Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

Ruptured Ectopic Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932957
• Other study ID #: Ectopic Trial
• Status: Completed
• Phase: N/A
• Start date: May 2, 2012
• Est. completion date: November 30, 2013

Study information

• Verified date: March 2021
• Source: University of Pretoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 30, 2013
• Est. primary completion date: October 31, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, Ectopic
• Rupture
• Ruptured Ectopic Pregnancy

Intervention

Procedure:
• Laparotomy arm
Laparotomy as standard treatment for ruptured ectopic pregnancy
• Laparoscopy arm
Laparoscopy as treatment for ruptured ectopic pregnancy

Locations

Country	Name	City	State
South Africa	Kalafong Academic Hospital	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Pretoria

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital stay	Hospital stay will be compared between the two groups	5 days
Secondary	Pain scores	Pain scores b means of visual analog pain scale	24 hours
Secondary	Theatre time	Theatre times will be measured and compared for the two groups	1 day