Laparoscopic Versus Transvaginal Cuff Closure
Comparison Between Laparoscopic Versus Transvaginal Cuff Closure After Total Laparoscopic Hysterectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
It is still debatable whether that the transvaginal approach to vault closure or laparoscopic suturing are associated with lower risks of vaginal cuff complications . This study aims to compare the two approaches of closure of the vaginal cuff at the end of total laparoscopic hysterectomy as regards the vaginal cuff complications .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2019
CompletedDecember 30, 2021
December 1, 2021
1.1 years
March 21, 2019
December 10, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
1. number of cases ofVaginal cuff dehiscence
Any separation at the level of the vaginal vault.
3 months
Secondary Outcomes (2)
number of cases with vaginal hematoma
3 months
number of cases with vaginal infection
3 months
Study Arms (2)
laparoscopical l cuff closure
ACTIVE COMPARATORneedle holder laparoscopic vaginal cuff closure
transvaginal cuff closure
ACTIVE COMPARATORtransvaginal cuff closure
Interventions
closure of vaginal cuff following hysterectomy
Eligibility Criteria
You may qualify if:
- Patients candidate for total laparoscopic hysterectomy :
- Uterine size \<12 weeks.
- Having no severe endometriosis.
- Having descent of no more than 1st degree of uterus.
- Non-malignant conditions.
- Completion of the entire procedure by laparoscopic approach up to colpotomy.
- Benign conditions as indications for hysterectomy.
You may not qualify if:
- \- 1) Obese patients i.e., BMI \> 30 k.g\\m2. 2) Suspected extensive pelvic adhesions . 3) Factors which may prolong wound healing as uncontrolled diabetes, ,prolonged corticosteroid therapy ,advanced liver diseases.
- \) Inability to express adequate informed consent to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams university
Cairo, 11111, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- neither the paticipant nor the investigator knew type of vaginal cuff closure
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant lecturer
Study Record Dates
First Submitted
March 21, 2019
First Posted
April 2, 2019
Study Start
March 27, 2018
Primary Completion
April 19, 2019
Study Completion
May 16, 2019
Last Updated
December 30, 2021
Record last verified: 2021-12