Hysteroscopic Septoplasty by Different Modalities

NCT05802784 | Completed

• 1 other identifier: MD.20.05.324
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Septate Uterus; Recurrent Pregnancy Loss; Subfertility

Outcome Measures

Primary Outcomes (4)

• Operative time

  During surgery

• Fluid deficit

  During surgery

• Operative and post operative complications

  3 months follow up after intervention

• Need for second intervention

  3 months follow up after intervention

Secondary Outcomes (2)

• Pregnancy rate

  At least 6 months follow up after intervention

• Live birth rate

  Follow up until the end of first clinical pregnancy or 6 months after surgery

Study Arms (2)

Scissors arm

ACTIVE COMPARATOR

Patients in this group had undergone resection of the septum with hysteroscope and scissors, The scissors used was pointed, single action and semi rigid . Saline was used as the distending medium in the scissors group. Septal incision was carried out using shortening technique by incising the septum at the leading edge and continue dividing by moving from side to side (in narrow septum), or by thinning technique by which incisions will be made along each side of the septum alternately from one cornual end to the other (in broad septum). The operation was stopped if the fluid deficit exceeded 2500 ml of saline.

Procedure: Hysteroscopic septoplasty with scissors

Resectoscope arm

ACTIVE COMPARATOR

Patients in this group had undergone resection of the septum with Monopolar 26 French resectoscope Dilation of cervical os with Hegar's dilator (up to hegar 8 or 9) , incision of the septum using a resectoscope with the Collins knife, monopolar energy (cut 40-70 Watt) and glycine 1.5% as the distension medium, using shortening or thinning incision. The operation was stopped if the fluid deficit exceeded 1000 ml of glycine. The delivery of distension media was conducted by automated pressure delivery system. All patients were prescribed cyclic estrogen and progesterone for two months.

Procedure: Hysteroscopic septoplasty with resectoscope

Interventions

Hysteroscopic septoplasty with scissors PROCEDURE

In hysteroscopic septoplasty with scissors arm, incision of the septum was done by continuous flow hysteroscopy and scissors using saline as distension media.

Scissors arm

Hysteroscopic septoplasty with resectoscope PROCEDURE

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.

Resectoscope arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women of reproductive age
• Seeking conception
• Diagnosis of a septate or subseptate uterus
• A history of one of the following:
• Recurrent pregnancy loss
• Subfertility
• Preterm Birth

You may not qualify if:

• Not seeking conception
• Diagnosis of septate or subseptate uterus with no history of any of the following:
• Recurrent pregnancy loss
• Subfertility
• Preterm Birth
• Contraindications for surgery
• Those who refused to participate.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Faculty of medicine, Mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

MeSH Terms

Conditions

Septate Uterus; Infertility

Condition Hierarchy (Ancestors)

Uterine Duplication Anomalies; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 7, 2023
• Study Start: June 16, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 21, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

EG (1)