Total Laparoscopic Hysterectomy vs Minilap Hysterectomy

A Prospective Randomized Study Comparing Total Laparoscopic Hysterectomy (Lap Hysterectomy) vs Minilaparotomy (Mini-lap Hysterectomy) for Benign Uterine Lesions: Peri-operative Outcome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03251677

Enrollment

Registered

2017-08-16

Start date

2017-09-01

Completion date

2019-03-01

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteromyoma

Brief summary

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

Detailed 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.

Interventions

PROCEDURESurgical procedure, Hysterectomy

Surgical removal of the uterus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Operative Time (min)	Intraoperative (Starting with induction of anesthesia (Time 0) up to complete removal of the uterus)	Time in minutes taken for total hysterectomy
Estimated blood loss (mL)	Through surgical intervention completion	Drop of hemoglobin and hematocrit percentage (%) 24-hours from basal pre-operative values

Secondary

Measure	Time frame	Description
Early postoperative complications	Within 30 days after operation	Related complications

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026