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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Surgery--Complications; Laparoscopic Surgical Procedure

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 Type: Observational
• Enrollment (Actual): 380

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All women who underwent TLH for benign conditions

Description

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:

• No

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Principal Investigator: Batuhan Turgay, Ankara University; Principal Investigator: Bulent Berker, Professor, Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 9, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Complication; Total laparoscopic hysterectomy; Previous surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: AnkaraU-12-562-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No