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In this study we aim to compare conventional laparoscopy and natural orifice transluminal endoscopic surgery in the surgical treatment of ectopic pregnancy.
All the patients, with an indication of surgery for ectopic pregnancy, will be asked to participate in this clinical trial.
Indication of surgery will be based on clinical findings, ultrasound scans and serum hcg levels. There will be no exclusion criteria.
Duration of surgery, successful completion of the operation, intraoperative data and postoperative data will be collected.
All the patients will be asked to fill out quality of recovery-40 (QoR-40) questionnaire and 36-item short form health survey (SF-36) before surgery.
QoR-40 questionnaire will be repeated 24 hours after surgery and repeated every 24 hours until discharge. SF-36 will be repeated at 1-month follow-up visit. Patients will be also evaluated at postoperative 3-months, and female sexual function index will be asked to be filled-out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional laparoscopy | Active Comparator | In this arm, patients will be treated via conventional laparoscopy |
|
| Transvaginal natural orifice transluminal endoscopic surgery | Active Comparator | In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salpingectomy | Procedure | Patients will undergo removal of the affected tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful completion of surgery as intended | The completion of the surgery with the route planned without having to change the surgical route | Intraoperative, from the beginning to the end of surgical intervention |
| Operating time | Intraoperative | |
| Reoperation rate | During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month | |
| Complication rate | During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-40 questionnaire | The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points | Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery |
| Quality of life change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gokay Ozceltik | Contact | +905330922020 | gokayozceltik@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University University Hospital, Department of Obstetrics and Gynecology | Recruiting | Bornova | İzmir | 35100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D058994 | Salpingectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points |
| Preoperative, Postoperative 1-month |
| Postoperative pain scores | Postoperative pain will be assessed on a 10-cm visual analog scale at different time points | Postoperative 2 hours, 6 hours, 12 hours, 24 hours, and every 24 hours until discharge (if the patient stays longer than 1 day at the hospital), , expected to be up to 3 days following surgery |
| Sexual function | Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months | Postoperative 3 months |
| The need for additional analgesic use | Patients will be routinely administered pethidine hydrochloride 3x50 mg parenteral on the day of surgery. Starting from postoperative day 1 patients will be administered paracetamol 500 mg oral upon their request. In case of inadequate pain relief and the need for additional analgesic use will ve recorded. | Postoperative period until discharge, expected to be up to 3 days following surgery |