Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

Not Applicable

Completed

• Conditions: Ruptured Ectopic Pregnancy
• Interventions: Procedure: Laparotomy arm; Procedure: Laparoscopy arm

• Registration Number: NCT01932957
• Lead Sponsor: University of Pretoria

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.

Study Timeline

• Study Start: 2012-05-02
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Primary Completion: 2013-10-31
• Study Completion: 2013-11-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparotomy arm	Laparotomy arm	Standard treatment
Laparoscopy arm	Laparoscopy arm	Treatment by laparoscopy

Primary Outcome Measures

Name	Time	Method
Hospital stay	5 days	Hospital stay will be compared between the two groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kalafong Academic Hospital; 🇿🇦 Pretoria, Gauteng, South Africa