Clinical trial NCT05802784: Hysteroscopic Septoplasty by Different Modalities
Official title: Hysteroscopic Septoplasty by Different Modalities: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septate Uterus
Recurrent Pregnancy Loss
Subfertility
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Women of reproductive age
2. Seeking conception
3. Diagnosis of a septate or subseptate uterus
4. A history of one of the following:

   * Recurrent pregnancy loss
   * Subfertility
   * Preterm Birth

Exclusion Criteria:

1. Not seeking conception
2. Diagnosis of septate or subseptate uterus with no history of any of the following:

   * Recurrent pregnancy loss
   * Subfertility
   * Preterm Birth
3. Contraindications for surgery
4. Those who refused to participate.

Primary outcomes:
measure: Operative time
timeFrame: During surgery
measure: Fluid deficit
timeFrame: During surgery
measure: Operative and post operative complications
timeFrame: 3 months follow up after intervention
measure: Need for second intervention
timeFrame: 3 months follow up after intervention
Secondary outcomes:
measure: Pregnancy rate
timeFrame: At least 6 months follow up after intervention
measure: Live birth rate
timeFrame: Follow up until the end of first clinical pregnancy or 6 months after surgery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of medicine, Mansoura university
state: Dakahlia
Study officials:
References: