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
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
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
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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