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Completed

NCT Number: NCT05296928

Postoperative Pain Score of Laparoscopic Gynecological Surgeries

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.

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Key information

Conditions

Surgical Incision Gynecologic Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Surgical Wound Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Başkent University Adana Dr. Turgut Noyan Application and Research Center

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic incision

Procedure

laparoscopic umbilical trocar entry pathways

Primary outcomes

  1. postoperative pain score

    Time frame: 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 outcomes

  1. postoperative pain score after 24 hour

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

The Effect of the Umbilicus and Sub-umbilicus Incisions Used in Laparoscopic Gynecological Surgeries on the Postoperative Pain Score

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2022
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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