Clinical trial NCT04064216: Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Laparoscopic Surgery
Official title: Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Robot Assisted Versus Conventional Laparoscopic Surgery for Bening Gynecologic Disorders: a Prospective Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Disease
Cosmesis
Patient Satisfaction
Quality of Life
Keywords: Cosmesis
Laparoscopic surgery
Patient satisfaction
Scar assessment
Quality of life
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 patients undergoing robot assisted laparoscopic surgery for bening gynecologic disorders and 30 patients undergoing conventional laparoscopic surgery for bening gynecologic disorders will be included in our study.

Brief summary: To compare robot assisted versus conventional laparoscopic surgery performed for bening gynecologic disorders regarding cosmesis, patient satisfaction and quality of life

Detailed description: 30 patients undergoing robot assisted laparoscopic surgery for bening gynecologic disorders and 30 patients undergoing conventional laparoscopic surgery for bening gynecologic disorders will be included in the study. All surgeries will be performed in the same hospital by the same surgeon. 6 months after the surgery the patients will be called and will be informed about the trial. After confirming that the questionnaires can be sent to them by e-mail, 4 questionnaires will be sent to the patients via e-mail. To evaluate cosmesis, patient satisfaction and quality of life VAS (visual analogue scale), SF-12 (short form-12) health survey, BIQ (body image questionnaire) and POSAS (the patient and observer scar assessment scale) will be sent to the patients 6 months after the surgery. Patients who have not completed the questionnaires will be called for reminders after 1 week. Patients will be expected to complete the questionnaire completely and accurately.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of being gynecologic disorders
* 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:

* Malignancy
* 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

Primary outcomes:
measure: Patient-perceived cosmesis
timeFrame: 6 months after the surgery
measure: Patient and observer scar assessment
timeFrame: 6 months after the surgery
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 months after the surgery
measure: Quality of life after robot assisted versus conventional laparoscopic surgery
timeFrame: 6 months after the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
state: Sariyer
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Mete Gungor, MD,Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.