Ectopic Pregnancy
Conditions
Keywords
natural orifice transluminal endoscopic surgery, laparoscopy, ectopic pregnancy, minimally invasive surgery, quality of life, sexual function
Brief summary
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.
Interventions
PROCEDURESalpingectomy
Patients will undergo removal of the affected tube
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults over 18 years of age, * Diagnosis of tubal ectopic pregnancy * Patient's preference to undergo salpingectomy
Exclusion criteria
* Patients with contraindication to endoscopic surgery * Refusal to sign informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate | During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month | — |
| Successful completion of surgery as intended | Intraoperative, from the beginning to the end of surgical intervention | The completion of the surgery with the route planned without having to change the surgical route |
| Operating time | Intraoperative | — |
| Complication rate | During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-40 questionnaire | Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery | The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points |
| The need for additional analgesic use | Postoperative period until discharge, expected to be up to 3 days following surgery | 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. |
| Quality of life change | Preoperative, Postoperative 1-month | Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points |
| Postoperative pain scores | 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 | Postoperative pain will be assessed on a 10-cm visual analog scale at different time points |
| Sexual function | Postoperative 3 months | Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months |
Countries
Turkey (Türkiye)
Contacts
Primary ContactGokay Ozceltik
Outcome results
None listed