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NCT Number: NCT07007130

Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial

Adhesion formation following laparoscopic pelvic surgery remains a significant cause of chronic pelvic pain, infertility, and surgical complications. Patients with insulin resistance (IR) may have heightened inflammatory responses and impaired tissue healing, contributing to a higher risk of adhesion formation. Intraperitoneal administration of insulin has shown promising results in animal models by modulating inflammatory mediators and enhancing fibrinolysis. This trial aims to evaluate the efficacy and safety of intraperitoneal insulin instillation at the end of laparoscopy in women with insulin resistance.

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Key information

Conditions

Prevention of Postoperative Adhesions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

This is a prospective, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy of intraperitoneal insulin administration at the end of laparoscopic surgery in women with insulin resistance, aiming to reduce postoperative adhesion formation. The study will be conducted at a dr saed hospital and will enroll 100 female patients diagnosed with insulin resistance undergoing laparoscopy for infertility or chronic pelvic pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-40 years
  • Diagnosed insulin resistance (e.g., HOMA-IR >2.5 or fasting insulin >15 uIU/mL)
  • Indicated for laparoscopy for infertility or pelvic pain
  • BMI 20-35 kg/m²
  • Able and willing to give informed consent

Exclusion criteria

  • Diabetes mellitus requiring pharmacologic treatment
  • History of peritonitis or major abdominal surgery in the past 6 months
  • Known allergy or sensitivity to insulin
  • Chronic steroid or immunosuppressive use
  • Pregnancy or lactation
  • Participation in another clinical trial within the last 3 months

Treatment and study plan

Actrapid insulin

Drug

0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure

normal saline

Drug

100 mL normal saline intraperitoneally

Primary outcomes

  1. Adhesion scoring at second-look laparoscopy

    Time frame: 4-6 weeks postoperatively

    Adhesion scoring at second-look laparoscopy (4-6 weeks postoperative)

Secondary outcomes

  1. Postoperative pain scores

    Time frame: Immediately after operation

  2. Hypoglycemic events

    Time frame: 2 hours after the operation

  3. Hypoglycemic events

    Time frame: 4 hours after the operation

  4. Fertility rates

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.