Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy

Ege University

Status: Unknown

Conditions: Ectopic Pregnancy

Treatments: Procedure: Salpingectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04315779

20-2.1T/40

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Conventional laparoscopy

Active Comparator group

Description:

In this arm, patients will be treated via conventional laparoscopy

Treatment:

Procedure: Salpingectomy

Transvaginal natural orifice transluminal endoscopic surgery

Active Comparator group

Description:

In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery

Treatment:

Procedure: Salpingectomy