Postoperative Pain Score of Laparoscopic Gynecological Surgeries

Sponsor
Baskent University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05296928
Collaborator
(none)
82
2
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic incision
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of the Umbilicus and Sub-umbilicus Incisions Used in Laparoscopic Gynecological Surgeries on the Postoperative Pain Score
Anticipated Study Start Date :
Jul 21, 2022
Anticipated Primary Completion Date :
Nov 21, 2022
Anticipated Study Completion Date :
Dec 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: umbilical incision

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

Procedure: laparoscopic incision
laparoscopic umbilical trocar entry pathways

Active Comparator: subumbilical incision

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

Procedure: laparoscopic incision
laparoscopic umbilical trocar entry pathways

Outcome Measures

Primary Outcome Measures

  1. postoperative pain score [8 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.

Secondary Outcome Measures

  1. postoperative pain score after 24 hour [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Didem Alkaş Yağınç, Principal Investigator, Baskent University
ClinicalTrials.gov Identifier:
NCT05296928
Other Study ID Numbers:
  • BaskentU KA21/186
First Posted:
Mar 25, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Didem Alkaş Yağınç, Principal Investigator, Baskent University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022