Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.

NCT ID: NCT06875518

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-12
• Study Completion Date: 2025-12-20

Brief Summary

Following Caesarean section, hysterectomy is the second most common major gynecological surgery, with approximately 600,000 procedures performed annually in the USA. Since Reich et al. first reported a total laparoscopic hysterectomy (TLH) in 1989, numerous studies have confirmed its feasibility and reproducibility. Evidence increasingly supports TLH over vaginal hysterectomy (VH) and total abdominal hysterectomy (TAH) for benign gynecological conditions. The development and rapid advancement of laparoscopic instruments and techniques have enabled the safe and successful completion of complex procedures using minimally invasive approaches. Women with a higher BMI or requiring complex surgeries benefit from reduced postoperative complications with laparoscopic operations.

Conditions

Gynecologic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

BTLH with bilateral uterine artery ligation from its origin

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional TLH

Intervention Type: PROCEDURE

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.

Interventions

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. 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.

Intervention Type: PROCEDURE

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. 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mostafa Bahaa

OTHER

Sponsor Role: lead

Responsible Party

Mostafa Bahaa

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mostafa Bahaa

Damietta, New Damietta, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Mostafa Bahaa, PhD

Role: primary

mbahaa@horus.edu.eg

0201025538337

Other Identifiers

8749

Identifier Type: -

Identifier Source: org_study_id