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.: PACTR202309800116065 Date of Registration: 26/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Laparoscopic versus vaginal approach closure complications
Official scientific title Laparoscopic versus vaginal approach closure complications of vaginal vault in laparoscopic hysterectomy
Brief summary describing the background and objectives of the trial Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally.Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs. So The study shows effects of the laparoscopic method versus the vaginal method for suturing the vaginal vault closure during total laparoscopic hysterectomy on female sexual function. And To compare complications in vaginal vault closure during laparoscopic hysterectomy using the laparoscopic and vaginal methods.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied closure of vaginal vault complications
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2023
Actual trial start date 07/07/2023
Anticipated date of last follow up 15/12/2023
Actual Last follow-up date 30/12/2023
Anticipated target sample size (number of participants) 65
Actual target sample size (number of participants) 56
Recruitment status Recruiting
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group A 3 months patients undergoing vaginal vault closure by vaginal approach 28
Experimental Group Group B 3 Months Female patients undergoing vaginal vault closure by Abdominal laparoscopic approach after Abdominal Laparoscopic Hysterectomy 28
Control Group NA NA NA 0 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients who undergo laparoscopic hysterectomy 2- Age ranged from 40 to 80 years. 3- Patients suffering from chronic pelvic inflammatory disease (PID) 4- Dysfunctional uterine bleeding 5- Adenomyosis 6- Endometriosis 7- Fibroid 8- Endometrial hyperplasia 9- Benign ovarian cyst - Patients with known malignancy Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 80 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 25/03/2023 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Nasr City Nasr City 12311 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post operative bleeding (defined as blood loss ≥500 cc) as Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation. First 24 hours after The Operations
Secondary Outcome Postoperative pain as Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain First 24 hours after The Operations
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Azhar Faculty of Medicine Hospitals Nasr City Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Mohamed Adel Hussien Bab El Shaaria Street Cairo 13111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sayed Galal Bab elshaarya Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Sayed Galal Hospitals Elgeish street Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Adel Hussien elhoseeeeeeny@gmail.com +201065702255 Mansoura
City Postal code Country Position/Affiliation
Mansoura Egypt Resident of Obstetrics and Gynaecology at Mansoura Specialized Hospital
Role Name Email Phone Street address
Scientific Enquiries Ahmed Altaf Abbas ahmedaltf39@gmail.com +201065702255 AlHussein Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor Of Obstetrics And Gynecology. AlAzhar University
Role Name Email Phone Street address
Public Enquiries Elsayed Ahmed Eldesoky elsayedeldesouky@yahoo.com +201092934978 Elgeish street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor Of Obstetrics And Gynecology. AlAzhar University.Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No IPD sharing according to participants request Statistical Analysis Plan,Study Protocol A minimum summary results will be shared within 12 months of the study completion date. Type of study: Prospective observational study Setting: Obstetrics and Gynacology Department at Al-Azhar university hospitals and other private hospitals. Sample size: Sample size calculation was based on incidence of complications between Vault closure route laparoscopic & Vault closure rout vaginal retrived from previous research. Study group : 56 patients undergoing laparoscopic hystercomy . Patients will be divided into 2 groups: Group ( A ) : 28 patients vaginal vault closed by vaginal approach Group ( B ) : 28 patients vaginal vault closed by laparoscopic approach. Methods: 56 women who are candidate for laparoscopic hysterectomy in Al-Azhar University Hospitals and other private Hospitals, Egypt. Patients were selected with the common criteria of benign gynecological disorders for hysterectomy. The indications varied from chronic pelvic inflammatory diseases (PID), dysfunctional uterine bleeding, adenomyosis, endometriosis, fibroid, endometrial hyperplasia, benign ovarian cyst. All women participated in this study signed an informed consent. The same operative and anesthetic techniques were made in all women. All ladies were exposed to the same technique of laparoscopy and same preparation. The technique of approximation of the vault was made either with laparoscopic method or through vaginal method with the use of vicryl 1 to see the difference between the two methods. Laparoscopic approach was done with continuous suturing of the vault with adequate homeostasis. 56 ladies were promptly aware about details of maneuver. Advancement in surgical techniques allows us to enormously reach to the best steps in endoscopy that favors better outcomes for the sake of the ladies who suffered from gynecological abnormalities. All patients of the two groups were scheduled for postoperative Follow up visits for three months after surgery for postoperative complications including postoperative pain, postoperative hospital stay, spotting, haemorrhage, infection of the vault
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