Symptoms and General Pathology

All Conditions

Neoplasms

Tissue Adhesions

Myoma

Cicatrix

Fibrosis

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Pharmaceutical Solutions

All Drugs and Chemicals

Standard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure)

A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.

Adhibit Adhesion Prevention Gel

standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure

Standard of Care Comparator

Liselotte METTLE, MD, PhD

The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas

Postoperative adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.

Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation

A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery

Angiotech Pharmaceuticals

Hematinics

Liver Extracts

Patients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.

Patients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.

Liver resection performed for metastatic disease from colorectal carcinoma

Liver resection

Harry P van Goor, MD, PhD

Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.

Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases.

Study design: The study is designed as a prospective observational cohort study.

Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.

Main study parameters/endpoints:

* Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision.
* Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose.

Adhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients.

Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection

Patient has episode of small bowel obstruction in medical history

To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.

Inadvertent bowel injury made during operation

Incidence of predetermined postoperative complications:

* mortality
* incisional wound infection
* abdominal sepsis
* pneumonia
* urinary tract infection

Radboud University Medical Center

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective Tissue

Connective Tissue Diseases

Anticonvulsants

Central Nervous System Depressants

Zaleplon

Intrauterine ultrasound guided radio-frequency ablation

Radiofrequency ablation for the treatment of uterine fibroids

This study is designed to observe the presence or absence of intrauterine adhesions at 6 weeks after treatment with the Sonata® System through hysteroscopic evaluation by third party readers.

Patients who agree to participate in this observational trial will have selected fibroid treatment with the Sonata System. Research participants will undergo hysteroscopy at 6 weeks following treatment to evaluate presence or absence of intrauterine adhesions.

Research participants will be asked to complete a quality of life questionnaire prior to and 6 weeks following treatment. Research participants will also complete a satisfaction survey and a diary that tracks their return to normal daily activities.

Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids

This observational study is intended to view the group as an entirety, individual participant data will be analyzed for adhesions but will not be shared independently.

Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.

As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.

Gynesonics

Intrauterine ultrasound guided radio-frequency ablation

Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids

Fibroid Treatment

Intrauterine ultrasound guided radio-frequency ablation Intrauterine ultrasound guided radio-frequency ablation: Radiofrequency ablation for the treatment of uterine fibroids

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Taraneh G. Farazi, Ph.D. (Vice President, Clinical Affairs)

Participants with completed follow-up assessment and had evaluable hysteroscopy videos.

Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids

Participants who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.

Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Endometriosis

Cysts

Ovarian Cysts

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Endocrine System Diseases

patients who will be treated in accordance with standard of care

patients for which Adhexil will be applied to prevent/reduce adhesions

ADHEXIL

Eran Kurman, B.med.Sc, MBA

The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.

Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery

A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery

OMRIX Biopharmaceuticals

Eran Kurman, Clinical Affairs Manager

Rare Diseases

Pathological Conditions, Anatomical

Oculocerebral Syndrome With Hypopigmentation

Hyaluronic Acid

Adjuvants, Immunologic

Immunologic Factors

Viscosupplements

Protective Agents

Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery

Saline

Cross-linked Hyaluronan Hydrogel

Zhenyu Zhang, MD, PhD

The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery

Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.

The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions

The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial

The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.

modified American Fertility Society (mAFS) score of ovaries/tubes

The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points.

modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity)

Adhesion extent (throughout abdominopelvic cavity)

Adhesion severity (throughout abdominopelvic cavity)

Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc.

BioRegen Biomedical (CHangzhou) Co., Ltd

Infertility

Laparoscopic surgery utilizing V-Loc suture

V-Loc suture will be utilized in the repair of the uterus following removal of fibroid tumors. a second look laparoscopy will be done on all subjects to evaluate scar tissue formation.

surgery utilizing V-Loc suture

Charles E Miller, MD

Premenopausal Women ages 18-42 will undergo a laparoscopic myomectomy. Prior to the myomectomy, adhesions will be assessed using a modified AFS scoring technique. All investigators will provide usual and customary care to research subjects during the first look laparoscopy. This includes the use of all standard practice anti-adhesive agents and heparinized irrigation fluids.V-Loc 180 suture will be utilized in all patients. All patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and reevaluated via modified American Fertility Society scoring techniques. An independent reviewer will also score adhesions utilize a video recording made from the second look laparoscopic surgery. Patients will be contacted both 1 and 4 weeks post -op and assessed for complications. It is the expectation that patients will show no greater post-operative adhesion formation and a \<1% complication rate. Time and ease of suturing will also be evaluated. It is expected that the V-Loc suturing technique will show significantly reduced suturing time, be easier to use, and will be associated with minimal adhesions.

