Clinical Trial: Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: University of Pretoria

Current Primary Outcome: Hospital stay [ Time Frame: 5 days ]

Hospital stay will be compared between the two groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain scores [ Time Frame: 24 hours ]
    Pain scores b means of visual analog pain scale
  • Theatre time [ Time Frame: 1 day ]
    Theatre times will be measured and compared for the two groups


Original Secondary Outcome: Same as current

Information By: University of Pretoria

Dates:
Date Received: August 27, 2013
Date Started: May 2012
Date Completion: November 2013
Last Updated: August 27, 2013
Last Verified: August 2013