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

NCT ID: NCT04315779

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-19

Study Completion Date

2021-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Ectopic Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional laparoscopy

In this arm, patients will be treated via conventional laparoscopy

Group Type ACTIVE_COMPARATOR

Salpingectomy

Intervention Type PROCEDURE

Patients will undergo removal of the affected tube

Transvaginal natural orifice transluminal endoscopic surgery

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

Group Type ACTIVE_COMPARATOR

Salpingectomy

Intervention Type PROCEDURE

Patients will undergo removal of the affected tube

Interventions

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Salpingectomy

Patients will undergo removal of the affected tube

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Gokay Ozceltik

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ege University University Hospital, Department of Obstetrics and Gynecology

Bornova, İzmir, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Gokay Ozceltik

Role: CONTACT

+905330922020

Facility Contacts

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Gokay Ozceltik

Role: primary

+905330922020

Other Identifiers

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20-2.1T/40

Identifier Type: -

Identifier Source: org_study_id

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