Postoperative Pain Score of Laparoscopic Gynecological Surgeries

Not Applicable

Completed

• Conditions: Gynecologic Surgery; Postoperative Pain; Surgical Incision
• Interventions: Procedure: laparoscopic incision

• Registration Number: NCT05296928
• Lead Sponsor: Baskent University

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.

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-25
• Study Start: 2022-07-07
• Primary Completion: 2023-04-27
• Study Completion: 2023-05-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

Not provided

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subumbilical incision	laparoscopic incision	Placing a laparoscopic trocar by making a sub-umbilicus incision at the entrance to the abdomen
umbilical incision	laparoscopic incision	Placing the laparoscopic trocar by cutting the umbilicus directly at the entrance to the abdomen

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Başkent University Adana Dr. Turgut Noyan Application and Research Center; 🇹🇷 Adana, Turkey