Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy
Primary Purpose
Ectopic Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Salpingectomy
Sponsored by
About this trial
This is an interventional treatment trial for Ectopic Pregnancy focused on measuring natural orifice transluminal endoscopic surgery, laparoscopy, ectopic pregnancy, minimally invasive surgery, quality of life, sexual function
Eligibility Criteria
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.
Sites / Locations
- Ege University University Hospital, Department of Obstetrics and GynecologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional laparoscopy
Transvaginal natural orifice transluminal endoscopic surgery
Arm Description
In this arm, patients will be treated via conventional laparoscopy
In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery
Outcomes
Primary Outcome Measures
Successful completion of surgery as intended
The completion of the surgery with the route planned without having to change the surgical route
Operating time
Reoperation rate
Complication rate
Secondary Outcome Measures
Quality of Recovery-40 questionnaire
The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points
Quality of life change
Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points
Postoperative pain scores
Postoperative pain will be assessed on a 10-cm visual analog scale at different time points
Sexual function
Female sexual function index (FSFI) questionnaire will be self-administered by patients at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04315779
Brief Title
Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy
Official Title
Comparison of Conventional Laparoscopy and Natural Orifice Transluminal Endoscopic Surgery in the Surgical Treatment of Tubal Ectopic Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2020 (Actual)
Primary Completion Date
February 19, 2021 (Anticipated)
Study Completion Date
May 19, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy
Keywords
natural orifice transluminal endoscopic surgery, laparoscopy, ectopic pregnancy, minimally invasive surgery, quality of life, sexual function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional laparoscopy
Arm Type
Active Comparator
Arm Description
In this arm, patients will be treated via conventional laparoscopy
Arm Title
Transvaginal natural orifice transluminal endoscopic surgery
Arm Type
Active Comparator
Arm Description
In this arm, patients will be treated via transvaginal natural orifice transluminal endoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
Salpingectomy
Intervention Description
Patients will undergo removal of the affected tube
Primary Outcome Measure Information:
Title
Successful completion of surgery as intended
Description
The completion of the surgery with the route planned without having to change the surgical route
Time Frame
Intraoperative, from the beginning to the end of surgical intervention
Title
Operating time
Time Frame
Intraoperative
Title
Reoperation rate
Time Frame
During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Title
Complication rate
Time Frame
During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month
Secondary Outcome Measure Information:
Title
Quality of Recovery-40 questionnaire
Description
The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points
Time Frame
Preoperatively and Postoperative every 24 hours until discharge, expected to be up to 3 days following surgery
Title
Quality of life change
Description
Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points
Time Frame
Preoperative, Postoperative 1-month
Title
Postoperative pain scores
Description
Postoperative pain will be assessed on a 10-cm visual analog scale at different time points
Time Frame
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
Title
Sexual function
Description
Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months
Time Frame
Postoperative 3 months
Title
The need for additional analgesic use
Description
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.
Time Frame
Postoperative period until discharge, expected to be up to 3 days following surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gokay Ozceltik
Phone
+905330922020
Email
gokayozceltik@hotmail.com
Facility Information:
Facility Name
Ege University University Hospital, Department of Obstetrics and Gynecology
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gokay Ozceltik
Phone
+905330922020
Email
gokayozceltik@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison of Two Different Approaches in the Surgical Treatment of Tubal Ectopic Pregnancy
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