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| ID | Type | Description | Link |
|---|---|---|---|
| RC1EB010649-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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The purpose of this research is to determine if there is a difference in total costs of care and return to health in women who undergo a laparoscopic abdominal sacrocolpopexy (ASC) compared to those undergoing the same procedure with the assistance of a robot.
Both traditional laparoscopic and robotic assisted laparoscopic approaches have been found to result in shorter hospital stays, decreased blood loss and similar surgical outcomes as compared to open abdominal surgery. The decision to use robotic assistance is typically based on surgeon preference and robot availability. The study will compare the outcomes of cost, quality of life, and return to work among women who undergo a laparoscopic sacrocolpopexy utilizing the robot to those using traditional laparoscopic techniques.
This research study is designed to compare the total costs and treatment success of these two surgical techniques. In addition, the study will compare outcomes of post-operative pain, quality of life, sexual function, return to normal activities and satisfaction with treatment outcome.
Approximately one in ten women undergoes surgery for prolapse or incontinence in her lifetime. Of these, up to thirty percent require a re-operation for recurrence of their prolapse or incontinence symptoms. It has been estimated one in nine women will undergo a hysterectomy in her lifetime, and up to 10% of these women will require surgery for symptomatic vaginal vault prolapse. The search for the ideal repair for pelvic organ prolapse has led to the invention of several approaches to this problem.
Abdominal sacrocolpopexy (ASC) with synthetic mesh is considered the gold standard in the surgical management of pelvic organ prolapse with anatomic success rates ranging from 90 to 100%. Randomized comparative effectiveness trials and systematic literature reviews demonstrated the anatomic superiority of open ASC compared to vaginal sacrospinous ligament suspension.
Although ASC has the highest anatomic success rates for correcting apical prolapse, it is traditionally done via a laparotomy requiring an abdominal incision. Open technique is associated with more frequent short-term complications, including gastrointestinal.
Minimally invasive approaches to ASC using laparoscopy or robotic assisted laparoscopy demonstrate shorter hospital stays, decreased blood loss, and similar short-term anatomic outcomes when compared to open ASC. Increasing numbers of surgeons and patients choose minimally invasive ASC to maximize the benefits of abdominal placed mesh and the shorter-recovery associated with minimally invasive surgery. Few studies have compared laparoscopy to robotic assisted-laparoscopy in pelvic reconstructive surgery.
Like many techniques in pelvic surgery, trends in the management of pelvic organ prolapse continue to evolve. Unfortunately, such trends are not supported by robust data, specifically that provided by randomized clinical trials. Although robotic technology is new and rapidly spreading throughout the urologic and gynecologic communities, there are no randomized trials comparing outcomes of robotic to more traditional laparoscopic techniques for reconstructive pelvic surgery. Retrospective series indicate comparable efficacy with respect to cure of prolapse. However, to date is it unknown how robotic surgery compares to laparoscopic techniques with respect to cost, patient safety, pain, and ability to return to normal activities.
The use of the robot in laparoscopic surgery is costly. The costs of purchasing a robot has been estimated at $1.5 million dollars with annual maintenance costs of $112,0007. In addition, additional costs exist for the robotic equipment utilized with each case. It is arguable that the maintenance and operative equipment costs may overshadow any potential savings in length of hospital stay and patient convalescence. However, if robotic sacrocolpopexy can provide better immediate quality of life, less pain, and faster recovery compared to laparoscopic techniques, the investment in robotic techniques may very well be cost effective when a societal perspective is taken.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Abdominal Sacrocolpopexy (LASC) | Active Comparator | Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) |
|
| Robotic Assisted Laparoscopic (RASC) | Experimental | Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic assisted laparoscopic abdominal sacrocolpopexy | Procedure | Robotic assisted laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy | At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy | At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Kenton, M.D. | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| Loyola University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20025020 | Background | Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. doi: 10.1002/nau.20870. No abstract available. | |
| 15458906 |
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Following enrollment, six women withdrew prior to randomization and two women were lost to follow-up prior to randomization
