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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.

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.

Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.

Ringer lactate solution

Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.

Prevadh film

BECKER Patrice

CANIS Michel, Pr

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:

  * 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.

Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Efficacy and Safety of Prevadh™ in the Prevention of Adhesions in Gynaecological Surgery: a Multicenter, Randomized, French Study

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.

Fertility was assessed by pregnancy and deliveries rates at 3 years.

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 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).

Registrat-Mapi

Medtronic - MITG

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.

Prevadh™ (P) 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.

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Ringer Lactate™ (R) Group With Adverse Event

Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.

Prevadh™ (P) Group

Ringer Lactate™ (R) Group

Total

Age, Categorical

Gender

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.

Patrice BECKER, Global Director, Clinical Affairs

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.

Number of Patients With Adhesions to Uterine Scars

Pregnancy rates at 3 years

Delivery rates at 3 years

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.

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