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

NCT05890066 | Unknown

• 1 other identifier: 5863
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ectopic Pregnancy

Keywords

Laparoscopic surgery; Single-port laparoscope; Multi-port laparoscope

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain intensity

  Within 4 weeks post surgery

• Surgical complications

  Within 4 weeks post surgery

• Hospital stay

  Within 4 weeks post surgery

Study Arms (2)

4-port laparoscopic surgery

NO INTERVENTION

Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery

1-port laparoscopic surgery

EXPERIMENTAL

Patients with ectopic pregnancy will receive 1-port laparoscopic surgery

Procedure: single-port laparoscopy

Interventions

single-port laparoscopy PROCEDURE

Compare the effectiveness and safety between single-port and multi-port laparoscopic surgery

1-port laparoscopic surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The investigators only recruit patients with ectopic pregnancy to participate in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hung Vuong Hospital: lead

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nghiem X Huynh, Doctor

  Hung Vuong Hospital

  STUDY DIRECTOR

Central Study Contacts

Tri B Nguyen, Doctor

CONTACT

0983739959; ngoc.lam@ttu.edu.vn

NGOC T LAM, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 6, 2023
• Study Start: November 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share