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New Cross Linked Hyaluronan Gel After Deep Infiltrating Endometriosis Surgery

NCT04023383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-15

No results posted yet for this study

Summary

Hyaluronan, a glycosaminoglycan found in connective tissues and extracellular matrix, has been postulated to reduce postoperative adhesions, because of its unconditioned biological functions at tissue repair but unfortunately it has a fluid nature that causes rapid degradation, and it cannot effect long enough to work as an adhesion barrier.(10,11) For this reason a New cross-linked hyaluronan (NCH) gel, that has higher viscosity compared to natural hyaluronan has been developed by BioRegen Biomedical (Changzhou, Jiangsu, China). It has the ability for gradually absorption within 1 to 2 weeks in vivo, which are the acquired repair period and the critical time for adhesion formation. Although it seems evident that endometriosis has a serious impact on the daily Quality of Life of women; comparable data for the effect of adhesion barriers to patients who have had laparoscopic (Deep infiltrating endometriosis) DIE surgery is missing.

Therefore a pilot randomised controlled study was conducted to evaluate the effect of NCH gel on short term quality of life in patients who had undergone laparoscopic surgery due to DIE.

Conditions

  • Endometriosis
  • Adhesion
  • Quality of Life
  • Surgery

Interventions

DRUG

40 cc HyaRegen NCH gel

After an extensive bleeding control the patients in the intervention group had 40 mL of HyaRegen NCH gel instilled into the peritoneal cavity.

DRUG

40 cc sterile saline solution

After an extensive bleeding control the patients in the control group had 40 cc sterile saline solution compatible with the body temperature.

Sponsors & Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    lead OTHER_GOV

Principal Investigators

  • Murat Ekin, MD · Bakırkoy Dr. Sadi Konuk Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-01-01
Completion
2019-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04023383 on ClinicalTrials.gov