Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy

June 5, 2023 updated by: Tri Bao Nguyen, Hung Vuong Hospital

Effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy

This study aims to compare the effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Single-port laparoscopic surgery has become one of the treatment options for ectopic pregnancy with certain advantages such as reduced numbers of incision and scars, and increased patient's satisfaction post-surgery. At Hung Vuong hospital, the investigators do not have data about the application potential of single-port laparoscopic surgery for ectopic pregnancy treatment. Therefore, the investigators carry out this project to compare the effectiveness and safety of single-port versus traditional multi-port laparoscopic surgery in the treatment of ectopic pregnancy.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: NGOC T LAM, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old or older pregnant women who are indicated for laparoscopic surgery in the treatment of ectopic pregnancy.
  • Agree to participate and give a consent

Exclusion Criteria:

  • Allergic reactions to anesthetics
  • Hemodynamic instability
  • Ruptured ectopic pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 4-port laparoscopic surgery
Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery
Experimental: 1-port laparoscopic surgery
Patients with ectopic pregnancy will receive 1-port laparoscopic surgery
Procedure: single-port laparoscopy
Compare the effectiveness and safety between single-port and multi-port laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Immediately post surgery
Measure the amount of blood loss
Immediately post surgery
Surgical time
Time Frame: Immediately post surgery
How long will it take for single-port vs multi-port surgical procedures
Immediately post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Within 4 weeks post surgery
Use visual analogue scale to measure
Within 4 weeks post surgery
Surgical complications
Time Frame: Within 4 weeks post surgery
Organ damages, surgical site infections, pneumoperitoneum
Within 4 weeks post surgery
Hospital stay
Time Frame: Within 4 weeks post surgery
How long will be the recovery time
Within 4 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hung Vuong Hospital

Investigators

  • Study Director: Nghiem X Huynh, Doctor, Hung Vuong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5863 (Other Identifier: Project ID - Ethical Committee UZA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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