Chromotubation on the Remaining Fallopian Tube After a Laparoscopic Salpingectomy Due to Tubal Pregnancy

NCT06554964 | Not Yet Recruiting

• 1 other identifier: 0135-24-ASF
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ectopic pregnancy prevalence is approximately 1-2% of all pregnancies, majority of which located in the fallopian tube. Among the risk factors for ectopic pregnancy is tubal factor - meaning a mechanical problem within the fallopian tube resulting in the pregnancy remaining in the fallopian tube. The treatment o tubal pregnancy can be expectant, medical via metotrexate or surgicl via laparoscopic salpingectomy of the involved fallopian tube. The purpose of this study is to assess the feasibility of chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy hence assessing the function of the remaining fallopian tube and trying to predict future fertility for the patient.

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• Precentage of successful chromotubation (passing of blue dye through the fallopian tube) during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.

  How many cases would demonstrate patent fallopian tube via blue dye injected verses how many occluded ones.

  1 year

Secondary Outcomes (1)

• Percentage of adverse reaction to chromotubation during laparoscopic salpingectomy for the surgical management of tubal ectopic pregnancy.

  1 year

Study Arms (1)

Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.

EXPERIMENTAL

Patient undergoing laparoscopic salpingectomy due to ectopic tubal pregnancy will be offered chromotubation as the same tome in order to asess the potency of the remaining fallopian tube. Data will be recorded.

Procedure: performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube

Interventions

performing chromotubation during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube PROCEDURE

Performing chromotubation )injection of blue dye to the fallopian tube via cevical catheter) during the laparoscopy in order to assess the tubal patency of the remaining fallopian tube

Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The subjects in this study are patients with ectopic pregnancy hence are females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.

You may not qualify if:

• Patients with a history of unilateral salpingectomy
• Patients with suspected heterotopic pregnancy
• Patients with suspected allergic reaction to blue dye injection

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Neta Eisenberg-Kogan, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neta Eisenberg-Kogan, MD

CONTACT

+972542573878; netaeis3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician in the gynecology endoscopy unit

Model Details: Prospective non-randomized cohort study including patients undergoing laparoscopic salpingectomy for tubal ectopic pregnancy.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 15, 2024
• Study Start: September 30, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: date will be shared once study is complected for unlimited time
• Access Criteria: date will be shared in relevant publications