Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

University of Pretoria (UP)

Status: Completed

Conditions: Ruptured Ectopic Pregnancy

Treatments: Procedure: Laparoscopy arm; Procedure: Laparotomy arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01932957

Ectopic Trial

Details and patient eligibility

About

Standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. This trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced

The hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain

Full description

Laparoscopic surgery for the surgical management of women diagnosed with ectopic pregnancies has become the standard of care in many institutions around the world. Laparotomy is still the standard of care at Kalafong Hospital. There is very little high quality evidence with regard to the optimal surgical management approach for women with ruptured ectopic pregnancies.

The study aims to compare laparotomy with laparoscopy in this group of women with regards to outcomes such as length of hospital stay, number of days off work and pain.

This randomised study will be conducted at Kalafong hospital, on 140 patients diagnosed with ruptured ectopic pregnancy who are haemodynamically stable and are able and willing to provide informed consent.

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years
• Able to give informed consent
• must have two of the following three:
• systolic blood pressure >90 mmHg
• pulse rate <100 beats per minute
• heamoglobin >8 g/dL

Exclusion criteria

• <18 years
• haemodynamically unstable
• not able to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Laparotomy arm

Other group

Description:

Standard treatment

Treatment:

Procedure: Laparotomy arm

Laparoscopy arm

Experimental group

Description:

Treatment by laparoscopy

Treatment:

Procedure: Laparoscopy arm