Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy

Republic of Turkey Ministry of Health

Status: Invitation-only

Conditions: Gynecologic Disease

Treatments: Procedure: Manipulator-assisted Abdominal Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06374940

Lütfi Kırdar City Hospital

Details and patient eligibility

About

Objective: The comparison of surgical outcomes conventional hysterectomy and manipulator-assisted hysterectomy

Study design: Prospective randomized controlled trial. Allocation to either group occurred via computer-generated random numbers. Sequentially numbered, opaque envelopes were prepared according to randomization. The patients were unaware of whether they would undergo a conventional hysterectomy or manipulator-assisted abdominal hysterectomy for their surgical procedure. The research coordinator unveiled group assignments upon individual patient recruitment by opening the corresponding envelope.

Study population: Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications.

Primary outcomes: (1) Operation Time.

Secondary outcomes: (1) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery) (2) intraoperative complications, (3) postoperative complications

Enrollment: 140 estimated patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria were patients aged 40-70 years who underwent hysterectomy for benign gynecological indications

Exclusion criteria

• Exclusion criteria were patients with additional procedures such as urogynecologic procedures, history of abdominal surgery with midline incision, patients with suspected gynecologic malignancy, endometriosis, tubo-ovarian abscess, pelvic organ prolapse, or those who refused to participate in the study and whose medical records could not be obtained.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

conventional abdominal hysterectomy

No Intervention group

Description:

The surgical technique of conventional abdominal hysterectomy was described in the literature.

Manipulator-assisted Abdominal Hysterectomy

Other group

Description:

In manipulator-assisted abdominal hysterectomy tecnique, a uterine manipulator (SecuFix ® , Richard Wolf) was inserted into the cervix. Conventional hysterectomy steps were performed until the vaginal colpotomy incision. A circular colpotomy incision was made directly over the manipulator silicone cup using a monopolar cautery set at 30W cutting mode without interfering with the cardinal ligament or sacrouterine ligament. The vaginal cuff was sutured using polyglactin 910 (no:1) as a single layer running suture.

Treatment:

Procedure: Manipulator-assisted Abdominal Hysterectomy