Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Laparoscopic Surgery
NCT ID: NCT04064216
Last Updated: 2020-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2019-07-16
2020-03-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Robot assisted laparoscopic surgery
This group will be consisted of patients that will undergo robot assisted laparoscopic surgery for benign gynecologic disorders
Laparoscopic surgery
Patients that will undergo robot assisted laparoscopic surgery and conventional laparoscopic surgery for benign gynecologic disorders will answer 4 questionnaires to assess patient satisfaction, quality of life and cosmesis
Conventional laparoscopic surgery
This group will be consisted of patients that will undergo conventional laparoscopic surgery for benign gynecologic disorders
Laparoscopic surgery
Patients that will undergo robot assisted laparoscopic surgery and conventional laparoscopic surgery for benign gynecologic disorders will answer 4 questionnaires to assess patient satisfaction, quality of life and cosmesis
Interventions
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Laparoscopic surgery
Patients that will undergo robot assisted laparoscopic surgery and conventional laparoscopic surgery for benign gynecologic disorders will answer 4 questionnaires to assess patient satisfaction, quality of life and cosmesis
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing conventional laparoscopic surgery
* Patients undergoing robot assisted laparoscopic surgery
* Patients undergoing surgery in our hospital by the same surgeon
* Patients willing to participate in the study
Exclusion Criteria
* Requirement of emergency procedure
* Pregnancy
* Visible previous abdominal scars or keloid
* Inability of patient to tolerate Trendelenburg position or pneumoperitoneum
* Patients undergoing surgery by another surgeon or in an another hospital
* Mental impairment that would preclude giving informed consent
18 Years
80 Years
FEMALE
Yes
Sponsors
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Acibadem University
OTHER
Responsible Party
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Esra Ozbasli
Ass. Prof.
Principal Investigators
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Mete Gungor, MD,Prof.
Role: STUDY_DIRECTOR
Acıbadem Mehmet Ali Aydınlar University
Locations
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Acibadem Maslak Hospital
Istanbul, Sariyer, Turkey (Türkiye)
Countries
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References
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Van Loey NE, Van Son MJ. Psychopathology and psychological problems in patients with burn scars: epidemiology and management. Am J Clin Dermatol. 2003;4(4):245-72. doi: 10.2165/00128071-200304040-00004.
Korolija D, Sauerland S, Wood-Dauphinee S, Abbou CC, Eypasch E, Caballero MG, Lumsden MA, Millat B, Monson JR, Nilsson G, Pointner R, Schwenk W, Shamiyeh A, Szold A, Targarona E, Ure B, Neugebauer E; European Association for Endoscopic Surgery. Evaluation of quality of life after laparoscopic surgery: evidence-based guidelines of the European Association for Endoscopic Surgery. Surg Endosc. 2004 Jun;18(6):879-97. doi: 10.1007/s00464-003-9263-x. Epub 2004 Apr 27.
Corrado G, Calagna G, Cutillo G, Insinga S, Mancini E, Baiocco E, Zampa A, Bufalo A, Perino A, Vizza E. The Patient and Observer Scar Assessment Scale to Evaluate the Cosmetic Outcomes of the Robotic Single-Site Hysterectomy in Endometrial Cancer. Int J Gynecol Cancer. 2018 Jan;28(1):194-199. doi: 10.1097/IGC.0000000000001130.
Yeung PP Jr, Bolden CR, Westreich D, Sobolewski C. Patient preferences of cosmesis for abdominal incisions in gynecologic surgery. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):79-84. doi: 10.1016/j.jmig.2012.09.008.
Other Identifiers
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ATADEK-2018/8
Identifier Type: -
Identifier Source: org_study_id
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