Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

Mansoura University

Status: Completed

Conditions: Hysteromyoma

Treatments: Procedure: Surgical procedure, Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03251677

MD/16.12.51

Details and patient eligibility

About

The objective of this study is to compare the perioperative outcomes between mini-lap hysterectomy and total laparoscopic hysterectomy (TLH) because of benign indications.

Full description

A prospective randomized open-label study was conducted. Women >18 years of age undergoing TLH because of benign indications were recruited. Patients were randomized for either TLH (Group I, 40 cases) or minilap hysterectomy (Group II, 40 cases) through 4-5cm abdominal Pfannenstiel incision.

Inclusion criteria were mobile uterus with benign lesion and with a size up to 12 weeks gestation. Exclusion criteria adopted were patients with enlarged uterus < 12 weeks, suspected malignancy and large adnexal masses (>5cm). Peri-operative outcomes were compared.

Written informed consent was obtained from all the patients and the Departmental Ethical Committee approved the study. Patients from OB/GYN Mansoura University Hospital were enrolled. All the operations were performed by at least one of the consultants included as authors in this study.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mobile uterus.
• Uterine size up to 12 weeks gestation.
• Benign lesions.

Exclusion criteria

• Enlarged uterus > 12 weeks gestation.
• Suspected malignancy.
• Large adnexal masses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Total laparo hysterectomy

Active Comparator group

Description:

Surgical procedure, Hysterectomy (removal of the uterus by laparoscopy)

Treatment:

Procedure: Surgical procedure, Hysterectomy

Mini-lap hysterectomy

Active Comparator group

Description:

Surgical procedure, Hysterectomy (removal of the uterus by mini-laparotomy)

Treatment:

Procedure: Surgical procedure, Hysterectomy