Efficacy of Sprayable PEG Barrier in Gynecologic Laparoscopy

Radboud University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Peritoneal Adhesion, Nos; Postoperative Adhesion

Treatments: Device: Control; Device: Spraygel

Study type: Interventional

Funder types: Other

Identifiers

NCT01187680

RU-RTB-0002

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years
• Undergoing gynecologic laparoscopy

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Spraygel

Experimental group

Treatment:

Device: Spraygel

Control

Active Comparator group

Treatment:

Device: Control