Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT01932957
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2013-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy
Sponsor:
University of Pretoria
Organization:
Study Overview
Official Title:
A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: