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Not yet recruitingNCT07007130Updated Jun 5, 2025

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

An interventional study of Actrapid insulin and Normal saline in Prevention of Postoperative Adhesions, sponsored by Ain Shams University. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

Read the detailed description

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.

02

Conditions studied

  • Prevention of Postoperative Adhesions
03

In context

Recurrence

4,278 studies on the registry are indexed under Recurrence; 987 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 3,373 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Intervention group

    Drug: Actrapid insulin

  • Sham comparator
    Control group

    Drug: Normal saline

Interventions

  • DrugActrapid insulin

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

  • DrugNormal saline

    100 mL normal saline intraperitoneally

06

What researchers measure

Primary outcomes

  1. Adhesion scoring at second-look laparoscopy

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

    Time frame: 4-6 weeks postoperatively

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

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07007130
Lead sponsor
Ain Shams University
Responsible party
RAMY AHMED (Asisstant professor, Ain Shams University) — Principal investigator
First posted
Jun 5, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Mar 1, 2026 (estimated)
Completion
Mar 1, 2026 (estimated)
Last update
Jun 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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