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PURPOSE: The objective of the trial was to compare the regression rate of atypical endometrial hyperplasia (AEH) in patients treated with megestrol acetate (MA) vs. levonorgestrel-intrauterine device (LNG-IUS). We also aimed to assess the fertility and pregnancy outcomes in these patients. METHODS: The study was a phase II multi-centre randomised controlled trial on the use of MA compared to LNG-IUS in the treatment of AEH conducted from January 2020 to January 2024 in Singapore. Women who were diagnosed with AEH and between 21 and 40 years old were included. The patients were randomised to receive either MA (160 mg orally daily) or LNG-IUS. The primary outcomes assessed were the regression rates at 3 months, 6 months and 9 months of treatment. The secondary outcomes assessed were the side effects, patient acceptability and fertility outcomes. RESULTS: Thirty-six patients completed the trial. The overall regression rate was 88.9% by 9 months. There was no statistically significant difference in the 9-month complete regression rate between MA vs. LNG-IUS. There was also no significant difference in side effects and weight change between both arms. Nineteen patients were actively pursuing fertility after complete regression. There were 8 pregnancies achieved, with resultant 4 live births and 4 miscarriages. CONCLUSION: Our study confirms a high regression rate of AH with medical treatment. LNG-IUS is a non-inferior treatment compared to megestrol acetate. Successful pregnancy outcomes can be achieved after regression of AEH. Long-term studies of sufficient sample-size are needed to assess for fertility and pregnancy outcomes, risk of recurrence and long-term risk of malignancy. TRIAL REGISTRATION NUMBER: The study was registered with the Health Science Authority (HSA) (License No.: CTA1900087) on September 5, 2019: https://eservice.hsa.gov.sg/prism/ct_r/enquiry.do?action=loadSpecificDetail . The trial was registered retrospectively on ClinicalTrials.gov (ID: NCT05492487) on April 7, 2022: https://clinicaltrials.gov/study/NCT05492487 .
RESUMO
The current literature suggests that serious complications after intrauterine contraceptive device (IUCD) insertion are rare. We present a rare case of a migrated IUCD into the rectosigmoid colon. A 33-year-old woman (parity one) presented to the emergency department with a three-day history of flank pain, upper urinary tract infection symptoms, and a low-grade fever. Differentials initially included renal colic or pyelonephritis. However, subsequent computed tomography of the kidneys, ureters, and bladder (CT-KUB) and magnetic resonance imaging of the pelvis (MRI-pelvis) showed a migrated IUCD posterior to the uterine body, with both ends closely abutting onto the adjacent proximal rectum. During further history-taking, she reported a past surgical history of an emergency caesarean section five years ago and the insertion of a copper-IUCD six weeks postnatally. She was subsequently referred to the gynaecologists. In view of the involvement of the bowels, the colorectal surgeons were consulted, and the patient was managed by a multidisciplinary team. The patient subsequently underwent diagnostic hysteroscopy, flexible sigmoidoscopy, diagnostic laparoscopy, removal of impacted IUCD, and repair of the rectum. Intraoperatively, her hysteroscopy noted a normal uterus with an intact cavity. Flexible sigmoidoscopy noted the horizontal arm of the IUCD abutting into the lumen of the rectosigmoid region; however, attempted removal with traction was unsuccessful. A partial rectotomy was done eventually to remove the IUCD. Migration of an IUCD is rare, with uterine perforation rates ranging from 0.04% to 0.2%. Albeit a rare complication, this case highlights the need for clinicians to be cognizant of complications arising from IUCD insertion, as symptoms are often non-specific and mild. This case also highlights the importance of a multidisciplinary discussion in the management of a migrated IUCD, which may include gynaecologists, colorectal surgeons, radiologists, and more. Many innovative ways were also discussed regarding the assessment of it, which includes preoperative imaging or endoscopic evaluation. Novel methods of removal of migrated IUCD in the rectosigmoid colon have also been proposed, including manual traction, proctoscopy, rigid sigmoidoscopy, and removal via a snare. They provide an alternative to the traditional diagnostic laparoscopy or laparotomy, thus reducing the need for general anaesthesia or operative intervention. Looking forward, long-term studies can be done to evaluate the need for intervention for asymptomatic patients where the risk of surgery may outweigh the benefits.