Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Pretoria
Sponsor:
Information provided by (Responsible Party):
Leon Snyman, University of Pretoria
ClinicalTrials.gov Identifier:
NCT01932957
First received: August 27, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Ruptured Ectopic Pregnancy
Procedure: Laparotomy arm
Procedure: Laparoscopy arm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY

Resource links provided by NLM:


Further study details as provided by University of Pretoria:

Primary Outcome Measures:
  • Hospital stay [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Hospital stay will be compared between the two groups


Secondary Outcome Measures:
  • Pain scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain scores b means of visual analog pain scale

  • Theatre time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Theatre times will be measured and compared for the two groups


Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932957

Contacts
Contact: Leon C Snyman, MBChB FCOG +27834621818 leon.snyman@up.ac.za
Contact: Takalani Makalani, MBChB +27829443668 tmakulana@yahoo.com

Locations
South Africa
Kalafong Academic Hospital Recruiting
Pretoria, Gauteng, South Africa, 0001
Contact: Leon C Snyman, MBChB, MPraxMed, MMed(O&G)    +27834621818    leon.snyman@up.ac.za   
Principal Investigator: Leon C Snyman, MBChB, MPraxMed, MMed, FCOG         
Sub-Investigator: Takalani Makulana, MBChB         
Sponsors and Collaborators
University of Pretoria
Investigators
Principal Investigator: Leon C Snyman, MBChB FCOG Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria
  More Information

No publications provided

Responsible Party: Leon Snyman, Professor, University of Pretoria
ClinicalTrials.gov Identifier: NCT01932957     History of Changes
Other Study ID Numbers: Ectopic Trial
Study First Received: August 27, 2013
Last Updated: August 27, 2013
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Pretoria:
Laparoscopy
Ruptured ectopic pregnancy

Additional relevant MeSH terms:
Cardiac Complexes, Premature
Rupture
Pregnancy, Ectopic
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Wounds and Injuries
Pregnancy Complications

ClinicalTrials.gov processed this record on September 22, 2014