Fertility Disorders, Uterine Fibroids
Conditions
Keywords
myomectomy, adhesion prevention, pregnancy rate
Brief summary
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.
Detailed description
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: * pregnancy rate, * adverse events related to adhesions, * adnexal adhesions according to American Fertility Society score, * abdomino-pelvic adhesions according to the modified American Fertility Society score.
Interventions
Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.
DEVICEPrevadh film
Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
Sponsors
Registrat-Mapi
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic(s) or asymptomatic(s) uterin(s) fibroma(s) being able to interfere with the fertility by the patient who having an immediate or differed desire of pregnancy. * Size: diameter ≥ 6 cm at echographia (for the highest diameter) * Location interstitial and / or subserosa * planned laparotomic surgery * negative pregnancy test within 48 hours of surgery * signed inform consent
Exclusion criteria
* History of abdomino-pelvic surgery (except appendicectomy - cesarotomy) * Pre-operative embolization * Endometriosis stage \>1 (American Fertility Society classification ≥ 5) * Pregnant patient * Diabetes * Chronic corticotherapy / immuno-supressor or immuno-modulator drugs * Previous analog LH-RH drug therapy for the uterine myoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adhesions to Uterine Scars | 10 to 20 weeks post surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fertility | 3 years | Fertility was assessed by pregnancy and deliveries rates at 3 years. |
| Adnexal Adhesions | 10 to 20 weeks post surgery | 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). |
| mAFS Abdominopelvic Adhesion Score | 10 to 20 weeks post surgery | 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). |
Countries
France
Participant flow
Recruitment details
First patient included: 16 May 2006 Last patient included: 13 June 2008 11 participating centres, Hopsital
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| 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. | 28 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | Prevadh™ (P) Group | Ringer Lactate™ (R) Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 28 Participants | 61 Participants |
| Gender Female | 33 Participants | 28 Participants | 61 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 33 | 7 / 28 |
| serious Total, serious adverse events | 7 / 33 | 4 / 28 |
Outcome results
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.
Time frame: 10 to 20 weeks post surgery
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevadh™ (P) Group | Number of Patients With Adhesions to Uterine Scars | 12 participants |
| Ringer Lactate™ (R) Group | Number of Patients With Adhesions to Uterine Scars | 24 participants |
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).
Time frame: 10 to 20 weeks post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prevadh™ (P) Group | Adnexal Adhesions | 4.0 units on a scale | Standard Deviation 9.1 |
| Ringer Lactate™ (R) Group | Adnexal Adhesions | 6.3 units on a scale | Standard Deviation 12.2 |
Secondary
Fertility
Fertility was assessed by pregnancy and deliveries rates at 3 years.
Time frame: 3 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prevadh™ (P) Group | Fertility | Pregnancy rates at 3 years | 14 participants |
| Prevadh™ (P) Group | Fertility | Delivery rates at 3 years | 11 participants |
| Ringer Lactate™ (R) Group | Fertility | Pregnancy rates at 3 years | 4 participants |
| Ringer Lactate™ (R) Group | Fertility | Delivery rates at 3 years | 3 participants |
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).
Time frame: 10 to 20 weeks post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prevadh™ (P) Group | mAFS Abdominopelvic Adhesion Score | 1.6 units on a scale | Standard Deviation 2.7 |
| Ringer Lactate™ (R) Group | mAFS Abdominopelvic Adhesion Score | 2.4 units on a scale | Standard Deviation 3.5 |