Comparative Study Between Hormonal and Hysteroscopic Management of Cesarean Scar Defect

Comparative Study Between Hysteroscopic Management of Cesarean Scar Defect and Hormonal Treatment. A Randomized Controlled Trial

Up to 70% of women who have had a previous caesarean section experience uterine niche, with 30% having symptoms. Prevalence rates vary between 24-70% using transvaginal ultrasonography and 56-84% using gel/saline instillation sonohysterography. Classification involves the ratio of myometrial thickness at the scar to adjacent myometrium, with severe deficiency defined by a ratio of ≤50%. Dehiscence is defined as at least 80% myometrial thinning.

The aim of this work was to compare between the effectiveness of two different techniques of hysteroscopic ablation of cesarean scar defect and hormonal treatment to improve abnormal uterine bleeding and pelvic pain localized in the suprapubic area associated with isthmocele.

Study Overview

• Status: Completed
• Conditions: Cesarean Scar Defect
• Intervention / Treatment: Procedure: hysteroscopic surgery by resection and endocoagulation; Procedure: hysteroscopic surgery by endocoagulation only; Drug: hormonal treatment

Detailed Description

The study include 78 women diagnosed with abnormal uterine bleeding (AUB). All cases were subjected for complete history taking, complete general and gynaecological examination, vaginal ultrasonography (TVUS) to confirm niche and exclude other pathologies. The women were randomly divided by1:1:1 ratio into three equal groups using double blind method with closed envelopes

Group A: include 26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media.

Group B: include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media.

Group C: include 26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months.

Follow up was done after 1, 3, 6 months, by TVUS to exclude presence of symptoms of abnormal uterine bleeding (AUB) and to assess different outcome measures including presence or absence of intermenstrual spotting, presence or absence of postcoital bleeding, presence or absence of Pelvic tenderness or dyspareunia

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Tamer
  • Alexandria, Egypt
    • El shatby hospital Alexandria university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• women with age ranging from 25 to 42 years,
• previous cesarean section,
• presence of a cesarean scar defect on ultrasound with a residual myo3metrium of > 1.5 mm.

Exclusion Criteria:

• any contraindications of hysteroscopy as an active pelvic infection, active genital herpes,
• Contraindications to hormonal treatment as medical conditions like breast cancer, history of deep venous thrombosis, Previous arterial thrombosis, pulmonary embolism, active liver disease, use of rifampicin, familial hyperlipidemia, pregnancy,
• patient refusal
• Any Other causes of abnormal uterine bleeding as polyp, adenomyosis. leiomyoma, malignancy, coagulopathy. and ovulatory disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hysteroscopic resection; 26 patients subjected to hysteroscopic surgery in the form of resection of lower edge, resection of upper edge and endocoagulation to fulgurate the visible dilated blood vessels or endometrial-like glands inside the base of the niche by using a roller ball resectoscope with monopolar electrical current and glycine as distension media.	Procedure: hysteroscopic surgery by resection and endocoagulation; resection of lower edge, resection of upper edge and endocoagulation
Experimental: hysteroscopic endocoagulation; include 26 patients subjected to hysteroscopic endocoagulation to the base of the niche by roller ball using monopolar electrical current and glycine as distension media.	Procedure: hysteroscopic surgery by endocoagulation only; hysteroscopic endocoagulation to the base of the niche by roller ball
Experimental: hormonal treatment; 26 patients received hormonal treatment in the form of 3rd generation combined oral contraceptive pills in a cyclic manner for 6 months.	Drug: hormonal treatment; using 3rd generation contraceptive pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence or absence of intermenstrual spotting,	improvement of intermenstrual spotting in group a and B from 1 st month , and improvment in all groups after 6 months	6 months
presence or absence of postcoital bleeding	improvement of postcoital bleeding in all groups after 6 months	6 months
presence or absence of pelvic tenderness or dyspareunia	improvement of postcoital bleeding in all groups after 6 months	6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: hormonal treatment; cesarean scar defect; hysteroscopic resection; hysterscopic treatment; endocoagulation
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: 0107228

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No