The recruitment period was from November 2009 to August 2011 (21 months)
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| ID | Title | Description |
|---|---|---|
| FG000 | Laparoscopic Abdominal Sacrocolpopexy (LASC) | Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) |
| FG001 | Robotic Assisted Laparoscopic (RASC) | Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population comprises all randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Laparoscopic Abdominal Sacrocolpopexy (LASC) | Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) |
| BG001 | Robotic Assisted Laparoscopic (RASC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Cost of Care Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy | At 6-weeks following surgery, the study will measure the total cost of care in dollars and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. | The analysis for the primary outcome includes all randomized subjects. | Posted | Mean | Standard Deviation | Dollars | 6 Weeks |
|
Adverse event data were collected for 1 year, 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laparoscopic Abdominal Sacrocolpopexy (LASC) | Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mesh Exposure | Surgical and medical procedures | Non-systematic Assessment | Suburethral Sling Mesh Exposure |
There are no limitations or caveats to specify.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Mueller, M.D. | Loyola University | 708-216-2180 | emuelle@lumc.edu |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Standard laparoscopic abdominal sacrocolpopexy | Procedure | Standard laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse. |
|
|
| 6 Months |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Background |
| Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. doi: 10.1097/01.AOG.0000139514.90897.07. |
| 8987919 | Background | Benson JT, Lucente V, McClellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol. 1996 Dec;175(6):1418-21; discussion 1421-2. doi: 10.1016/s0002-9378(96)70084-4. |
| 14749629 | Background | Maher CF, Qatawneh AM, Dwyer PL, Carey MP, Cornish A, Schluter PJ. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol. 2004 Jan;190(1):20-6. doi: 10.1016/j.ajog.2003.08.031. |
| 19932417 | Background | McDermott CD, Hale DS. Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):585-614. doi: 10.1016/j.ogc.2009.09.004. |
| 20818872 | Background | Barbash GI, Glied SA. New technology and health care costs--the case of robot-assisted surgery. N Engl J Med. 2010 Aug 19;363(8):701-4. doi: 10.1056/NEJMp1006602. No abstract available. |
| 20547112 | Background | Holtz DO, Miroshnichenko G, Finnegan MO, Chernick M, Dunton CJ. Endometrial cancer surgery costs: robot vs laparoscopy. J Minim Invasive Gynecol. 2010 Jul-Aug;17(4):500-3. doi: 10.1016/j.jmig.2010.03.012. Epub 2010 May 23. |
| 20207063 | Background | Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5. |
| 21979458 | Background | Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c. |
| 18923803 | Background | Patel M, O'Sullivan D, Tulikangas PK. A comparison of costs for abdominal, laparoscopic, and robot-assisted sacral colpopexy. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):223-8. doi: 10.1007/s00192-008-0744-2. Epub 2008 Oct 16. |
| 7971299 | Background | Brink CA, Wells TJ, Sampselle CM, Taillie ER, Mayer R. A digital test for pelvic muscle strength in women with urinary incontinence. Nurs Res. 1994 Nov-Dec;43(6):352-6. |
| 1593914 | Background | Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. |
| 15725977 | Background | Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005 Mar;43(3):203-20. doi: 10.1097/00005650-200503000-00003. |
| 16647933 | Background | Barber MD, Walters MD, Cundiff GW; PESSRI Trial Group. Responsiveness of the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) in women undergoing vaginal surgery and pessary treatment for pelvic organ prolapse. Am J Obstet Gynecol. 2006 May;194(5):1492-8. doi: 10.1016/j.ajog.2006.01.076. |
| 11262452 | Background | Rogers RG, Kammerer-Doak D, Villarreal A, Coates K, Qualls C. A new instrument to measure sexual function in women with urinary incontinence or pelvic organ prolapse. Am J Obstet Gynecol. 2001 Mar;184(4):552-8. doi: 10.1067/mob.2001.111100. |
| 18574712 | Background | Hollenbeck BK, Dunn RL, Wolf JS Jr, Sanda MG, Wood DP, Gilbert SM, Weizer AZ, Montie JE, Wei JT. Development and validation of the convalescence and recovery evaluation (CARE) for measuring quality of life after surgery. Qual Life Res. 2008 Aug;17(6):915-26. doi: 10.1007/s11136-008-9366-x. Epub 2008 Jun 24. |
| 19661099 | Background | Hedgepeth RC, Wolf JS Jr, Dunn RL, Wei JT, Hollenbeck BK. Patient-reported recovery after abdominal and pelvic surgery using the Convalescence and Recovery Evaluation (CARE): implications for measuring the impact of surgical processes of care and innovation. Surg Innov. 2009 Sep;16(3):243-8. doi: 10.1177/1553350609342075. Epub 2009 Aug 5. |
| 18090752 | Background | Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10. |
| 16647928 | Background | Jelovsek JE, Barber MD. Women seeking treatment for advanced pelvic organ prolapse have decreased body image and quality of life. Am J Obstet Gynecol. 2006 May;194(5):1455-61. doi: 10.1016/j.ajog.2006.01.060. |
