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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01932957

Enrollment

140

Registered

2013-08-30

Start date

2012-05-02

Completion date

2013-11-30

Last updated

2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ruptured Ectopic Pregnancy

Keywords

Laparoscopy, Ruptured 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 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.

Interventions

PROCEDURELaparotomy arm

Laparotomy as standard treatment for ruptured ectopic pregnancy

PROCEDURELaparoscopy arm

Laparoscopy as treatment for ruptured ectopic pregnancy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hospital stay	5 days	Hospital stay will be compared between the two groups

Secondary

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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026