The effect of the laparoscopic reconstruction of a caesarean scar (?Niche?)

Not Applicable

Completed

• Conditions: Abnormal Uterine Bleeding / Niche resection; Surgery

• Registration Number: ISRCTN02271575
• Lead Sponsor: VU University Medical Center (Netherlands)

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37700545/ Long-term follow-up (added 14/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-27
• Study Completion: 2018-01-31
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 133

Inclusion Criteria

1. A niche with residual myometrium < 3 mm (as measured with SIS / GIS)
2. Complaints of abnormal uterine blood loss, dysmenorrhoea or accumulation of intracavitary fluid
3. Premenopausal women aged above 18

Exclusion Criteria

1. Pregnancy
2. Age below 18
3. Other disorders that may induce spotting [polyps (everywhere in the uterus/cervix are exclusion criteria except those in the niche)], fibroids, known atypical endometrial cells, cervical dysplasia, cervical or pelvic infection, assumed malignancy, irregular cycle (>35 days or intercycle variation of 2 weeks or more)
4. Contra-indications for spinal or general anaesthesia

Study & Design

• Study Type: Observational
• Study Design: Not specified