Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-02

Study Completion Date

2013-11-30

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

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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.

Conditions

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Ruptured Ectopic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparotomy arm

Standard treatment

Group Type OTHER

Laparotomy arm

Intervention Type PROCEDURE

Laparotomy as standard treatment for ruptured ectopic pregnancy

Laparoscopy arm

Treatment by laparoscopy

Group Type EXPERIMENTAL

Laparoscopy arm

Intervention Type PROCEDURE

Laparoscopy as treatment for ruptured ectopic pregnancy

Interventions

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Laparotomy arm

Laparotomy as standard treatment for ruptured ectopic pregnancy

Intervention Type PROCEDURE

Laparoscopy arm

Laparoscopy as treatment for ruptured ectopic pregnancy

Intervention Type PROCEDURE

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