Surgical Approach to Uterine Septum

NCT06315582 | Recruiting

• 1 other identifier: STU00220487
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. The investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.

Conditions

Treatment Side Effects; Treatment; Uterine Septum; Surgical Complication; Septum; Uterus

Outcome Measures

Primary Outcomes (4)

• Procedure-level variables: operative time hysteroscopic septoplasty

  We will measure time it takes to conduct procedure

  During the intervention/procedure/surgery

• Procedure-level variables: Surgical Cost

  We will compare amount of money spent.

  During the surgery

• Procedure-level variables: Fluid deficit

  We will measure amount of fluid deficit which is a number that is generate by hysteroscope.

  During the surgery

• Resolution of uterine septum

  Compare septum resolution defined by being less than 1 cm in depth from the intertubal line and need for additional intervention following hysteroscopic septoplasty utilizing these two surgical techniques

  Assess at 4 weeks post-op hysteroscopy

Secondary Outcomes (2)

• Compare adverse events

  Immediate period-- 1 week post-operation

• Comparing patient recovery and satisfaction

  2 days postop

Study Arms (2)

Study Intervention A (control group)

ACTIVE COMPARATOR

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Procedure: Hysteroscopic septoplasty utilizing bipolar electrosurgery

Study Intervention B (study group)

EXPERIMENTAL

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Procedure: Removal of uterine septum with hysteroscopic scissors without electrosurgery.

Interventions

Removal of uterine septum with hysteroscopic scissors without electrosurgery. PROCEDURE

Hysteroscopic septoplasty utilizing scissors without electrosurgery followed by hysteroscopic morcellation of residual tissue

Study Intervention B (study group)

Hysteroscopic septoplasty utilizing bipolar electrosurgery PROCEDURE

Hysteroscopic septoplasty utilizing bipolar electrosurgery

Study Intervention A (control group)

Eligibility Criteria

• Age: 22 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a confirmed septum (\>1.0 cm) confirmed with 3D imaging and/or MRI
• years old

You may not qualify if:

• Known tubal disease
• Bleeding diastasis
• No blood thinners
• No concurrent laparoscopy scheduled
• Patient with confirmed fibroids over \>1 cm FIGO (International Federation of Gynecology and Obstetrics) type 1

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (8)

• Kalaitzopoulos DR, Themeli MZ, Grigoriadis G, Alterio MD, Vitale SG, Angioni S, Daniilidis A. Fertility, pregnancy and perioperative outcomes after operative hysteroscopy for uterine septum: a network meta-analysis. Arch Gynecol Obstet. 2024 Mar;309(3):731-744. doi: 10.1007/s00404-023-07109-2. Epub 2023 Jun 24.

  PMID: 37354236 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine. Electronic address: ASRM@asrm.org; Practice Committee of the American Society for Reproductive Medicine. Uterine septum: a guideline. Fertil Steril. 2016 Sep 1;106(3):530-40. doi: 10.1016/j.fertnstert.2016.05.014. Epub 2016 May 25.

  PMID: 27235766 BACKGROUND

• Dason ES, Mathur S, Murji A. Hysteroscopic septoplasty: many techniques, little evidence. Fertil Steril. 2021 Nov;116(5):1426-1427. doi: 10.1016/j.fertnstert.2021.09.001. Epub 2021 Oct 1. No abstract available.

  PMID: 34607705 BACKGROUND

• Budden A, Abbott JA. The Diagnosis and Surgical Approach of Uterine Septa. J Minim Invasive Gynecol. 2018 Feb;25(2):209-217. doi: 10.1016/j.jmig.2017.07.017. Epub 2017 Jul 26.

  PMID: 28755995 BACKGROUND

• Yang L, Wang L, Chen Y, Guo X, Miao C, Zhao Y, Li L, Zhang Q. Cold scissors versus electrosurgery for hysteroscopic adhesiolysis: A meta-analysis. Medicine (Baltimore). 2021 Apr 30;100(17):e25676. doi: 10.1097/MD.0000000000025676.

  PMID: 33907137 BACKGROUND

• Fatehi Hassanabad A, Zarzycki AN, Jeon K, Dundas JA, Vasanthan V, Deniset JF, Fedak PWM. Prevention of Post-Operative Adhesions: A Comprehensive Review of Present and Emerging Strategies. Biomolecules. 2021 Jul 14;11(7):1027. doi: 10.3390/biom11071027.

  PMID: 34356652 RESULT

• Carrera M, Perez Millan F, Alcazar JL, Alonso L, Caballero M, Carugno J, Dominguez JA, Moratalla E. Effect of Hysteroscopic Metroplasty on Reproductive Outcomes in Women with Septate Uterus: Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2022 Apr;29(4):465-475. doi: 10.1016/j.jmig.2021.10.001. Epub 2021 Oct 11.

  PMID: 34648934 RESULT

• LaMonica R, Pinto J, Luciano D, Lyapis A, Luciano A. Incidence of Septate Uterus in Reproductive-Aged Women With and Without Endometriosis. J Minim Invasive Gynecol. 2016 May-Jun;23(4):610-3. doi: 10.1016/j.jmig.2016.02.010. Epub 2016 Feb 23.

  PMID: 26922877 RESULT

MeSH Terms

Conditions

Septate Uterus

Interventions

Electrosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Sarah L Rodriguez, MD

CONTACT

7863011284; sarah.rodriguez@nm.org

Milad Madgy, MD

CONTACT

mmilad@nm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be randomized using www.randomizer.org algorithm. They will be assigned to arm in the operating room where they will get that intervention. When they get to Post Anesthesia Care Unit, they will be unblinded. Surgeon will be blinded until patient is in operating room and envelope with randomization is opened.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Minimally Invasive Gynecologic Surgery in the Department of Obstetrics and Gynecology at Northwestern University

Model Details: Randomized single blinded study

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 18, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): October 26, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)