NCT03738085

Brief Summary

Previous surgery and obesity has disputed as an unfavorable factor during Total Laparoscopic Hysterectomy. The aim of the investigator's study was to assess the effects of previous abdominal surgery and obesity on intra-operative and post-operative outcomes of TLH.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

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, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

3.9 years

First QC Date

November 8, 2018

Last Update Submit

November 9, 2018

Conditions

Laparoscopic Surgical ProcedureObesitySurgery--Complications

Keywords

ComplicationPrevious surgeryTotal laparoscopic hysterectomyObesity

Outcome Measures

Primary Outcomes (2)

  • Complication rate

    Evaluate the complication number between groups

    Up to one week

  • Hospital stay difference

    Evaluate the difference of hospitalization day between groups

    Up to one week

Study Arms (4)

Previous abdominal surgery group

Previous abdominal surgery group underwent total laparoscopic hysterectomy

No previous abdominal surgery group

No Previous abdominal surgery group underwent total laparoscopic hysterectomy

Obese patients underwent TAH

BMI≥30 kg/m2

Obese patients underwent TLH

BMI≥30 kg/m2

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsparticipant eligibility is based on self-representation of gender identity and physical status
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All women who underwent TLH for benign conditions

You may qualify if:

  • all women who underwent TLH for benign conditions during study period
  • all obese ≥30 kg/m2 women who underwent TAH for benign conditions during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Batuhan Turgay

    Ankara University

    PRINCIPAL INVESTIGATOR

  • Bulent Berker, Professor

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 13, 2018

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2016

Last Updated

November 14, 2018

Record last verified: 2018-11