Trial Outcomes & Findings for Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery (NCT NCT01388907)

Last Updated: 2016-11-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

61 participants

Primary outcome timeframe

10 to 20 weeks post surgery

Results posted on

2016-11-17

Participant Flow

First patient included: 16 May 2006 Last patient included: 13 June 2008 11 participating centres, Hopsital

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	33	28
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Adverse Event	2	0

Baseline Characteristics

Efficacity Assessment of PREVADH® in Adhesion Prevention in Gynaecologic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prevadh™ (P) Group n=33 Participants Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.	Ringer Lactate™ (R) Group n=28 Participants 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.	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Female	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Prevadh™ (P) Group n=28 Participants Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.	Ringer Lactate™ (R) Group n=26 Participants 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.
Number of Patients With Adhesions to Uterine Scars	12 participants	24 participants

SECONDARY outcome

Timeframe: 3 years

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

Outcome measures

Outcome measures
Measure	Prevadh™ (P) Group n=28 Participants Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.	Ringer Lactate™ (R) Group n=26 Participants 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.
Fertility Pregnancy rates at 3 years	14 participants	4 participants
Fertility Delivery rates at 3 years	11 participants	3 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Prevadh™ (P) Group n=28 Participants Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.	Ringer Lactate™ (R) Group n=26 Participants 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.
Adnexal Adhesions	4.0 units on a scale Standard Deviation 9.1	6.3 units on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Prevadh™ (P) Group n=28 Participants Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.	Ringer Lactate™ (R) Group n=26 Participants 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.
mAFS Abdominopelvic Adhesion Score	1.6 units on a scale Standard Deviation 2.7	2.4 units on a scale Standard Deviation 3.5

Adverse Events

Prevadh™ (P) Group With Adverse Event

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Ringer Lactate™ (R) Group With Adverse Event

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prevadh™ (P) Group With Adverse Event n=33 participants at risk 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.	Ringer Lactate™ (R) Group With Adverse Event n=28 participants at risk 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. .
Musculoskeletal and connective tissue disorders Achilles tendon rupture	0.00% 0/33	3.6% 1/28 • Number of events 1
Pregnancy, puerperium and perinatal conditions Miscarriage on first quarter/SAE due to deliveries	3.0% 1/33 • Number of events 1	0.00% 0/28
Pregnancy, puerperium and perinatal conditions ovarian hyperstimulation and in vitro fertilization	3.0% 1/33 • Number of events 1	0.00% 0/28
Blood and lymphatic system disorders intra-abdominal bleeding	3.0% 1/33 • Number of events 1	0.00% 0/28
Blood and lymphatic system disorders Anemia due to pre- and post-operative bleeding (metrorragia)	3.0% 1/33 • Number of events 1	0.00% 0/28
Skin and subcutaneous tissue disorders Parietal hematoma requiring Hospitalization	3.0% 1/33 • Number of events 1	0.00% 0/28
Gastrointestinal disorders Abdominal pain and digestive disorders/SAE due to deliveries	3.0% 1/33 • Number of events 1	0.00% 0/28
Surgical and medical procedures Compress removal/Small intestine's adhesions, requiring hospitalization	3.0% 1/33 • Number of events 1	0.00% 0/28
Immune system disorders Anaphylactic shock	0.00% 0/33	3.6% 1/28 • Number of events 1
Reproductive system and breast disorders Submucosal myoma requiring re-intervention	0.00% 0/33	3.6% 1/28 • Number of events 1
Reproductive system and breast disorders Intra-uterine polyp	0.00% 0/33	3.6% 1/28 • Number of events 1

Other adverse events

Other adverse events
Measure	Prevadh™ (P) Group With Adverse Event n=33 participants at risk 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.	Ringer Lactate™ (R) Group With Adverse Event n=28 participants at risk 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. .
Vascular disorders Calf Pain (negative Doppler for phlebitis)	3.0% 1/33 • Number of events 1	0.00% 0/28
Skin and subcutaneous tissue disorders Varicella AND Parietal hematoma	3.0% 1/33 • Number of events 1	0.00% 0/28
Reproductive system and breast disorders Continuous pelvic pain AND Mild separation of the parietal scar	3.0% 1/33 • Number of events 1	0.00% 0/28
Respiratory, thoracic and mediastinal disorders Thoracic Pain (negative angioscanner)	3.0% 1/33 • Number of events 1	0.00% 0/28
Injury, poisoning and procedural complications Superficial injury of sigmoid during coelioscopy	0.00% 0/33	3.6% 1/28 • Number of events 1
Infections and infestations Fever during 48-hours post-surgery	0.00% 0/33	3.6% 1/28 • Number of events 1
Injury, poisoning and procedural complications Keloid laparoscopic scar	3.0% 1/33 • Number of events 1	0.00% 0/28
Reproductive system and breast disorders Hemorrhagic uterus during myomectomy	0.00% 0/33	3.6% 1/28 • Number of events 1
Infections and infestations 38.8°C Fever	3.0% 1/33 • Number of events 1	0.00% 0/28
Reproductive system and breast disorders Submucosal myoma	3.0% 1/33 • Number of events 1	3.6% 1/28 • Number of events 1
Reproductive system and breast disorders Metrorragia due to uterine cavity opening.	0.00% 0/33	3.6% 1/28 • Number of events 1
Skin and subcutaneous tissue disorders Parietal hematoma	3.0% 1/33 • Number of events 1	3.6% 1/28 • Number of events 1
Gastrointestinal disorders Abdominal pain	3.0% 1/33 • Number of events 1	0.00% 0/28
Skin and subcutaneous tissue disorders Hematoma on umbilical scar	0.00% 0/33	3.6% 1/28 • Number of events 1
Infections and infestations Fever (38.5°C)	3.0% 1/33 • Number of events 1	0.00% 0/28

Additional Information

Patrice BECKER, Global Director, Clinical Affairs

Sofradim Production COVIDIEN

Phone: +33 4 74 08 92 38

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60