Hysteroscopic Septoplasty by Different Modalities
Condition: Septate Uterus; Recurrent Pregnancy Loss; Subfertility
MeSH terms: Infertility; Septate Uterus
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare in participant population ( women with uterine
      septum meeting the inclusion criteria) hysteroscopic septoplasty by resectoscope compared to
      hysteroscopic septoplasty with scissors.

      The main questions to answer are:

      Is there a difference in operative time ? Is there a difference in fluid used and fluid
      deficit? Is there a difference in complications? Is there a difference in reproductive
      outcome? Researchers will compare the 2 different techniques to see if there is any
      difference in operative outcome ( operative time, fluid used and deficit, need for second
      intervention, and operative and postoperative complications) and reproductive outcome.
    

Detailed description: 
      Study design:

      Prospective randomized clinical trial

      Study duration and location:

      For at least 24 months, Patients admitted to Obstetrics and Gynecology department at Mansoura
      University Hospital.

      Study method

      At baseline, the following will be done:

        1. History taking: personal history, menstrual history, obstetrical and gynecological
           history, present and past history.

        2. Patient presentation (subfertility or pregnancy loss)

        3. Physical examination: General, abdominal and local examination.

        4. Diagnosis of uterine septum either by hysterosalpingogram (HSG), Three dimensional
           transvaginal ultrasound or office hysteroscopy.

      Thereafter:

      Patients will be prospectively recruited and randomized by computer program to 2 groups

      Group A:

      Patients in this group will undergo resection of the septum with hysteroscope and scissors.
      Saline will be used as a distending medium in the scissors group. Septal incision will be
      carried out using a thinning technique by which incisions will be made along each side of the
      septum alternately from one cornual end to the other

      Group B:

      Patients in this group will undergo resection of the septum with monopolar resectoscope ,
      dilation of cervical os with Hegar's dilators , incision of the septum using a resectoscope
      with the Collins knife, monopolar energy (cut 50-70 Watt) and glycine 1.5% as the distension
      medium Sample size calculation Sample size was calculated using Power Analysis and Sample
      Size software program (PASS) version 15.0.5 for windows (2017) using the results published
      before with the operative duration of hysteroscopic incision in septate uterus by scissors
      compared to resectoscope as the primary outcome. The study reported the median operative
      duration as 10 minutes for resectoscope while that for scissors was 30 minutes. The null
      hypothesis was considered as the absence of difference between both groups regarding the
      operative duration. A sample size of 16 patients in each group is needed to achieve 95% power
      (1-β or the probability of rejecting the null hypothesis when it is false) in the proposed
      study using a two-sided Fisher exact test with a significance level (α or the probability of
      rejecting the null hypothesis when it is true) of 5% and hypothesized common standard
      deviation 15 in both groups. 4 patients drop-out is expected, so a total of 20 patients will
      be enrolled to each group

      Statistical analysis Data will be analyzed using the Statistical Package of Social Science
      (SPSS) program for Windows (Standard version 24). The normality of data will be first tested
      with one-sample Kolmogorov-Smirnov test.

      Qualitative data will be described using number and percent. Continuous variables will be
      presented as mean ± standard deviation for normally distributed data and median (IQR) for
      non-normal data. The following tests will be used; Chi square test: Compare qualitative
      variables. Fisher exact test and monte carlo test: Compare qualitative variables when
      expected count less than 5.

      Independent t- test: Compare two quantitative variables (parametric). Mann Whitney test:
      Compare two quantitative variables (Non parametric). For all above mentioned statistical
      tests , the threshold of significance is fixed at 5% level.The results was considered
      significant when p ≤ 0.05. The smaller the p-value obtained, the more significant are the
      results.

      Ethical consideration:

        -  Study protocol was submitted for approval by Institutional Review Board

        -  Approval of the managers of the health care facilities in which the study was conducted.

        -  Informed written consent will be obtained from each participant sharing in the study.

        -  Confidentiality and personal privacy will be respected in all levels of the study.

        -  Collected data will not be used for any other purpose.
    

Intervention name(s): Hysteroscopic septoplasty with scissors; Hysteroscopic septoplasty with resectoscope
Intervention type(s): Procedure; Procedure
Intervention description(s): In hysteroscopic septoplasty with scissors arm, incision of the septum was done by continuous flow hysteroscopy and scissors using saline as distension media.; In hysteroscopic septoplasty with resectoscope arm, incision of the septum was done by 26 Fr monopolar resectoscope with collin's knife using glycine1.5% as distension media.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment