Comparison of Cosmesis, Patient Satisfaction and Quality of Life in Patients Undergoing Laparoscopic Surgery

NCT04064216 | Completed

• 1 other identifier: ATADEK-2018/8
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gynecologic Disease; Cosmesis; Patient Satisfaction; Quality of Life

Keywords

Cosmesis; Laparoscopic surgery; Patient satisfaction; Scar assessment; Quality of life

Outcome Measures

Primary Outcomes (2)

• Patient-perceived cosmesis

  The primary outcome is to evaluate patient's satisfaction about their laparoscopic incision scars 6 months after the surgery. 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, questionnaires will be sent to the patients. BIQ (body image questionnaire) multiple choice questionnaire to evaluate their scar 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 questionnaires completely and accurately.

  6 months after the surgery

• Patient and observer scar assessment

  The primary outcome is to evaluate patient's satisfaction about their laparoscopic incision scars 6 months after the surgery. 6 months after the surgery the patients will be called and will be informed about our trial. After confirming that the questionnaires can be sent to them by e-mail, questionnaires will be sent to the patients. POSAS (the patient and observer scar assessment scale) multiple choice questionnaires to evaluate their scar 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 questionnaires completely and accurately.

  6 months after the surgery

Secondary Outcomes (2)

• Patient satisfaction

  6 months after the surgery

• Quality of life after robot assisted versus conventional laparoscopic surgery

  6 months after the surgery

Study Arms (2)

Robot assisted laparoscopic surgery

This group will be consisted of patients that will undergo robot assisted laparoscopic surgery for benign gynecologic disorders

Procedure: Laparoscopic surgery

Conventional laparoscopic surgery

This group will be consisted of patients that will undergo conventional laparoscopic surgery for benign gynecologic disorders

Procedure: Laparoscopic surgery

Interventions

Laparoscopic surgery PROCEDURE

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; Robot assisted laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 12680803 BACKGROUND

• 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.

  PMID: 15108103 BACKGROUND

• 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.

  PMID: 29040189 BACKGROUND

• 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.

  PMID: 23312246 BACKGROUND

MeSH Terms

Conditions

Genital Diseases, Female; Patient Satisfaction

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Mete Gungor, MD,Prof.

  Acıbadem Mehmet Ali Aydınlar University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 21, 2019
• Study Start: July 16, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 16, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)