Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Registrat-Mapi | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate clinically the efficacy of the PREVADH® Film in the prevention of adhesions in gynaecologic surgery, and to assess post-operative complications related to adhesions and pregnancy rate after myomectomy by open surgery.
This study was addressed to patients having an immediate or differed pregnancy desire and presenting a symptomatic or asymptomatic fibroma being able to interfere with fertility.
The primary end point was the assessment of adhesion rate to the uterine surgical sites during a laparoscopic second look performed 10 to 20 weeks post-surgery.
The secondary end points were the assessment, throughout a 3 years follow-up period, of:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevadh film | Experimental | Patient randomized in this arm have been treated with Prevadh film applied on the uterine surgical sites, at the end of the myomectomy surgery to prevent post-surgey adhesion formation. |
|
| Ringer solution | Active Comparator | Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ringer lactate solution | Other | Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Adhesions to Uterine Scars | The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy. This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand. | 10 to 20 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Fertility | Fertility was assessed by pregnancy and deliveries rates at 3 years. | 3 years |
| Adnexal Adhesions | Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980's by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| BECKER Patrice | Sofradim Production | Study Director |
| CANIS Michel, Pr | University Hospital Estaing - 63003 CLERMONT-FERRAND Cedex | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Angers | 49933 | France | |||
| Clinique du Tondu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24841647 | Derived | Canis MJ, Triopon G, Darai E, Madelenat P, LeVeque J, Panel P, Fernandez H, Audebert A, Descamps P, Castaing N, Roman H, Fauconnier A, Benifla JL. Adhesion prevention after myomectomy by laparotomy: a prospective multicenter comparative randomized single-blind study with second-look laparoscopy to assess the effectiveness of PREVADH. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:42-7. doi: 10.1016/j.ejogrb.2014.03.020. Epub 2014 Apr 8. |
Not provided
Not provided
Not provided
First patient included: 16 May 2006 Last patient included: 13 June 2008 11 participating centres, Hopsital
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prevadh™ (P) Group | Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery. |
| FG001 | Ringer Lactate™ (R) Group | Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prevadh™ (P) Group | Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati. |
| BG001 | Ringer Lactate™ (R) Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Adhesions to Uterine Scars | The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy. This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand. | Two patients in group Prevadh group were withdrawn from the study, at 1 and 6 days post-myomectomy. One patient was re-operated for compress removal in Prevadh group and was excluded. Two patients in group Lactate Ringer group were withdrawn from the study, at 1 and 6 days post-myomectomy. | Posted | Number | participants | 10 to 20 weeks post surgery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevadh™ (P) Group With Adverse Event | Patients randomized in the Prevadh group have been treated with Prevadh Film directly applied to the uterine surgical sites at the end of the myomectomy surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Achilles tendon rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Calf Pain (negative Doppler for phlebitis) | Vascular disorders | Systematic Assessment |
the surgeons were not blinded to the patients' allocation group at second-look laparoscopy.Recruitment was stopped early. 2 data analyses have been performed over the study period for primary endpoint, without any error type I adjustment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrice BECKER, Global Director, Clinical Affairs | Sofradim Production COVIDIEN | +33 4 74 08 92 38 | patrice.becker@covidien.com |
Not provided
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Prevadh film | Device | Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation. |
|
|
| 10 to 20 weeks post surgery |
| mAFS Abdominopelvic Adhesion Score | mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome). | 10 to 20 weeks post surgery |
| Bordeaux |
| 33000 |
| France |
| Béclère Hospital (Public Assistance of Paris Hospital) | Clamart | 92141 | France |
| UNIVERSITY HOSPITAL Estaing | Clermont-Ferrand | 63003 | France |
| University Carémeau Hospital | Nîmes | 30029 | France |
| TENON Hospital (Public Assistance of Paris Hospital) | Paris | 75020 | France |
| TROUSSEAU Hospital (Public Assistance of Paris Hospital) | Paris | 75571 | France |
| Bichat Hospital - Claude Bernard (Public Assistance of Paris Hospital) | Paris | 75877 | France |
| South University Hospital | Rennes | 35023 | France |
| Centre Hospitalier des quatre villes | Sèvres | 92317 | France |
| Versailles Hospital | Versailles | 78157 | France |
Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| OG001 | Ringer Lactate™ (R) Group | Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery. |
|
|
| Secondary | Fertility | Fertility was assessed by pregnancy and deliveries rates at 3 years. | Posted | Number | participants | 3 years |
|
|
|
| Secondary | Adnexal Adhesions | Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980's by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome). | Posted | Mean | Standard Deviation | units on a scale | 10 to 20 weeks post surgery |
|
|
|
| Secondary | mAFS Abdominopelvic Adhesion Score | mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome). | Posted | Mean | Standard Deviation | units on a scale | 10 to 20 weeks post surgery |
|
|
|
| 7 |
| 33 |
| 9 |
| 33 |
| EG001 | Ringer Lactate™ (R) Group With Adverse Event | Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery. . | 4 | 28 | 7 | 28 |
| Miscarriage on first quarter/SAE due to deliveries | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| ovarian hyperstimulation and in vitro fertilization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| intra-abdominal bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia due to pre- and post-operative bleeding (metrorragia) | Blood and lymphatic system disorders | Systematic Assessment |
|
| Parietal hematoma requiring Hospitalization | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Abdominal pain and digestive disorders/SAE due to deliveries | Gastrointestinal disorders | Systematic Assessment |
|
| Compress removal/Small intestine's adhesions, requiring hospitalization | Surgical and medical procedures | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | Systematic Assessment |
|
| Submucosal myoma requiring re-intervention | Reproductive system and breast disorders | Systematic Assessment |
|
| Intra-uterine polyp | Reproductive system and breast disorders | Systematic Assessment |
|
| Varicella AND Parietal hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Continuous pelvic pain AND Mild separation of the parietal scar | Reproductive system and breast disorders | Systematic Assessment |
|
| Thoracic Pain (negative angioscanner) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Superficial injury of sigmoid during coelioscopy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fever during 48-hours post-surgery | Infections and infestations | Systematic Assessment |
|
| Keloid laparoscopic scar | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hemorrhagic uterus during myomectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| 38.8°C Fever | Infections and infestations | Systematic Assessment |
|
| Submucosal myoma | Reproductive system and breast disorders | Systematic Assessment |
|
| Metrorragia due to uterine cavity opening. | Reproductive system and breast disorders | Systematic Assessment |
|
| Parietal hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Hematoma on umbilical scar | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Fever (38.5°C) | Infections and infestations | Systematic Assessment |
|
Not provided