Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201903591178107 Date of Approval: 13/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A modified open omental plugging of peptic ulcer perforation in a mission hospital, Northwestern Cameroon
Official scientific title A modified open omental plugging of peptic ulcer perforation in a mission hospital, Northwestern Cameroon
Brief summary describing the background and objectives of the trial Acute perforated peptic ulcer (PPU) is one of the commonest indications of emergency surgical admissions globally and accounts for more than 70% of deaths associated with peptic ulcer disease (PUD) [1,2]. Gastro-duodenal perforations vary in pattern from one geographical area to another [1, 3, 4]. Bekele et al reported that duodenal perforations were more common than gastric perforations in Ethiopia and that PPU were more common in the youth (mean age of 33.4 years) [1, 3, 4]. In another report by Dongo et al in Nigeria reported that PPU were more commonly seen in gastric ulcers and often affected an older population (mean age of 49.99 years) [3-5]. Historically, the first clinical description of a perforated peptic ulcer was on an autopsy done on the body of King Charles daughter, Henriette Anne, who died suddenly in 1670 Firstly, there is need to evaluate the patient to determine suitability for surgery or consider for conservative treatment instead. Then the critical decision when surgery is indicated; is to consider whether simple closure with or without omentoplasty is sufficient. In recent time, the operation can be performed laparoscopically and there are risk factors that could make laparotomy a safer option [19, 38, 39]. The definitive operation for PPU is performed by few surgeons. Delay in diagnosis and initiation of surgical treatment of PPU has been reported to be associated with high morbidity and mortality postoperatively [12, 22, 32, 40]. The study becomes very paramount because there has not been any of such published reports on the surgical management of PPU in our local environment despite increase in the number of admissions of this condition. This study therefore brings to the fore the patterns of presentation and methods of management of PPU as well as the outcome, in a rural community, Northwestern Cameroon.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PPU
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 11/03/2019
Actual trial start date 01/04/2019
Anticipated date of last follow up 01/05/2019
Actual Last follow-up date 31/05/2019
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL https://www.elsevier.com/wps/find/journaldescription.cws_home/705107?generatepdf
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group nonoperative care of perforated peptic ulcer Non-dose dependent Peri-operative period lasting two weeks no surgery but Nil by mouth, Nasogastric intubation, Intravenous fluids, Intravenous antibiotics 40 Active-Treatment of Control Group
Experimental Group Closure of perforation group Non-dose dependent Two-weeks post operatively Pre-operatively, the patients were resuscitated with intravenous fluids and had baseline biochemical and hematological investigations done. Erect and chest or lateral decubitus radiographs and abdominal ultrasound scan were carried out. Computerized tomographic (CT) scan was unavailable here during the study period. All patients were catheterized and had nasogastric suction. Surgery was performed via a midline supraumbilical incision after adequate resuscitation. Simple closure or omentoplasty was carried out with copious saline peritoneal lavage. The ulcer edge was excised for histology routinely. A drain was usually left in Morrison’s pouch which was routinely removed on the seventh post-operative days. All patients received triple regime antibiotics for 14 days for H. pylori eradication. In addition, number of days spent in the post-operative period before discharge and occurrence of any post-operative complications were also reviewed 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study population consists of all patients admitted with intra-operative diagnosis of perforated peptic ulcer i. All the other causes of peritonitis such as ruptured appendix, traumatic perforations, tuberculosis enteric perforations, e.t.c, were excluded from the study. ii. All patients with suspected peritonitis due to perforated peptic ulcer disease for whom a laparotomy was not performed. iii. All patients whose case file did not contain follow-up data. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/12/2018 Caritas Foundation Healthcare Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
No 55, Mbveh Road, Kumbo-Nso Kumbo -Nso 12244 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome sealed perforation one weeks post operatively
Secondary Outcome Development of complications - wound infection, intraabdominal abscess, wound dehiscence, incisional hernia 3month -6months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St Elizabeth Catholic General Hospital No 1 Hospital Road, Shisong Kumbo Nso 123456 Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Bamidele Alegbeleye No 1, Hospital Road Shisong Kumbo Nso 123456 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor NOT APPLICABLE NOT APPLICABLE NOT APPLICABLE 12456 Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Frederick Tatah Kiven N0 1, Hospital Road Shishong KUMBO NSO 123456 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bamidele Alegbeleye drbalegbeleye@gmail.com +237670628857 No 1 Hospital Road Shisong
City Postal code Country Position/Affiliation
Kumbo Nso 123456 Cameroon Consultant General Surgeon St Elizabeth Catholic General Hospital
Role Name Email Phone Street address
Public Enquiries Oluwayemisi Alegbeleye alegbeleyeoluwayemisi@gmail.com +237681002906 No 1, Hospital Road Shisong
City Postal code Country Position/Affiliation
Kumbo Nso 123456 Cameroon IDD Reseach Staff St Elizabeth Catholic General Hospital
Role Name Email Phone Street address
Scientific Enquiries Paul Kobinux kobinux1970@gmail.com +2348060405759 No. 54, Mbveh Road
City Postal code Country Position/Affiliation
Kumbo Nso 123456 Cameroon Professor Surgery Liberal College Ondo State Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data gathered during the trial after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan Immediately after publication, no end date in sight Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data to be available at link to be included No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information