Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

March 8, 2021 updated by: Leon Snyman, University of Pretoria

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • Kalafong Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Laparotomy arm
Standard treatment
Procedure: Laparotomy arm
Laparotomy as standard treatment for ruptured ectopic pregnancy
EXPERIMENTAL: Laparoscopy arm
Treatment by laparoscopy
Procedure: Laparoscopy arm
Laparoscopy as treatment for ruptured ectopic pregnancy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pretoria

Investigators

  • Principal Investigator: Leon C Snyman, MBChB FCOG, Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2012

Primary Completion (ACTUAL)

October 31, 2013

Study Completion (ACTUAL)

November 30, 2013

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (ESTIMATE)

August 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ectopic Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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