Clinical trial NCT02350790: Robotic Surgical Management of Endometriosis: Excision Versus Ablation
Official title: Robotic Surgical Management of Endometriosis: Excision Versus Ablation With Argon Beam Coagulator (ABC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Robotics
Laparoscopy
Endometriosis
Argon
Gynecology
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline pre-operatively
measure: Visual Analog Scale (VAS)
timeFrame: 6 months
measure: Visual Analog Scale (VAS)
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life and Pain Questionnaires
timeFrame: 4 weeks,
measure: Quality of Life and Pain Questionnaires
timeFrame: 6 months
measure: Quality of Life and Pain Questionnaires
timeFrame: 12 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kristin A Riley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Falcone T, Lebovic DI. Clinical management of endometriosis. Obstet Gynecol. 2011 Sep;118(3):691-705. doi: 10.1097/AOG.0b013e31822adfd1.