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

NCT ID: NCT04064216

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-16

Study Completion Date

2020-03-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Disease Cosmesis Patient Satisfaction Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robot assisted laparoscopic surgery

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

Laparoscopic surgery

Intervention Type 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

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

Laparoscopic surgery

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Esra Ozbasli

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mete Gungor, MD,Prof.

Role: STUDY_DIRECTOR

Acıbadem Mehmet Ali Aydınlar University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Acibadem Maslak Hospital

Istanbul, Sariyer, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12680803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15108103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29040189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23312246 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ATADEK-2018/8

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.