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

NCT06875518 | Completed

• 1 other identifier: 8749
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intra operative blood loss

  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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

Procedure: BTLH with bilateral uterine artery ligation from its origin

Conventional TLH

ACTIVE COMPARATOR

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.

Procedure: Conventional TLH

Interventions

BTLH with bilateral uterine artery ligation from its origin 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.

Control group

Conventional TLH 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.

Conventional TLH

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 35-60 years Patients presented with menometrorrhagia unresponsive to medical treatment, and uterine pathology such as adenomyosis or multiple fibroids.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mostafa Bahaa: lead

Study Sites (1)

Mostafa Bahaa

Damietta, New Damietta, 34518, Egypt

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: March 12, 2025
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

EG (1)