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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738085
• Other study ID #: AnkaraU-12-562-16
• Status: Completed
• Start date: January 2011
• Est. completion date: December 2016

Study information

• Verified date: November 2018
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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:

Related Conditions & MeSH terms

• Laparoscopic Surgical Procedure
• Obesity
• Surgery--Complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Evaluate the complication number between groups	Up to one week
Primary	Hospital stay difference	Evaluate the difference of hospitalization day between groups	Up to one week