Laparascopy Versus Laparatomy in the Management of Ruptur... | NCT01932957

Studies
Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

NCT01932957

Sponsor

University of Pretoria

Status

Completed

Last Update Posted

Mar 11, 2021Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Ruptured Ectopic Pregnancy

Interventions

Laparotomy arm
Laparoscopy arm

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2012Actual

Primary Completion Date

Oct 31, 2013Actual

Completion Date

Nov 30, 2013Actual

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Aug 27, 2013

First Posted Date

Aug 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2021

Last Update Posted Date

Mar 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leon Snyman, Professor, University of PretoriaPrincipal Investigator

Lead Sponsor

University of PretoriaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Laparotomy arm	Other	Standard treatment	Procedure: Laparotomy arm
Laparoscopy arm	Experimental	Treatment by laparoscopy	Procedure: Laparoscopy arm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparotomy arm	Procedure	Laparotomy as standard treatment for ruptured ectopic pregnancy	Laparotomy arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leon C Snyman, MBChB FCOG	Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kalafong Academic Hospital		Pretoria	Gauteng	0001	South Africa