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Completed

NCT Number: NCT01932957

Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

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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Key information

Conditions

Ruptured Ectopic Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kalafong Academic Hospital

Pretoria, Gauteng, 0001, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparotomy arm

Procedure

Laparotomy as standard treatment for ruptured ectopic pregnancy

Laparoscopy arm

Procedure

Laparoscopy as treatment for ruptured ectopic pregnancy

Primary outcomes

  1. Hospital stay

    Time frame: 5 days

    Hospital stay will be compared between the two groups

Secondary outcomes

  1. Pain scores

    Time frame: 24 hours

    Pain scores b means of visual analog pain scale

  2. Theatre time

    Time frame: 1 day

    Theatre times will be measured and compared for the two groups

Sponsors and collaborators

Lead sponsor

University of Pretoria

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2013
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.