Hysteroscopic Versus Laparoscopic Tubal Occlusion in Cases of Hydrosalpinx and Planning for IVF
Condition: Tubal Obstruction
MeSH terms: Fallopian Tube Diseases
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hysteroscopy; Laparoscopy; Hydrosalpinx