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

• Sponsor: Hung Vuong Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05890066
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ectopic Pregnancy	Procedure: single-port laparoscopy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 4-port laparoscopic surgery Patients with ectopic pregnancy will receive 4-Port laparoscopic surgery
Experimental: 1-port laparoscopic surgery Patients with ectopic pregnancy will receive 1-port laparoscopic surgery	Procedure: single-port laparoscopy; Compare the effectiveness and safety between single-port and multi-port laparoscopic surgery

Outcome Measures

Primary Outcome Measures

1. Blood loss [Immediately post surgery]

   Measure the amount of blood loss

2. Surgical time [Immediately post surgery]

   How long will it take for single-port vs multi-port surgical procedures

Secondary Outcome Measures

1. Pain intensity [Within 4 weeks post surgery]

   Use visual analogue scale to measure

2. Surgical complications [Within 4 weeks post surgery]

   Organ damages, surgical site infections, pneumoperitoneum

3. Hospital stay [Within 4 weeks post surgery]

   How long will be the recovery time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hung Vuong Hospital

Investigators

• Study Director: Nghiem X Huynh, Doctor, Hung Vuong Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 28, 2023

More Information

Publications

None provided.

• Responsible Party: Tri Bao Nguyen, Principle investigator, Hung Vuong Hospital
• ClinicalTrials.gov Identifier: NCT05890066
• Other Study ID Numbers: 5863
• First Posted: Jun 6, 2023
• Last Update Posted: Jun 7, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tri Bao Nguyen, Principle investigator, Hung Vuong Hospital: Laparoscopic surgery; Single-port laparoscope; Multi-port laparoscope
• Additional relevant MeSH terms: Pregnancy, Ectopic; Cardiac Complexes, Premature

Study Results

No Results Posted as of Jun 7, 2023