Robotic Surgical Management of Endometriosis: Excision Versus Ablation

NCT ID: NCT02350790

Last Updated: 2017-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-10-31

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic ablation

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

Group Type: ACTIVE_COMPARATOR

Robotic ablation

Intervention Type: PROCEDURE

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

Robotic Excision

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

Group Type: ACTIVE_COMPARATOR

Robotic excision

Intervention Type: PROCEDURE

Robotic excision of endometriosis

Interventions

Robotic ablation

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

Intervention Type: PROCEDURE

Robotic excision

Robotic excision of endometriosis

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Timothy A Deimling

Assistant Professor, Division of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin A Riley, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16246860 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9073672 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15950657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15482763 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12923150 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 21860303 (View on PubMed)

Other Identifiers

43830

Identifier Type: -

Identifier Source: org_study_id