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

Primary Purpose

Ectopic Pregnancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single-port laparoscopy
Sponsored by
Hung Vuong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectopic Pregnancy focused on measuring Laparoscopic surgery, Single-port laparoscope, Multi-port laparoscope

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    4-port laparoscopic surgery

    1-port laparoscopic surgery

    Arm Description

    Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery

    Patients with ectopic pregnancy will receive 1-port laparoscopic surgery

    Outcomes

    Primary Outcome Measures

    Blood loss
    Measure the amount of blood loss
    Surgical time
    How long will it take for single-port vs multi-port surgical procedures

    Secondary Outcome Measures

    Pain intensity
    Use visual analogue scale to measure
    Surgical complications
    Organ damages, surgical site infections, pneumoperitoneum
    Hospital stay
    How long will be the recovery time

    Full Information

    First Posted
    May 25, 2023
    Last Updated
    June 5, 2023
    Sponsor
    Hung Vuong Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05890066
    Brief Title
    Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy
    Official Title
    Effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    May 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hung Vuong Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ectopic Pregnancy
    Keywords
    Laparoscopic surgery, Single-port laparoscope, Multi-port laparoscope

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    4-port laparoscopic surgery
    Arm Type
    No Intervention
    Arm Description
    Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery
    Arm Title
    1-port laparoscopic surgery
    Arm Type
    Experimental
    Arm Description
    Patients with ectopic pregnancy will receive 1-port laparoscopic surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    single-port laparoscopy
    Intervention Description
    Compare the effectiveness and safety between single-port and multi-port laparoscopic surgery
    Primary Outcome Measure Information:
    Title
    Blood loss
    Description
    Measure the amount of blood loss
    Time Frame
    Immediately post surgery
    Title
    Surgical time
    Description
    How long will it take for single-port vs multi-port surgical procedures
    Time Frame
    Immediately post surgery
    Secondary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Use visual analogue scale to measure
    Time Frame
    Within 4 weeks post surgery
    Title
    Surgical complications
    Description
    Organ damages, surgical site infections, pneumoperitoneum
    Time Frame
    Within 4 weeks post surgery
    Title
    Hospital stay
    Description
    How long will be the recovery time
    Time Frame
    Within 4 weeks post surgery

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    The investigators only recruit patients with ectopic pregnancy to participate in the study
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tri B Nguyen, Doctor
    Phone
    0983739959
    Email
    ngoc.lam@ttu.edu.vn
    First Name & Middle Initial & Last Name or Official Title & Degree
    NGOC T LAM, PhD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nghiem X Huynh, Doctor
    Organizational Affiliation
    Hung Vuong Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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