New Cross Linked Hyaluronan Gel After Deep Infiltrating Endometriosis Surgery

NCT04023383 | Completed

• 1 other identifier: HYALOENDOQoL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• The preoperative and postoperative 3rd and 6th month change of Visual Analogue Scale symptom score

  A validated form of VAS score was used and scored from 0: No pain to 10: the worst pain all in their lives in a likert fashion.

  The preoperative and postoperative 6th month change in Visual Analogue Scale symptom score

Secondary Outcomes (2)

• Short Form-12 Quality of Life

  The preoperative and postoperative 3rd and 6th month change of Short Form-12 Quality of Life questions were recorded considering follow up visits.

• Endometriosis Health Profile (EHP-5)

  The preoperative and postoperative 3rd and 6th month change of A validated form of

Study Arms (2)

Control

PLACEBO COMPARATOR

The patients in the control group had 40 cc sterile saline solution compatible with the body temperature.

Drug: 40 cc sterile saline solution

HyaRegen NCH gel group

EXPERIMENTAL

In the intervention group had 40 mL of HyaRegen NCH gel instilled into the peritoneal cavity through a large-bore cannula following standard laparoscopic procedures.

Drug: 40 cc HyaRegen NCH gel

Interventions

40 cc HyaRegen NCH gel DRUG

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

Also known as: bleeding control

HyaRegen NCH gel group

40 cc sterile saline solution DRUG

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

Also known as: bleeding control

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18 to 45 years
• undergoing laparoscopic surgery for suspicious of DIE
• persistent pain irrespective to any medical treatment

You may not qualify if:

• acute or severe infection
• autoimmune disease
• known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives
• concurrent use of a systemic anti-inflammatory or hormonal drug at least 3 months prior to the surgery
• clinical evidence of cancer
• use of anticoagulant, fibrin glue, other thromboembolic agents
• use of any other anti-adhesion agent during the procedure
• patients with surgically diagnosed bowel involvement or need bowel resection
• patients who want to receive any postoperative hormonal treatment

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Related Publications (1)

• Arcoverde FVL, Andres MP, Borrelli GM, Barbosa PA, Abrao MS, Kho RM. Surgery for Endometriosis Improves Major Domains of Quality of Life: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Feb;26(2):266-278. doi: 10.1016/j.jmig.2018.09.774. Epub 2018 Sep 20.

  PMID: 30244153 RESULT

MeSH Terms

Conditions

Endometriosis; Tissue Adhesions

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Murat Ekin, MD

  Bakırkoy Dr. Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 17, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share