Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Hydrosalpinx and Planning for IVF

Comparative Study of Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Communicating Hydrosalpinx and Planning for IVF

compare the efficacy of hysteroscopic tubal occlusion versus laparoscopic tubal occlusion for the patients of communicating hydrosalpinx scheduled for IVF. half of the patients will undergo hysteroscopic tubal occlusion while the other half will undergo laparoscopic tubal occlusion.

Study Overview

• Status: Completed
• Conditions: Tubal Obstruction
• Intervention / Treatment: Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx

Detailed Description

The study will include 108 patients complaining of infertility associated with unilateral or bilateral tubal communicating hydrosalpinx. All the patients will be subjected to informed consent, history taking, full physical examination, ultrasound examination via transvaginal approach using ultrasound machine ( Voluson Pro-V and GE Voluson E 10) and HSG within the last 6 months showing unilateral or bilateral communicating hydrosalpinx.

The patients (108) will be equally randomized into two groups :

Group (A): 54 patients (Hysteroscopic tubal occlusion group). Group (B): 54 patients (Laparoscopic tubal occlusion group). Randomization will be done using 108 opaque sealed envelopes that will be numbered serially from 1-108 and each envelope corresponding letter which denotes the allocated group will be put according to randomization table then all envelopes will be closed and put in one box, when the first patient arrives, after giving informed consent, the first envelope will be opened and the patient will be allocated according to the letter inside.

For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area.

For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut. The contraindications for laparoscopy were mainly extensive abdominal or pelvic adhesions of various etiologies (e.g. previous surgery, pelvic inflammatory disease, and pelvic endometriosis) and morbid obesity.

The operative details of hysteroscopic tubal occlusion and laparoscopic tubal occlusion including operative time and complications will be documented In both groups, the patients will be followed up for the next 24 hours as regard post-operative pain (using VAS ) and post-operative recovery (patient mobilization, intestinal motility and patient discharge).

The success rate of tubal occlusion will be assessed one month later using post-menstrual HSG and for hysteroscopic group office hysteroscopy will be done for assessment of uterine cavity after electrocoagulation.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 22222
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Primary or secondary infertility.
• The presence of communicating hydrosalpinx diagnosed by HSG,TV U/S showing distended tubes and intrauterine fluid or patient complaining of prolonged brownish vaginal discharge.
• Candidate for IVF procedure.

Exclusion Criteria:

• Uterine anomalies.
• Serious medical condition and unfit for surgery.
• Contraindication for laparoscopic tubal occlusion.
• Contraindication for pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic tubal occlusion; 54 patients will undergo laparoscopic tubal occlusion.	Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx; For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area. For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut.
Active Comparator: Hysteroscopic tubal occlusion; 54 patients will undergo hysteroscopic tubal occlusion.	Procedure: Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx; For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area. For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with successful hysteroscopic tubal occlusion	Successful tubal occlusion will be measured by the presence of negative spill and proximal tubal block on HSG.	one month post-operative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with successful laparoscopic tubal occlusion	Successful tubal occlusion will be measured by the presence of negative spill and proximal tubal block on HSG.	one month post-operative.
The post-operative pain in both groups (using VAS ).	The patients will be followed up for the next 24 hours as regard post-operative pain (using VAS) .	24 hours post-operative.
The operative time and complications in both groups.	the operative time and operative complications will be documented according to the hospital records .	Intra-operative duration.
Compare the success rate of tubal occlusion in both groups.	The number of HSG that showed post-operative tubal occlusion in hysteroscopic group compared to laparoscopic group.	one month post-operative.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mahmoud A Abdelsalam, Msc, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Actual): August 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: July 27, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopy; Hysteroscopy; Hydrosalpinx
• Additional Relevant MeSH Terms: Adnexal Diseases; Fallopian Tube Diseases
• Other Study ID Numbers: 140689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No