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

NCT07007130 | Not Yet Recruiting

• 1 other identifier: Dr Sayed Elakhras study
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prevention of Postoperative Adhesions

Outcome Measures

Primary Outcomes (1)

• Adhesion scoring at second-look laparoscopy

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

  4-6 weeks postoperatively

Secondary Outcomes (4)

• Postoperative pain scores

  Immediately after operation

• Hypoglycemic events

  2 hours after the operation

• Hypoglycemic events

  4 hours after the operation

• Fertility rates

  At 6 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Drug: Actrapid insulin

Control group

SHAM COMPARATOR

Drug: Normal saline

Interventions

Actrapid insulin DRUG

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

Intervention group

Normal saline DRUG

100 mL normal saline intraperitoneally

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

insulin, neutral; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-05