Postoperative Pain Score of Laparoscopic Gynecological Surgeries

Baskent University

Status: Completed

Conditions: Postoperative Pain; Surgical Incision; Gynecologic Surgery

Treatments: Procedure: laparoscopic incision

Study type: Interventional

Funder types: Other

Identifiers

NCT05296928

BaskentU KA21/186

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

umbilical incision

Experimental group

Description:

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

Treatment:

Procedure: laparoscopic incision

subumbilical incision

Active Comparator group

Description:

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

Treatment:

Procedure: laparoscopic incision