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

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

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.

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

Conditions
-----------------
Ectopic Pregnancy

Intervention / Treatment
-----------------
* Procedure: single-port laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a parallel-group randomized control trial with 2 arms. Arm 1 includes patients who will be treated by traditional multi-port laparoscopic surgery. Aim 2 includes patients who will be treated by single-port laparoscopic surgery. All patients are randomized using computer-generated sequences with allocation ratio 1:1. This is a non-blinded study where all patients and surgical teams know the treatment option.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | Measure the amount of blood loss | Immediately post surgery | 
| Surgical time | 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 | Use visual analogue scale to measure | Within 4 weeks post surgery | 
| Surgical complications | Organ damages, surgical site infections, pneumoperitoneum | Within 4 weeks post surgery | 
| Hospital stay | How long will be the recovery time | Within 4 weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery, Single-port laparoscope, Multi-port laparoscope