Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ruptured Ectopic Pregnancy

Intervention / Treatment
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* Procedure: Laparotomy arm
* Procedure: Laparoscopy arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laparotomy arm<br>Standard treatment | Procedure: Laparotomy arm<br>* Laparotomy as standard treatment for ruptured ectopic pregnancy<br>|
| Experimental: Laparoscopy arm<br>Treatment by laparoscopy | Procedure: Laparoscopy arm<br>* Laparoscopy as treatment for ruptured ectopic pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Hospital stay will be compared between the two groups | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Pain scores b means of visual analog pain scale | 24 hours | 
| Theatre time | Theatre times will be measured and compared for the two groups | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Ruptured ectopic pregnancy