- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06875518
Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Damietta
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Damietta, New Damietta, Egypt, 34518
- Mostafa Bahaa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 35-60 years Patients presented with menometrorrhagia unresponsive to medical treatment, and uterine pathology such as adenomyosis or multiple fibroids.
Exclusion Criteria:
- Patients were excluded if they had: medical conditions preventing pneumo-peritoneum
- Patients with medical conditions hindering proper ventilation during general anesthesia.
- Patients diagnosed with endometrial carcinoma and patients with uterine size larger than 24 weeks were excluded.
- Patients with excessive adhesions precluding access to the uterine arteries were not enrolled in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Group 1 (BTLH with bilateral uterine artery ligation from its origin): The round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied.
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The round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied.
Further incision is then made in the peritoneum.
The bladder fold is pulled downward by opening the anterior leaf of the wide ligament.
It shows the ureters lateralized and the posterior leaf of the wide ligament.
After that, the ureters' path is shown, the retroperitoneal area is revealed, and the location where the uterine artery leaves the iliac artery is seen.
|
|
Active Comparator: Conventional TLH
The conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles.
Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients.
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The conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles.
Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients.
Antibiotic prophylaxis with 3rd generation cephalosporin and metronidazole was given one hour preoperatively.
Obese patients received subcutaneous low molecular weight heparin and compression devices after surgery.
Under general anesthesia, patients were placed in a Lloyd Davis position.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intra operative blood loss
Time Frame: 24 hours
|
Vaginal vault is identified and cut laparoscopically using monopolar hook over the manipulator cup and bipolar grasper for hemostasis until the specimen is detached completely. The uterus with cervix is delivered vaginally. The vaginal vault is sutured laparoscopically with number 1 delayed absorbable suture (Polyglactin; vicryl). The total blood loss is calculated from the suction apparatus. |
24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8749
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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