Robotic Surgical Management of Endometriosis: Excision Versus Ablation

Robotic Surgical Management of Endometriosis: Excision Versus Ablation With Argon Beam Coagulator (ABC)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02350790

Enrollment

Registered

2015-01-30

Start date

2013-12-31

Completion date

2015-10-31

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Robotics, Laparoscopy, Endometriosis, Argon, Gynecology

Brief 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.

Detailed 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.

Interventions

PROCEDURERobotic ablation

Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC)

PROCEDURERobotic excision

Robotic excision of endometriosis

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Analog Scale (VAS)	Baseline pre-operatively	Patients will document their pain on a VAS.

Secondary

Measure	Time frame	Description
Quality of Life and Pain Questionnaires	4 weeks,	Patients will complete quality of life and pain questionnaires to document their responses to treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026