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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-02-01

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.

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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.

Conditions

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TOTAL ABDOMINAL HYSTERECTOMY

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

PROSPECTIVE RANDOMISED CONTROLLED TRIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CONTROL GROUP

patients without a drain

Group Type NO_INTERVENTION

No interventions assigned to this group

CASE GROUP

Patients a drain inserted

Group Type EXPERIMENTAL

SURGICAL DRAIN

Intervention Type PROCEDURE

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

Interventions

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SURGICAL DRAIN

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No