## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 20-2.1T/40
#### Organization
**Class:** OTHER
**Full Name:** Ege University
### Status Module
#### Completion Date
**Date:** 2021-05-19

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-03-20

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-02-19

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-02-19

**Type:** ACTUAL

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2020-03-20
**Type:** ACTUAL
**Study First Submit Date:** 2020-03-17
**Study First Submit QC Date:** 2020-03-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ege University

#### Responsible Party

**Investigator Affiliation:** Ege University

**Investigator Full Name:** Gokay Ozceltik

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Ectopic Pregnancy

**Keywords:**

- natural orifice transluminal endoscopic surgery

- laparoscopy

- ectopic pregnancy

- minimally invasive surgery

- quality of life

- sexual function

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In this arm, patients will be treated via conventional laparoscopy

**Intervention Names:**

- Procedure: Salpingectomy

**Label:** Conventional laparoscopy

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

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

**Intervention Names:**

- Procedure: Salpingectomy

**Label:** Transvaginal natural orifice transluminal endoscopic surgery

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Conventional laparoscopy

- Transvaginal natural orifice transluminal endoscopic surgery

**Description:** Patients will undergo removal of the affected tube

**Name:** Salpingectomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** The completion of the surgery with the route planned without having to change the surgical route

**Measure:** Successful completion of surgery as intended

**Time Frame:** Intraoperative, from the beginning to the end of surgical intervention

**Measure:** Operating time

**Time Frame:** Intraoperative

**Measure:** Reoperation rate

**Time Frame:** During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month

**Measure:** Complication rate

**Time Frame:** During follow-up, after surgery until hcg level drops below 5 U/L, up to 1 month

#### Secondary Outcomes

**Description:** The Quality of Recovery 40 questionnaire will be self-administered by patients at different time points

**Measure:** Quality of Recovery-40 questionnaire

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

**Description:** Short form 36 item health survery (SF-36) questionnaire will be self-administered by patients at different time points

**Measure:** Quality of life change

**Time Frame:** Preoperative, Postoperative 1-month

**Description:** Postoperative pain will be assessed on a 10-cm visual analog scale at different time points

**Measure:** Postoperative pain scores

**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

**Description:** Female sexual function index (FSFI) questionnaire will be self-administered by patients at postoperative 3-months

**Measure:** Sexual function

**Time Frame:** Postoperative 3 months

**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.

**Measure:** The need for additional analgesic use

**Time Frame:** Postoperative period until discharge, expected to be up to 3 days following surgery

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gokayozceltik@hotmail.com

**Name:** Gokay Ozceltik

**Phone:** +905330922020

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bornova

**Contacts:**

***Contact 1:***

- **Email:** gokayozceltik@hotmail.com

- **Name:** Gokay Ozceltik

- **Phone:** +905330922020

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Ege University University Hospital, Department of Obstetrics and Gynecology

**State:** Izmir

**Status:** RECRUITING

**Zip:** 35100

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000075224

- Term: Cardiac Conduction System Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14147

- Name: Pregnancy, Ectopic

- Relevance: HIGH

- As Found: Ectopic Pregnancy

- ID: M14150

- Name: Pregnancy, Tubal

- Relevance: HIGH

- As Found: Tubal Ectopic Pregnancy

- ID: M8260

- Name: Cardiac Complexes, Premature

- Relevance: HIGH

- As Found: Ectopic

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M1472

- Name: Cardiac Conduction System Disease

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

- ID: T2035

- Name: Ectopic Pregnancy

- Relevance: HIGH

- As Found: Ectopic Pregnancy

### Condition Browse Module - Meshes

- ID: D000011271

- Term: Pregnancy, Ectopic

- ID: D000011274

- Term: Pregnancy, Tubal

- ID: D000005117

- Term: Cardiac Complexes, Premature

### Misc Info Module

- Version Holder: 2024-05-24
