NCT05003297

Brief Summary

Due to short hospital stay, rapid return to work, less pain, and good cosmetic results, laparoscopic hysterectomy ( LH) has substantially increased the era of hysterectomy procedures especially for the last two decades. The main reason for this is probably that LH leads to fewer inflammatory responses when compared to open abdominal hysterectomy. Although the inflammatory response is supposed to be lower with total laparoscopic hysteroscopy (TLH), unpredictable inflammatory response as a result of the operation has been still unenlightened and it can be associated with hospital stay.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
Last Updated

August 25, 2021

Status Verified

July 1, 2021

Enrollment Period

4.9 years

First QC Date

August 1, 2021

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Postoperative NLR values compared in patients who were hospitalized for more than 3 days and equal to or less than 3 days.

    NLR was calculated by dividing the absolute number of neutrophil to the absolute number of lymphocytes.

    4 years

  • Postoperative PLR values compared in patients who were hospitalized for more than 3 days and equal to or less than 3 days.

    PLR were calculated by dividing the absolute number of platelets to the absolute number of lymphocytes.

    4 years

Study Arms (2)

patients whom were hospitalized for 3 days or less

Other: hemogram inflammatory parameters

patients hospitalized for more than 3 days

Other: hemogram inflammatory parameters

Interventions

Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR)

patients hospitalized for more than 3 dayspatients whom were hospitalized for 3 days or less

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients whom have undergone TLH without any postoperative surgical complications

You may qualify if:

  • Patients whom have undergone TLH

You may not qualify if:

  • Ureter injury
  • Bladder injury,
  • Bowel injury,
  • Superficial inferior mesenteric artery injury
  • Vaginal cuff hematoma
  • Vaginal cuff dehiscence
  • Endometriosis
  • Endometrial cancer
  • Cervical cancer
  • Chronic lymphocytic leukemia
  • Behçet disease
  • Electrolyte imbalance
  • Thyroid disease
  • Using anti-inflammatory medications
  • Having severe intraabdominal adhesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 1, 2021

First Posted

August 12, 2021

Study Start

January 1, 2014

Primary Completion

November 30, 2018

Study Completion

December 30, 2018

Last Updated

August 25, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
The data is available now