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

NCT ID: NCT05890066

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Ectopic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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4-port laparoscopic surgery

Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

1-port laparoscopic surgery

Patients with ectopic pregnancy will receive 1-port laparoscopic surgery

Group Type EXPERIMENTAL

single-port laparoscopy

Intervention Type PROCEDURE

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

Interventions

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single-port laparoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hung Vuong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tri Bao Nguyen

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nghiem X Huynh, Doctor

Role: STUDY_DIRECTOR

Hung Vuong Hospital

Central Contacts

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Tri B Nguyen, Doctor

Role: CONTACT

0983739959

NGOC T LAM, PhD

Role: CONTACT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5863

Identifier Type: -

Identifier Source: org_study_id

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