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Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

Primary Purpose

Ruptured Ectopic Pregnancy

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Laparotomy arm
Laparoscopy arm
Sponsored by
University of Pretoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ruptured Ectopic Pregnancy focused on measuring Laparoscopy, Ruptured ectopic pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Kalafong Academic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Laparotomy arm

Laparoscopy arm

Arm Description

Standard treatment

Treatment by laparoscopy

Outcomes

Primary Outcome Measures

Hospital stay
Hospital stay will be compared between the two groups

Secondary Outcome Measures

Pain scores
Pain scores b means of visual analog pain scale
Theatre time
Theatre times will be measured and compared for the two groups

Full Information

First Posted
August 27, 2013
Last Updated
March 8, 2021
Sponsor
University of Pretoria
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1. Study Identification

Unique Protocol Identification Number
NCT01932957
Brief Title
Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy
Official Title
A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2012 (Actual)
Primary Completion Date
October 31, 2013 (Actual)
Study Completion Date
November 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pretoria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ruptured Ectopic Pregnancy
Keywords
Laparoscopy, Ruptured ectopic pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparotomy arm
Arm Type
Other
Arm Description
Standard treatment
Arm Title
Laparoscopy arm
Arm Type
Experimental
Arm Description
Treatment by laparoscopy
Intervention Type
Procedure
Intervention Name(s)
Laparotomy arm
Intervention Description
Laparotomy as standard treatment for ruptured ectopic pregnancy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopy arm
Intervention Description
Laparoscopy as treatment for ruptured ectopic pregnancy
Primary Outcome Measure Information:
Title
Hospital stay
Description
Hospital stay will be compared between the two groups
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Pain scores
Description
Pain scores b means of visual analog pain scale
Time Frame
24 hours
Title
Theatre time
Description
Theatre times will be measured and compared for the two groups
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon C Snyman, MBChB FCOG
Organizational Affiliation
Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalafong Academic Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

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