NCT01187680

Brief Summary

The purpose of the study is to investigate whether sprayable PEG barrier is effective in reducing adhesions in laparoscopic gynecologic surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
Last Updated

December 29, 2010

Status Verified

August 1, 2010

Enrollment Period

1.5 years

First QC Date

July 19, 2010

Last Update Submit

December 28, 2010

Conditions

Postoperative AdhesionPeritoneal Adhesion, Nos

Keywords

Tissue adhesionsLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • successful adhesion prevention

    Adhesion prevention was defined as successful if no de novo fromed adhesion were found at second look laparoscopy.

Secondary Outcomes (2)

  • LABS adhesion score

  • Adhesion sites

Study Arms (2)

Spraygel

EXPERIMENTAL
Device: Spraygel

Control

ACTIVE COMPARATOR
Device: Control

Interventions

SpraygelDEVICE
Spraygel
ControlDEVICE

Good surgical technique, no adhesion barrier

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \>18 years
  • Undergoing gynecologic laparoscopy

You may not qualify if:

  • Suspected malignancy
  • Incomplete adhesiolysis during initial laparoscopy
  • Pregnancy
  • Lactating
  • Stage IV endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Location

MeSH Terms

Conditions

Pyloric Stenosis, HypertrophicTissue Adhesions

Condition Hierarchy (Ancestors)

Pyloric StenosisGastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 19, 2010

First Posted

August 24, 2010

Study Start

October 1, 2002

Primary Completion

April 1, 2004

Study Completion

July 1, 2009

Last Updated

December 29, 2010

Record last verified: 2010-08

Locations

NL(1)