Surgical Outcomes of Conventional Hysterectomy or Manipulator-assisted Abdominal Hysterectomy

NCT06374940 | Enrolling By Invitation DMC

• 1 other identifier: Lütfi Kırdar City Hospital
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gynecologic Disease

Keywords

Hysterectomy, Manipulator-assisted abdominal hysterectomy

Outcome Measures

Primary Outcomes (1)

• Duration of the surgical procedure

  The surgical operative time was defined as the time from incision to completion of wound closure, also known as 'cut-to-close' time. In the manipulator-assisted abdominal hysterectomy group, the time of uterine manipulator placement was added to the operation time

  intraoperative

Secondary Outcomes (4)

• Postoperative pain at 6th hours

  At the 6th hours after the surgical procedure

• Postoperative pain at 24th hours

  At the 24th hours after the surgical procedure

• intraoperative complications

  Intraoperative

• Postoperative complications

  Postoperative, in the first month of the surgery

Study Arms (2)

conventional abdominal hysterectomy

NO INTERVENTION

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

Manipulator-assisted Abdominal Hysterectomy

OTHER

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.

Procedure: Manipulator-assisted Abdominal Hysterectomy

Interventions

Manipulator-assisted Abdominal Hysterectomy PROCEDURE

Manipulator-assisted Abdominal Hysterectomy

Manipulator-assisted Abdominal Hysterectomy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Dr.Lütfi Kırdar City Hospital

Istanbul, 34000, Turkey (Türkiye)

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of obstetrics and gynecology

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 17, 2024
• Primary Completion: May 17, 2024
• Study Completion: May 18, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon request, after the work is published, 5 years
• Access Criteria: Upon request, after the work is published, 5 years

Locations

TU (1)