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Postoperative Pain Score of Laparoscopic Gynecological Surgeries

NCT ID: NCT05296928

Last Updated: 2024-12-27

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2023-05-27

Brief Summary

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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

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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.

Conditions

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Surgical Incision Gynecologic Surgery Postoperative Pain

Keywords

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laparoscopic surgery umbilical incision postoperative pain score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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umbilical incision

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

Group Type EXPERIMENTAL

laparoscopic incision

Intervention Type PROCEDURE

laparoscopic umbilical trocar entry pathways

subumbilical incision

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

Group Type ACTIVE_COMPARATOR

laparoscopic incision

Intervention Type PROCEDURE

laparoscopic umbilical trocar entry pathways

Interventions

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laparoscopic incision

laparoscopic umbilical trocar entry pathways

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Didem Alkaş Yağınç

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Başkent University Adana Dr. Turgut Noyan Application and Research Center

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BaskentU KA21/186

Identifier Type: -

Identifier Source: org_study_id