An interventional study of SURGICAL DRAIN in TOTAL ABDOMINAL HYSTERECTOMY, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Status unknown at 2 sites in Turkey. Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Treatment
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.
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.
Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients without a drain
Patients a drain inserted
Procedure: 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
analgesia need at the post-operative period
patient need for analgesia during post operative first day
Time frame: post operative 6. hour
hematocrit levels
patient hematocrit level at post operative day 1
Time frame: post operative first day
drainage volume
drainage volume at postoperative day
Time frame: post operative first day
post operative infection
manifesting an post operative infection in short term and long term
Time frame: post operative first day and post operative 1. week
pain post operative 6.-12. and 24. hour
will be measured using VAS score
Time frame: pain
analgesia need at the post-operative 6. hour
patient need for analgesia
Time frame: post-operative 6. hour
analgesia need at the post-operative 12. hour
patient need for analgesia
Time frame: post-operative 12. hour
Plan to share: No
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Zeynep Kamil Maternity and Pediatric Research and Training Hospital