Overview

This trial is active, not recruiting.

Condition endometriosis
Treatments robotic ablation, robotic excision
Sponsor Milton S. Hershey Medical Center
Start date December 2013
End date July 2015
Trial size 100 participants
Trial identifier NCT02350790, 43830

Summary

Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned to either ablation or excision of endometriosis. The investigators think that patients who have excision of endometriosis will have greater relief of pain.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Half of the patients in the study will be randomized to robotic ablation of endometriosis with the argon beam coagulator (ABC).
robotic ablation
Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC)
(Active Comparator)
Half of the patients in the study will be randomized to robotic excision of endometriosis.
robotic excision
Robotic excision of endometriosis

Primary Outcomes

Measure
Visual Analog Scale (VAS)
time frame: Baseline pre-operatively
Visual Analog Scale (VAS)
time frame: 6 months
Visual Analog Scale (VAS)
time frame: 12 months

Secondary Outcomes

Measure
Quality of Life and Pain Questionnaires
time frame: 4 weeks,
Quality of Life and Pain Questionnaires
time frame: 6 months
Quality of Life and Pain Questionnaires
time frame: 12 months

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Inclusion Criteria: - Endometriosis - Chronic Pelvic Pain - Stage 1-3 Endometriosis - Reproductive aged women Exclusion Criteria: - Stage 4 Endometriosis - Deeply Infiltrating Endometriosis - Patients who decline surgical management of endometriosis

Additional Information

Official title Robotic Surgical Management of Endometriosis: Excision Versus Ablation With Argon Beam Coagulator (ABC)
Principal investigator Kristin A Riley, MD
Description Patients with known endometriosis based on prior surgical pathology or suspected endometriosis based on symptomatology who plan on undergoing diagnostic laparoscopy will be offered enrollment in the study. They will complete preoperative pain assessments with the tools outlined above. At the time of diagnostic laparoscopy, patients found to have endometriosis will be staged according to the American Society of Reproductive Medicine guidelines. Patients with Stage 4 or deeply infiltrating endometriosis will be excluded from the study. At that point, the patients will be randomized in the operating room to either laparoscopic excision of endometriosis or laparoscopic ablation with the argon beam coagulator. Patients will be stratified according to the presence or absence of the Levonorgestrel-Intrauterine Device. Pain assessments will be performed immediately postoperatively in the recovery area. Pain assessments will again be performed at 4 weeks, 6 months and 12 months. We will use the VAS pain scale and validated questionnaires.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.