Within 30-days post-intervention ]
    This is defined as all wound layers opening.

  5. Need for re-intervention [ Time Frame: Within 30-days of the primary intervention ]
    Including surgical or percutaneous intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Collaborating centres were recruited using convenience sampling with snowballing. Centres include both tertiary paediatric surgery centres and district hospitals.
Criteria

Inclusion Criteria:

All patients under 16-years of age presenting primarily with one of the five study conditions during the data collection period. This includes those managed conservatively without surgery or intervention and those offered palliative care, except patients with an inguinal hernia who must receive surgery to be included.

Exclusion Criteria:

Patients re-presenting with one of the five study conditions with a complication from a previous intervention or requiring further surgical intervention.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185637


Locations
United Kingdom
King's Centre for Global Health and Health Partnerships
Denmark Hill, London, United Kingdom, SE5 9RJ
Sponsors and Collaborators
King's College London
Sylvanus Olympio University Teaching Hospital, Lome, Togo.
Niamey National Hospital, Niger.
Centre Hospitalier Universitaire de la Mère et de l Enfant, Cotonou, Benin.
HEAL Africa Hospital, Goma, Democratic Republic of the Congo.
Centre Hospitalier Universitaire Pédiatrique Charles de Gaulle
University Hospital De Bouaké, Ivory Coast.
Teaching Hospital Treichville, Abidjan, Ivory Coast.
Harare Central Hospital, Zimbabwe.
University Teaching Hospital, Lusaka, Zambia
Mulago Hospital, Uganda
Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.
Mbingo Baptist Hospital, Cameroon.
Tamale Teaching Hospital, Ghana.
Korle-Bu Teaching Hospital, Accra, Ghana
Edna Adan Maternity Hospital, Hargeisa, Somaliland.
Embu Level 5 Hospital, Kenya.
Tenwek Hospital
Soba University Hospital, Khartoum, Sudan.
Kamuzu Central Hospital, Lilongwe, Malawi
Queen Elizabeth Central Hospital, Blantyre, Malawi
Muhimbili National Hospital, Dar es Salaam, Tanzania.
Grey's Hospital
Stranger Hospital, Kwazulu-Natal, South Africa.
Tygerberg Hospital, South Africa.
Clinton Hospital, Johannesburg
Charlotte Maxeke Johannesburg Academic Hospital
Chris Hani Baragwanath Academic Hospital
East London Hospital Complex, South Africa.
Red Cross War Memorial Childrens Hospital
Delta State University Teaching Hospital Ogharra
Bowen University Teaching Hospital, Ogbomoso
Ondo State Trauma and Surgical Centre
Mnamdi Azikiwe University Teaching Hospital
University Of Nigeria Teaching Hospital
University of Port Harcourt Teaching Hospital
University College Hospital, Ibadan
Ahmadu Bello University Teaching Hospital
University of Abuja Teaching Hospital
National Hospital, Abuja
University of Calabar Teaching Hospital
Federal Medical Centre, Abeokuta
Federal Medical Centre, Owo
Benue State University Teaching Hospital
Olabisi Onabanjo University Teaching Hospital
University of Ilorin Teaching Hospital
Federal Medical Centre Lokoja
Lagos University Teaching Hospital
Lagos State University Teaching Hospital
Obafemi Awolowo University Teaching Hospital
Aminu Kano Teaching Hospital

Publications:

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03185637     History of Changes
Other Study ID Numbers: PSA2016/7
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Following publication, the full anonymous data set will be made publicly available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King's College London:
Outcomes
Mortality
Complications
Neonatal surgery
Paediatric surgery
Childrens surgery
Sub-Saharan Africa
Research Collaboration
Gastroschisis
Anorectal malformation
Appendicitis
Intussuception
Inguinal hernia

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Congenital Abnormalities
Appendicitis
Gastroschisis
Intussusception
Anorectal Malformations
Pathological Conditions, Anatomical
Hernia, Abdominal
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Intestinal Obstruction
Digestive System Abnormalities