NCT01932957

Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: University of Pretoria · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ruptured Ectopic Pregnancy

Interventions

Type	Name	Description
PROCEDURE	Laparotomy arm	Laparotomy as standard treatment for ruptured ectopic pregnancy
PROCEDURE	Laparoscopy arm	Laparoscopy as treatment for ruptured ectopic pregnancy

Timeline

• Start date: 2012-05-02
• Primary completion: 2013-10-31
• Completion: 2013-11-30
• First posted: 2013-08-30
• Last updated: 2021-03-11

Locations

1 site across 1 country: South Africa