Previous Abdominal Surgery and Obesity Does Not Affect Unfavorably the Outcome of Total Laparoscopic Hysterectomy

Sponsor

Ankara University (Other)

Overall Status

Completed

CT.gov ID

NCT03738085

Collaborator

(none)

380

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Surgical Procedure Obesity Surgery--Complications

Detailed Description

Abstract:

Objective: To assess the effects of previous abdominal surgery and obesity on the intra-operative and post-operative outcomes of total laparoscopic hysterectomy (TLH).

Method: In this retrospective cohort study, women who underwent TLH for benign conditions between January 2011 and December 2016 in tertiary academic center were included. Patients were grouped according to previous abdominal surgery. The study group consisted of patients who had at least one previous abdominal surgery and the control group consisted of patients with no previous abdominal surgery. In a further analysis, a subgroup of obese patients with BMI (body mass index) ≥30 kg/m2 was evaluated. For this analysis, the obese patients who underwent TLH were picked up and the results were compared to the results of obese patients who underwent total abdominal hysterectomy (TAH) during the same time period. The main outcome parameters were duration of hospital stay and major complication rate.

Study Design

Study Type:

Observational

Actual Enrollment :

380 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Previous Abdominal Surgery and Obesity Does Not Affect Unfavorably the Outcome of Total Laparoscopic Hysterectomy

Actual Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Complication rate [Up to one week]
Evaluate the complication number between groups
Hospital stay difference [Up to one week]
Evaluate the difference of hospitalization day between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ankara University

Investigators

Principal Investigator: Batuhan Turgay, Ankara University
Principal Investigator: Bulent Berker, Professor, Ankara University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Batuhan Turgay, Principal Investigator, Ankara University

ClinicalTrials.gov Identifier:

NCT03738085

Other Study ID Numbers:

AnkaraU-12-562-16

First Posted:

Nov 13, 2018

Last Update Posted:

Nov 14, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Batuhan Turgay, Principal Investigator, Ankara University

Complication

Previous surgery

Total laparoscopic hysterectomy

Obesity

Additional relevant MeSH terms:

Obesity

Study Results

No Results Posted as of Nov 14, 2018