Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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This prospective randomized controlled trial was planned to be conducted among total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during one year period. The effect of drain insertion during the surgery will be assessed by this clinical trial. Patients will be assigned into two groups as cases and controls. Patients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Patients will be evaluated according to their post operative VAS scores, hematocrit levels, their drainage volume and manifestation of an infection after the surgery.

Detailed Description
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This prospective randomized controlled trial was planned to be conducted from February 2020 to February 2021 and included total laparoscopic hysterectomies performed at Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital during the study period. Surgeries on patients with existing comorbidity, with underlying malignant conditions, patients diagnosed deeply infiltrative endometriosis during surgery and patients who undergo multiple surgeries will be excluded from the study. Clinical and descriptive data will be collected from both paper and electronic records, including the pain of the patient, the need for analgesia at the 6th-12th and 24th hour during the post-operative period. Visual analog scale (VAS) will be used to track the pain progression of the patients. Intraabdominal bleeding will be determined by measuring the hematocrit levels and drainage volume at postoperative day 1. Patients will also be assessed according to manifesting an infection in both the short term and long term. Patients who will a drain inserted will be considered as case group and patients without a drain will be considered as control group. Data will be analyzed using the Statistical Package for Social Sciences (SPSS). A Chi-squared test will be used to evaluate the significance of the associations between variables. Continuous variables will be displayed as means and standard deviations. A P value of ≤0.050 will be considered as significant. This study obtained ethical approval from the Medical Research & Ethics Committee of Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital.

Official Title
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Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy

Conditions
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TOTAL ABDOMINAL HYSTERECTOMY

Intervention / Treatment
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* Procedure: SURGICAL DRAIN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age between 40-70 undergoing surgery for a benign condition having an abdominal surgery for the first time Exclusion Criteria: existing comorbidity with underlying malignant conditions patients diagnosed deeply infiltrative endometriosis during surgery patients who undergone multiple surgeries

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PROSPECTIVE RANDOMISED CONTROLLED TRIAL
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL GROUP<br>patients without a drain | |
| Experimental: CASE GROUP<br>Patients a drain inserted | Procedure: SURGICAL DRAIN<br>* A surgical drain is a tube used to remove blood, abscess and any type of fluid at the site of the place it is inserted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia need at the post-operative period | patient need for analgesia during post operative first day | post operative 6. hour | 
| hematocrit levels | patient hematocrit level at post operative day 1 | post operative first day | 
| drainage volume | drainage volume at postoperative day | post operative first day | 
| post operative infection | manifesting an post operative infection in short term and long term | post operative first day and post operative 1. week | 
| pain post operative 6.-12. and 24. hour | will be measured using VAS score | pain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesia need at the post-operative 6. hour | patient need for analgesia | post-operative 6. hour | 
| analgesia need at the post-operative 12. hour | patient need for analgesia | post-operative 12. hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical drain, visual analog scale, hematocrit