| 16611949 | Background | Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208. |
| 20479459 | Background | Richter HE, Albo ME, Zyczynski HM, Kenton K, Norton PA, Sirls LT, Kraus SR, Chai TC, Lemack GE, Dandreo KJ, Varner RE, Menefee S, Ghetti C, Brubaker L, Nygaard I, Khandwala S, Rozanski TA, Johnson H, Schaffer J, Stoddard AM, Holley RL, Nager CW, Moalli P, Mueller E, Arisco AM, Corton M, Tennstedt S, Chang TD, Gormley EA, Litman HJ; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010 Jun 3;362(22):2066-76. doi: 10.1056/NEJMoa0912658. Epub 2010 May 17. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 19638912 | Background | Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. |
| 15497198 | Background | Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944. |
| 27403758 | Derived | Kenton K, Mueller ER, Tarney C, Bresee C, Anger JT. One-Year Outcomes After Minimally Invasive Sacrocolpopexy. Female Pelvic Med Reconstr Surg. 2016 Sep-Oct;22(5):382-4. doi: 10.1097/SPV.0000000000000300. |
| 27180224 | Derived | Mueller ER, Kenton K, Anger JT, Bresee C, Tarnay C. Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):917-21. doi: 10.1016/j.jmig.2016.05.001. Epub 2016 May 12. |
| 24463657 | Derived | Anger JT, Mueller ER, Tarnay C, Smith B, Stroupe K, Rosenman A, Brubaker L, Bresee C, Kenton K. Robotic compared with laparoscopic sacrocolpopexy: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):5-12. doi: 10.1097/AOG.0000000000000006. |
Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| City and state where the study activities took place | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Parity | Mean | Standard Deviation | Count of pregnancies |
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| Years of Education | Count of Participants | Participants |
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| Net household income | Count of Participants | Participants |
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| Comorbid Diabetes | Count of Participants | Participants |
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| History of Heart Attack | Count of Participants | Participants |
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| History of Stroke | Count of Participants | Participants |
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| History of Cancer | Count of Participants | Participants |
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| History of Stomach Ulcer | Count of Participants | Participants |
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| Postmenopausal | Count of Participants | Participants |
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| Concomitant estrogen therapy | Count of Participants | Participants |
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| Previous surgery for urinary incontinence | Count of Participants | Participants |
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| Previous surgery for pelvic organ prolapse | Count of Participants | Participants |
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| Prior Hysterectomy | Count of Participants | Participants |
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| Secondary | Urinary Distress Between Standard and Robotic-assisted Laparoscopic Abdominal Sacrocolpopexy | At 6-months following surgery, the study will measure urinary distress using the Urinary Distress Inventory (UDI) and compare this estimate between women assigned to standard vs robotic-assisted laparoscopic abdominal sacrocolpopexy. The UDI measures urinary incontinence and distress and their effect on daily life. The score range is 0 to 300, with higher scores indicating worsening symptoms. | The analysis excludes three individuals assigned to the LASC cohort and two individuals assigned to the RASC cohort because they were lost to follow-up six months after intervention. | Posted | Mean | Standard Deviation | units on a scale | 6 Months |
|
|
|
|
| 0 |
| 38 |
| 8 |
| 38 |
| EG001 | Robotic Assisted Laparoscopic (RASC) | Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC) | 0 | 40 | 7 | 40 |
|
| Illiac Vein Injury | Surgical and medical procedures | Non-systematic Assessment | Left Iliac Vein Injury occurred at the time of the presacral dissection |
|
| Diverticulitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Incarcerated Hernia | Gastrointestinal disorders | Non-systematic Assessment |
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| Tissue granulation | Reproductive system and breast disorders | Non-systematic Assessment | Granulation of tissue was noted in the posterior midline of the vagina |
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| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Mallory-Weiss tear | Gastrointestinal disorders | Non-systematic Assessment |
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| Dyspnea | General disorders | Non-systematic Assessment |
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| Intraoperative cystotomy | Surgical and medical procedures | Non-systematic Assessment | While passing the trocar, an Intraoperative Cystotomy was encountered. This was immediately identified by Cystoscopy and removed |
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| Bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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