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OpenTrials
Completed

NCT Number: NCT02350790

Robotic Surgical Management of Endometriosis: Excision Versus Ablation

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic ablation

Procedure

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

Robotic excision

Procedure

Robotic excision of endometriosis

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Baseline pre-operatively

    Patients will document their pain on a VAS.

  2. Visual Analog Scale (VAS)

    Time frame: 6 months

    Patients will document their pain on a VAS.

  3. Visual Analog Scale (VAS)

    Time frame: 12 months

    Patients will document their pain on a VAS.

Secondary outcomes

  1. Quality of Life and Pain Questionnaires

    Time frame: 4 weeks,

    Patients will complete quality of life and pain questionnaires to document their responses to treatment.

  2. Quality of Life and Pain Questionnaires

    Time frame: 6 months

    Patients will complete quality of life and pain questionnaires to document their responses to treatment.

  3. Quality of Life and Pain Questionnaires

    Time frame: 12 months

    Patients will complete quality of life and pain questionnaires to document their responses to treatment.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 30, 2015
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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