NCT05296928

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 7, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2023

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

October 28, 2021

Last Update Submit

December 24, 2024

Conditions

Surgical IncisionGynecologic SurgeryPostoperative Pain

Keywords

laparoscopic surgeryumbilical incisionpostoperative pain score

Outcome Measures

Primary Outcomes (1)

  • postoperative pain score

    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.

    8 hour

Secondary Outcomes (1)

  • postoperative pain score after 24 hour

    24 hour

Study Arms (2)

umbilical incision

EXPERIMENTAL

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

Procedure: laparoscopic incision

subumbilical incision

ACTIVE COMPARATOR

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

Procedure: laparoscopic incision

Interventions

laparoscopic incisionPROCEDURE

laparoscopic umbilical trocar entry pathways

subumbilical incisionumbilical incision

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent laparoscopic hysterectomy for benign reasons
  • Stage 1 endometrial cancers that only underwent hysterectomy

You may not qualify if:

  • Malign disorders
  • Uterus larger than 12 weeks of gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent University Adana Dr. Turgut Noyan Application and Research Center

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical WoundPain, Postoperative

Condition Hierarchy (Ancestors)

Wounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2021

First Posted

March 25, 2022

Study Start

July 7, 2022

Primary Completion

April 27, 2023

Study Completion

May 27, 2023

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)