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Postoperative Pain Score of Laparoscopic Gynecological Surgeries

Primary Purpose

Surgical Incision, Gynecologic Surgery, Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laparoscopic incision
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Incision focused on measuring laparoscopic surgery, umbilical incision, postoperative pain score

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria

  1. Patients who underwent laparoscopic hysterectomy for benign reasons
  2. Stage 1 endometrial cancers that only underwent hysterectomy

Exclusion Criteria:

  1. Malign disorders
  2. Uterus larger than 12 weeks of gestation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    umbilical incision

    subumbilical incision

    Arm Description

    Placing the laparoscopic trocar by cutting the umbilicus directly at the entrance to the abdomen

    Placing a laparoscopic trocar by making a sub-umbilicus incision at the entrance to the abdomen

    Outcomes

    Primary Outcome Measures

    postoperative pain score
    The umbilicus, which is the embryonic pathway used in laparoscopic surgery, is expected to cause less postoperative pain.In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.

    Secondary Outcome Measures

    postoperative pain score after 24 hour
    The umbilicus, which is the embryonic pathway used in laparoscopic surgery, is expected to cause less postoperative pain.In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.

    Full Information

    First Posted
    October 28, 2021
    Last Updated
    July 18, 2022
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05296928
    Brief Title
    Postoperative Pain Score of Laparoscopic Gynecological Surgeries
    Official Title
    The Effect of the Umbilicus and Sub-umbilicus Incisions Used in Laparoscopic Gynecological Surgeries on the Postoperative Pain Score
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 21, 2022 (Anticipated)
    Primary Completion Date
    November 21, 2022 (Anticipated)
    Study Completion Date
    December 21, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baskent University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    In this study, it was aimed to compare the embryonic route, the umbilicus, and the sub-umbilicus incision in terms of postoperative pain scoring. For this purpose, in laparoscopic hysterectomies performed for benign reasons, it is planned to measure the pain score at the 8th hour and 1st day postoperatively in the umbilicus and subumbilical incision. Visual analog scoring system will be used for pain scoring.
    Detailed Description
    In this prospective randomized study, Baskent University Adana Dr. Turgut Noyan Application and Research Center for benign reasons (myomas that cause abnormal uterine bleeding, resistant to medical and hysterescopic surgery, treatment-resistant adenomyosis in which the uterus reaches 12 weeks of gestation, recurrent endometrial hyperplasia, endometriosis, stage 1 endometrial cancers that only underwent hysterectomy) in laparoscopic hysterectomies; at the entrance to the abdomen, it is planned to apply the umbilicus, which is the anatomical route, to some of the patients, and to the other part of the sub-umbilicus incision. It will be compared in terms of pain score on the 8th hour and 1st day after surgery. The minimum quorum for each group was determined by calculating 41 and taking a total of 82 patients. The simple randomization technique will be applied in the distribution to the study sets. Based on the studies, it is thought that the anatomical path may be less painful.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Incision, Gynecologic Surgery, Postoperative Pain
    Keywords
    laparoscopic surgery, umbilical incision, postoperative pain score

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    82 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    umbilical incision
    Arm Type
    Experimental
    Arm Description
    Placing the laparoscopic trocar by cutting the umbilicus directly at the entrance to the abdomen
    Arm Title
    subumbilical incision
    Arm Type
    Active Comparator
    Arm Description
    Placing a laparoscopic trocar by making a sub-umbilicus incision at the entrance to the abdomen
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic incision
    Intervention Description
    laparoscopic umbilical trocar entry pathways
    Primary Outcome Measure Information:
    Title
    postoperative pain score
    Description
    The umbilicus, which is the embryonic pathway used in laparoscopic surgery, is expected to cause less postoperative pain.In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.
    Time Frame
    8 hour
    Secondary Outcome Measure Information:
    Title
    postoperative pain score after 24 hour
    Description
    The umbilicus, which is the embryonic pathway used in laparoscopic surgery, is expected to cause less postoperative pain.In the Visual Analog Score to be used as the pain measurement criterion, '0' indicates no pain, while '10' defines the most severe pain.
    Time Frame
    24 hour

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria Patients who underwent laparoscopic hysterectomy for benign reasons Stage 1 endometrial cancers that only underwent hysterectomy Exclusion Criteria: Malign disorders Uterus larger than 12 weeks of gestation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    didem alkaş yağınç
    Phone
    05398394853
    Email
    didem.alkas@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    hüsnü çelik
    Email
    drhusnucelik@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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