None listed
Conditions
Brief summary
This pilot randomised controlled trial will evaluate whether intraperitoneal administration of 4% Icodextrin (Adept®) at the completion of laparoscopic excision of advanced endometriosis can reduce postoperative ovarian adhesions. Forty women with intra-operative evidence of fixed or immobile ovaries will be randomised 1:1 to receive either Icodextrin or no adhesion-reduction solution. The primary outcome is ovarian mobility at 3 months, assessed by transvaginal ultrasound using a standardised sliding-sign protocol. Secondary outcomes include pain improvement (VAS), operative and recovery parameters, and safety events. Findings will inform the feasibility and design of a larger multicentre trial aimed at improving fertility and pain outcomes in endometriosis surgery.
Interventions
Procedure:
At the end of the surgery, a 1000 mL volume of 4% icodextrin solution will be instilled into the pelvic cavity. The solution will be administered by the operating gynaecologist. It will be applied throughout all accessible areas of the pelvic cavity, according to the manufacturer's directions for intra-peritoneal use.
Adherence Monitoring:
Adherence to the intervention will be monitored through documentation in the operation report, including confirmation of volume administered. The
Procedure: At the end of the surgery, a 1000 mL volume of 4% icodextrin solution will be instilled into the pelvic cavity. The solution will be administered by the operating gynaecologist. It will be applied throughout all accessible areas of the pelvic cavity, according to the manufacturer's directions for intra-peritoneal use. Adherence Monitoring: Adherence to the intervention will be monitored through documentation in the operation report, including confirmation of volume administered. The solution bag will be checked and recorded before and after use to verify the instilled volume.
Sponsors
Mater Mother Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
- Female patients aged 18–50 years - Undergoing elective laparoscopic surgery for advanced endometriosis with fixed or immobile ovary/ovaries identified intra-operatively - Ovarian mobility assessed pre-operatively by transvaginal ultrasound (TVUS) confirming reduced or absent mobility -Able to provide informed consent and willing to participate in post-operative follow-up, including 3-month TVUS assessment - Negative pregnancy test within 72 hours of surgery (if of child-bearing potential) - Adequate renal function (estimated GFR above 45 mL/min/1.73 m²) - No known allergy or hypersensitivity to icodextrin, maltose, or related compounds
Exclusion criteria
- Known hypersensitivity or allergy to icodextrin, maltose, starch derivatives, or any component of the study solution - Significant renal impairment, defined as estimated glomerular filtration rate (eGFR <45 mL/min/1.73 m²) - Pregnancy or breastfeeding at the time of enrolment - Uncontrolled diabetes mellitus or use of glucose monitoring systems known to be affected by icodextrin metabolites - Concurrent participation in another interventional clinical trial within the previous 30 days - Unexpected intra-operative findings precluding safe instillation of the study solution (e.g., bowel perforation, haemodynamic instability) - Inability to provide informed consent or comply with follow-up visits (e.g., cognitive impairment, language barrier without interpreter support)
Outcome results
None listed