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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Robotic Excision | Active Comparator | Half of the patients in the study will be randomized to robotic excision of endometriosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic ablation | Procedure | Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life and Pain Questionnaires | Patients will complete quality of life and pain questionnaires to document their responses to treatment. | 4 weeks, |
| Quality of Life and Pain Questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin A Riley, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16246860 | Background | 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. | |
| 9073672 | Background | 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. |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Robotic excision | Procedure | Robotic excision of endometriosis |
|
Patients will complete quality of life and pain questionnaires to document their responses to treatment.
| 6 months |
| Quality of Life and Pain Questionnaires | Patients will complete quality of life and pain questionnaires to document their responses to treatment. | 12 months |
| 15950657 | Background | 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. |
| 15482763 | Background | 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. |
| 12923150 | Background | 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. |
| 21860303 | Background | Falcone T, Lebovic DI. Clinical management of endometriosis. Obstet Gynecol. 2011 Sep;118(3):691-705. doi: 10.1097/AOG.0b013e31822adfd1. |
| D000091662 | Genital Diseases |