NCT04315779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2020

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2021

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 17, 2020

Last Update Submit

March 18, 2020

Conditions

Ectopic Pregnancy

Keywords

natural orifice transluminal endoscopic surgerylaparoscopyectopic pregnancyminimally invasive surgeryquality of lifesexual function

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (5)

  • Quality of Recovery-40 questionnaire

    Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery

  • Quality of life change

    Preoperative, Postoperative 1-month

  • 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

  • Sexual function

    Postoperative 3 months

  • The need for additional analgesic use

    Postoperative period until discharge, expected to be up to 3 days following surgery

Study Arms (2)

Conventional laparoscopy

ACTIVE COMPARATOR

In this arm, patients will be treated via conventional laparoscopy

Procedure: Salpingectomy

Transvaginal natural orifice transluminal endoscopic surgery

ACTIVE COMPARATOR

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

Procedure: Salpingectomy

Interventions

SalpingectomyPROCEDURE

Patients will undergo removal of the affected tube

Conventional laparoscopyTransvaginal natural orifice transluminal endoscopic surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 18 years of age,
  • Diagnosis of tubal ectopic pregnancy
  • Patient's preference to undergo salpingectomy

You may not qualify if:

  • Patients with contraindication to endoscopic surgery
  • Refusal to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University University Hospital, Department of Obstetrics and Gynecology

Bornova, İzmir, 35100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Salpingectomy

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Gokay Ozceltik

CONTACT

+905330922020gokayozceltik@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 20, 2020

Study Start

February 19, 2020

Primary Completion

February 19, 2021

Study Completion

May 19, 2021

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

TU(1)