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