Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Single-port and Three-port Laparoscopy

March 11, 2015 updated by: Yong Seok Lee, The Catholic University of Korea

Postoperative Pain After Total Laparoscopic Hysterectomy: a Comparison of Transumbilical Single-port Access and Conventional Three-port Laparoscopic Surgery

The objective of this study is to compare postoperative pain between single-port access total laparoscopic hysterectomy (SPA-TLH) using a transumbilical single-port system and conventional multi (three)-port access total laparoscopic hysterectomy (MPA-TLH). A prospective study was conducted on women who underwent SPA-TLH and MPA-TLH for benign gynecologic diseases from March 2014 through January 2015. The study enrolled 60 patients and postoperative pain and operative outcomes were examined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The randomization code was inserted into numbered and sealed envelopes. A single envelope was opened when the patient was arrived in operating room. All patients gave their informed consent for the study and underwent hysterectomy for benign diseases. After surgery, in all patients, three sticking plasters were applied by the same manner with three port surgery group therefore not only patients but also anesthesiology staff who measure the pain score could not know the type of surgery until data collection was finished. Pain was assessed according to the visual analog scale (VAS) (0 = no pain; 10 = worst pain imaginable). Patients were asked to evaluate the maximal degree of pain. Pain scores were recorded at least at 30 minutes, 1, 12, 24 and 48 hours after surgery. Postoperative pain was measured by two independent anesthesiology staff members for cross-checking. In order to compare the intensity of postoperative pain accurately, all the participants had anesthesia in the same way and postoperative pain was managed by fentanyl-based intravenous patient-controlled analgesia pump (IV-PCA, Baxter healthcare Corporation, U.S.A: bolus dose 0.12mg/kg of fentanyl, lockout interval of 5 min, basal infusion 0.02ml/kg) with the same regimen on both groups. A patient was instructed to press the IV-PCA bolus button when the VAS was 3 or higher. A patient under IV-PCA whose VAS was over 5 received 50mg of Tridol injection intravenously. IV-PCA was removed 48 hours after surgery unless a patient specially asked it. Then, using log data downloaded by a program, we analyzed the number of IV-PCA bolus requests by time interval, total amount of fentanyl consumption, and the number of additional Tridol administration and injection time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Incluson Criteria

  1. Subject has benign uterine disease
  2. Subject needs total hysterectomy.
  3. Subject has appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification system 1-3).

Exclusion Criteria:

  1. suspicion of malignancy
  2. the need for simultaneous interventions such as prolapse repair
  3. uterine size greater than 18 weeks of gestation
  4. ongoing peritoneal dialysis
  5. diseases associated with abdominal pain such as pancreatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: single-port laparoscopic hysterectomy
total laparoscopic hysterectomy via transumbilical single port
Device: single-port laparoscopic hysterectomy(single port trochar)
perform laparoscopic hysterectomy via single-port access
Active Comparator: multi-port laparoscopic hysterectomy
total laparoscopic hysterectomy via multi-port (3 port)
Device: multi-port laparoscopic hysterectomy(multi port trochar)
perform laparoscopic hysterectomy via multi-port access

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
postoperative pain (Pain scores) intensity measure
Time Frame: 2 days
self reported pain intensity measure for 2 days after surgery
2 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse events
Time Frame: up to 24 weeks
perioperative adverse event including bowel, bladder injury and severe hemorrahge
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Catholic University of Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ji-Hyun Chung, MD, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DC14EISI0026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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