NCT02350790

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 20, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

August 20, 2013

Last Update Submit

January 19, 2017

Conditions

Endometriosis

Keywords

RoboticsLaparoscopyEndometriosisArgonGynecology

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale (VAS)

    Patients will document their pain on a VAS.

    Baseline pre-operatively

  • Visual Analog Scale (VAS)

    Patients will document their pain on a VAS.

    6 months

  • Visual Analog Scale (VAS)

    Patients will document their pain on a VAS.

    12 months

Secondary Outcomes (3)

  • Quality of Life and Pain Questionnaires

    4 weeks,

  • Quality of Life and Pain Questionnaires

    6 months

  • Quality of Life and Pain Questionnaires

    12 months

Study Arms (2)

Robotic ablation

ACTIVE COMPARATOR

Half of the patients in the study will be randomized to robotic ablation of endometriosis with the argon beam coagulator (ABC).

Procedure: Robotic ablation

Robotic Excision

ACTIVE COMPARATOR

Half of the patients in the study will be randomized to robotic excision of endometriosis.

Procedure: Robotic excision

Interventions

Robotic ablationPROCEDURE

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

Robotic ablation
Robotic excisionPROCEDURE

Robotic excision of endometriosis

Robotic Excision

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endometriosis
  • Chronic Pelvic Pain
  • Stage 1-3 Endometriosis
  • Reproductive aged women

You may not qualify if:

  • Stage 4 Endometriosis
  • Deeply Infiltrating Endometriosis
  • Patients who decline surgical management of endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (6)

  • Hart R, Hickey M, Maouris P, Buckett W, Garry R. Excisional surgery versus ablative surgery for ovarian endometriomata: a Cochrane Review. Hum Reprod. 2005 Nov;20(11):3000-7. doi: 10.1093/humrep/dei207.

    PMID: 16246860BACKGROUND

  • Daniell JF, McTavish G, Kurtz BR, Tallab F. Laparoscopic Use of Argon Beam Coagulator in the Management of Endometriosis. J Am Assoc Gynecol Laparosc. 1994 Aug;1(4, Part 2):S9. doi: 10.1016/s1074-3804(05)80894-1.

    PMID: 9073672BACKGROUND

  • Wright J, Lotfallah H, Jones K, Lovell D. A randomized trial of excision versus ablation for mild endometriosis. Fertil Steril. 2005 Jun;83(6):1830-6. doi: 10.1016/j.fertnstert.2004.11.066.

    PMID: 15950657BACKGROUND

  • Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. Fertil Steril. 2004 Oct;82(4):878-84. doi: 10.1016/j.fertnstert.2004.03.046.

    PMID: 15482763BACKGROUND

  • Abbott JA, Hawe J, Clayton RD, Garry R. The effects and effectiveness of laparoscopic excision of endometriosis: a prospective study with 2-5 year follow-up. Hum Reprod. 2003 Sep;18(9):1922-7. doi: 10.1093/humrep/deg275.

    PMID: 12923150BACKGROUND

  • Falcone T, Lebovic DI. Clinical management of endometriosis. Obstet Gynecol. 2011 Sep;118(3):691-705. doi: 10.1097/AOG.0b013e31822adfd1.

    PMID: 21860303BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Kristin A Riley, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Division of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 20, 2013

First Posted

January 30, 2015

Study Start

December 1, 2013

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

US(1)