Robotic Surgical Management of Endometriosis: Excision Versus Ablation

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350790
• Other study ID #: 43830
• Status: Completed
• Phase: N/A
• First received: August 20, 2013
• Last updated: January 19, 2017
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• Robotic ablation
Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC)
• Robotic excision
Robotic excision of endometriosis

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	Patients will document their pain on a VAS.	Baseline pre-operatively
Primary	Visual Analog Scale (VAS)	Patients will document their pain on a VAS.	6 months
Primary	Visual Analog Scale (VAS)	Patients will document their pain on a VAS.	12 months
Secondary	Quality of Life and Pain Questionnaires	Patients will complete quality of life and pain questionnaires to document their responses to treatment.	4 weeks,
Secondary	Quality of Life and Pain Questionnaires	Patients will complete quality of life and pain questionnaires to document their responses to treatment.	6 months
Secondary	Quality of Life and Pain Questionnaires	Patients will complete quality of life and pain questionnaires to document their responses to treatment.	12 months