This is a post-market, controlled, single-center study to evaluate V-Loc suture. 10 subjects will be included in this study. Premenopausal women ages 18-42 will undergo a laparoscopic myomectomy. Adhesion scoring will be done prior to the myomectomy using a modified American Fertility Society scoring technique. V-loc 180 suture will be utilized in all patients for closure of all uterine defects. All patients will then be evaluated by means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and evaluated via modified American Fertility Society scoring techniques.

An independent reviewer will also score adhesions utilizing video recordings made from the second look laparoscopic surgery , using the same scoring techniques employed by the PI..

Patients will undergo routine preoperative blood tests in accordance with the Primary Investigators' usual standard of practice. All patients who meet the inclusion criteria will be considered. Patients will be consented prior to entry into the operating room. Surgical time will be measured from start of procedure, start of myomectomy, and start and finish time of each individual uterine closure. All investigators will provide usual and customary care to research subjects during the first look laparoscopy. This includes the use of all standard practice anti-adhesive agents and heparinized irrigation fluids

. Physicians will be surveyed on ease of use and any problems that occur with V-Loc suture.

All patients will be treated with post-operative antibiotics per the Primary Investigator's usual standard of care. Patients will be contacted both one and 4 weeks post surgery and evaluated for complications using a phone survey for pain and bowel functioning. The patient will also have a standard post operative exam with the physician 4-6 weeks post-operatively. A second look laparoscopy will be performed 6-12 weeks following the initial myomectomy. Adhesions will be evaluated using a modified American Fertility Society evaluation tool. Any adhesions seen at the time of SLL will be treated using the physician's preferred method of adhesiolysis. A recording will be obtained of the second look laparoscopy and will be reviewed and scored by an independent reviewer as to the level of adhesions seen .

a Study to Evaluate Adhesion Risk in Fertility Patients' Status Post Laparoscopic Myomectomy.

A Case Study to Evaluate Adhesion Risk in Fertility Patients' Post Laparoscopic Myomectomy Utilizing Vloc Suture.

The primary objective of this study is to evaluate post operative adhesion formation after using V-Loc™ 180 during laparoscopic myomectomy.

The time required to close the incision as well as the ease of use to the surgeon will be measured .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation	NCT00562471	Myoma	Adhibit Adhesio... Standard of Car...	18 Years -	Angiotech Pharmaceuticals
Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection	NCT01720966	Adhesions	Liver resection	18 Years - 100 Years	Radboud University Medical Center
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids	NCT02844920	Uterine Fibroid... Adhesions	Intrauterine ul...	18 Years -	Gynesonics
Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery	NCT00865488	Ovarian Cysts Endometriosis Adhesions	ADHEXIL	18 Years - 45 Years	OMRIX Biopharmaceuticals
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions	NCT02166554	Myomas Ovary Cysts Endometriotic C... Adhesions	Saline Cross-linked Hy...	18 Years - 45 Years	BioRegen Biomedical (CHangzhou) Co., Ltd
a Study to Evaluate Adhesion Risk in Fertility Patients' Status Post Laparoscopic Myomectomy.	NCT01971060	Uterine Fibroid... Infertility	surgery utilizi...	18 Years - 42 Years	The Advanced Gynecologic Surgery Institute
Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids	NCT02844920	Uterine Fibroid... Adhesions	Intrauterine ul...	18 Years -	Gynesonics

Spots Global Cancer Trial Database for adhesions

Every month we try and update this database with for adhesions cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for adhesions

Every month we try and update this database with for adhesions cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for adhesions cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.