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.: PACTR202106887906354 Date of Registration: 23/06/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Uterine Incision Compression for abdominal myomectomy
Official scientific title Adjunctive Uterine Incision compression versus tourniquet alone for reduction of blood loss during abdominal myomectomy; a randomized controlled trial
Brief summary describing the background and objectives of the trial Background: Myomectomy is a fertility preserving surgery which is useful in preparing the uterus for both spontaneous and assisted conception. Myomectomy is the standard uterus-sparing treatment for uterine fibroids. The more complex myomectomies today are done through the abdominal route. This procedure is however fraught with life-threatening perioperative haemorrhage, which could be a trigger for all the other complications of myomectomy. There is presently no consensus on the best method to reduce haemorrhage during myomectomy. Uterine artery tourniquet has been used for a long time, with conflicting reports about its effectiveness alone for haemostasis during myomectomy. Objectives: To determine the effect of uterine incision compression combined with uterine tourniquet placement on the operative blood loss associated with abdominal myomectomy. Methods: A multi-centre randomized double blind controlled trial, which would involve 240 women aged 18-45 years, undergoing abdominal myomectomy, 120 women each in the intervention and the control groups respectively. The intervention consists of bimanual uterine incision compression, in the interval from the release of the uterine catheter tourniquet to the palpation of uterine contraction. The operative blood loss, rate of placement of abdominal drains, postoperative febrile morbidity and the duration of hospital stay would be compared between the 2 groups. Results: Data would be analyzed using the Software package for social sciences (SPSS), version 21. Frequency tables would be drawn and numerical data expressed as mean ± standard deviation. Univariate analysis would be done; expressing frequencies as means and standard deviations while for bivariate analysis, categorical variables would be compared using the Chi-square test or the Fisher exact test where applicable. Continuous variables would be compared using the student t-test and the 2-tailed significance values would be taken.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) UIC fibroid
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2021
Actual trial start date 08/03/2021
Anticipated date of last follow up 15/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://scholar.google.com/citations?user=S_DxVMcAAAAJ&hl=en&authuser=1
Secondary Ids Issuing authority/Trial register
BUHREC00221 Babcock University Health Research Ethics Committee
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bimanual Uterine Incision Compression The uterus would be covered with an abdominal towel and grasped between the two hands of the surgeon such that the incisions (all incisions) are compressed as soon as the uterine haemostatic tourniquet is released. The pressure on the incisions would be maintained until uterine re-perfusion (as evidenced by occurrence of uterine contractions) is achieved, by palpating contractions around the incisions; before the compressing hands are removed. This is defined as the bimanual compression of all the uterine incision(s), together after completion of closure of dead spaces and release of uterine tourniquet, clips, sutures or clamps placed to reduce blood flow and prevent haemorrhage during myomectomy. The uterus would be covered with an abdominal towel and grasped between the two hands of the surgeon such that the incisions (all incisions) are compressed as soon as the uterine haemostatic tourniquet is released. The pressure on the incisions would be maintained until uterine re-perfusion (as evidenced by uterine contractions) is achieved, by palpating contractions around the incisions; before the compressing hands are removed. The uterus is then observed for any more bleeding from the uterine incision sites and other outcome variables assessed. 120
Control Group Routine abdominal myomectomy Routine abdominal myomectomy The other group of participants (control group) would have their usual myomectomy, but without compression of the incision site(s) after release of the uterine haemostatic tourniquets. 120 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients aged 18-45 years, undergoing abdominal myomectomy. Patients with uterine fibroids without adhesive complcations. Patients fibroid undergoing myomectomy for the first time. History of coagulopathy, or heart disease, or myocardial infarction, or hypertension, or diabetes, or sickle cell disease, or kidney disease Pre-operative PCV <30%. Patients with thromboembolic disease, or on anticoagulants' History of allergy to tranexamic acid or vasopressin or ergometrine. History of previous myomectomy or previous extensive pelvic surgery or features suggestive of pelvic adhesions. Patients who would not accept blood transfusion. History or imaging features suspicious of malignancy. Entirely subserosal fibroids or entirely submucous fibroids that do not involve intramural incisions and fibroid enucleation. Laparoscopic, hysteroscopic or combinations of either with abdominal myomectomy. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 45 Year(s) Female
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 27/01/2021 Babcock University Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Babcock University Ilisan-Remo 121103 Nigeria
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 10/02/2021 Federal Medical Centre Abeokuta Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Idi-Aba Abeokuta 110211 Nigeria
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 02/03/2021 Olabisi Onabanjo University Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road Sagamu 121101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is operative blood loss from abdominal myomectomy. The operative blood loss would include itraoperative blood loss, taken from gauzes, sponges, towels and suction bottles and postoperative blood loss
Secondary Outcome Duration of abdominal myomectomy in minutes Interval from abdominal skin incision to abdominal skin closure
Secondary Outcome Postoperative pain Pain scores, from immediate posteoperative period, through two days post-operative to fifth postoperative day.
Secondary Outcome Intraperitoneal drain placement From before abdominal incision closure to when drain becomes inactive
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Babcock University Teaching Hospital Siloam Valley, Babcock University Ilisan Remo 121103 Nigeria
Federal Medical Centre Abeokuta Idi-Aba Abeokuta 110211 Nigeria
Olabisi Onabanjo University Teaching Hospital Sagamu Hospital Road Sagamu 121101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr John Osaigbovoh Imaralu Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital Ilisan Remo 121103 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Babcock University Ilisan-Remo Ilisan Remo 121103 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Loto Olabisi Morebise Department of Obstetrics and Gynaecology, Obafemi Awolowo University Ile Ife 220001 Nigeria
Jagun Olusoji Edward Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital Sagamu 121101 Nigeria
Ogunfunmilayo Taofeek Department of Obstetrics and Gynaecology, Federal Medical Centre Abeokuta 110211 Nigeria
Odusoga Tola Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital Sagamu 121101 Nigeria
Nwankpa Chimaobi Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital Ilisan Remo 121103 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Imaralu imaralujohn@yahoo.co.uk +2348067857419 Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital
City Postal code Country Position/Affiliation
Ilisan Remo 121103 Nigeria Associate Professor and Consultant department of Obstetrics and Gynaecology Babcock University and Babcock University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Chimaobi Nwankpa Nwankpac@babcock.edu.ng +2348068710017 Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital
City Postal code Country Position/Affiliation
Ilisan Remo 121103 Nigeria Senior Registrar and Chief resident Babcock University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Olabisi Loto bisiloto@yahoo.co.uk +2348066546725 Department of Obstetrics and Gynaecology, Obafemi Awolowo University
City Postal code Country Position/Affiliation
Ile Ife 220001 Nigeria Professor and Consultant department of Obstetrics and Gynaecology Obafemi Awolowo University Ile Ife
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol From 12 months after study completion to 3 years of completion Researchers in related study who make requests
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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