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.: PACTR202401560484906 Date of Approval: 16/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Outcomes of Vaginal Hysterectomy With Deschamps Needle Technique Versus Conventional Technique In Women With Non-descent Uterus.
Official scientific title Outcomes of Vaginal Hysterectomy With Deschamps Needle Technique Versus Conventional Technique In Women With Non-descent Uterus.
Brief summary describing the background and objectives of the trial Vaginal surgery in the absence of uterine descent may not be easy. Placing conventional sutures on vascular pedicles deep in the pelvis can be challenging, particularly with the limited vaginal access. So the study aim to compare the feasibility, safety and efficacy of using Deschamps needle technique versus conventional technique in vaginal hysterectomyWith Non-descent Uterus and to determine the operative, intraoperative and postoperative outcomes of both procedures.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date 01/12/2023
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group deschamps needle clampless technique no dose 1-2 hours 1. Vaginal walls are incised by monopolar current (30–35 W). 2. A Deschamps blunt needle is used throughout to hook, stretch and retract all the lateral attachments of uterus (uterosacral-mackenrodt’s-round ligaments) and vessels (uterine arteries) from their posterior aspects; tissues are cut medial to the knots using forceps or monopolar current. 3. Infundibulopelvic ligament will be secured and divided by free technique( passing needle around then ligation and division). 4. Ensuring hemostasis and closure of the vaginal vault. 25
Control Group conventional clamping technique no 1-2 hours 1. Vaginal walls are incised by monopolar current (30–35 W). 2. A right angle clamp is used throughout to elevate, hook, stretch, spread and retract all the lateral attachments of uterus (uterosacral-mackenrodt’s-round ligaments) and vessels (uterine arteries) from their posterior aspects; tissues are dissected and retracted laterally after using surgical knot technique and then are cut medial to the knots using forceps or monopolar current. 3. Conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space for right angle clamp and scissors, and to overcome possible adhesions in previous pelvic surgrey. 4. Ensuring hemostasis and closure of the vaginal vault. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age from 40 years to 70 years. 2. Uterine size less than 12 weeks. 3. Presence of benign cause for the hysterectomy e.g. fibroid uterus, perimenopausal bleeding not responding to medical treatment or complex endometrial hyperplasia without atypia. 4. Absence of significant scarring in the pelvis from previous surgeries. 5- Absence of uterine descent. 1. Suspected or known gynaecological malignancy. 2. Uterine size more than 12 weeks. 3. Endometriosis. 4. Presence of adnexal mass. 5. Cervix flushed with the vagina.ie: thinned out cervix. 6. Presence of significant scarring or severe endometriosis in the pelvic area. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 26/02/2022 Scientific Research Ethics Committee ASU
Ethics Committee Address
Street address City Postal code Country
38 abbassia street - cairo - egypt CAIRO 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Operative time (both total and pedicle securing time). 1- total securing time 2- pedicle securing time
Secondary Outcome  Intraoperative blood loss.  Intraoperative complications including need for blood transfusion, need for laparotomy, and bowel or bladder injury.  Postoperative pain.  Postoperative hospital stay.  Postoperative surgical site infection.  Hospital costs. intra operative and postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Ain Shams University 38 abbasyia square next to el noor mosque cairo 222 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine ain shams university 38 abbassia street next to el noor hospital cairo 1181 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mortada El Sayed Ahmed el tagamoa el awal cairo 1181 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
mohamed soliman hussein soliman selim el awal cairo 1181 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mustafa mohamed abbas mostafaabbas225@gmail.com 00201012201482 el rehab
City Postal code Country Position/Affiliation
cairo 1181 Ecuador lecturer
Role Name Email Phone Street address
Public Enquiries Mortada El Sayed Ahmed dr.mortada.sayed1977@gmail.com 00201001267054 el tagamooa
City Postal code Country Position/Affiliation
cairo 1181 Egypt assisstant professor
Role Name Email Phone Street address
Scientific Enquiries Walid Mohammed dr.walid.basuony@gmail.com 00201001763042 el tagamoaa
City Postal code Country Position/Affiliation
cairo 1181 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial after deidentification. Statistical Analysis Plan following publication Any purpose
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