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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single-port laparoscopy | Procedure | Compare the effectiveness and safety between single-port and multi-port laparoscopic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Use visual analogue scale to measure | Within 4 weeks post surgery |
| Surgical complications | Organ damages, surgical site infections, pneumoperitoneum |
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Inclusion Criteria:
Exclusion Criteria:
The investigators only recruit patients with ectopic pregnancy to participate in the study
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tri B Nguyen, Doctor | Contact | 0983739959 | ngoc.lam@ttu.edu.vn | |
| NGOC T LAM, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nghiem X Huynh, Doctor | Hung Vuong Hospital | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 24, 2024 | |
| Reset | Jan 10, 2025 | |
| Release | Mar 29, 2026 | |
| Reset | Apr 21, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2023 | Jun 5, 2023 | Prot_SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 24, 2024 | Jan 10, 2025 | |||
| Mar 29, 2026 |
| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| Within 4 weeks post surgery |
| Hospital stay | How long will be the recovery time | Within 4 weeks post surgery |
| Apr 21, 2026 |