Clinical trial NCT04285502: Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy
Official title: Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: TOTAL ABDOMINAL HYSTERECTOMY
Keywords: surgical drain
visual analog scale
hematocrit
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: PROSPECTIVE RANDOMISED CONTROLLED TRIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: analgesia need at the post-operative period
timeFrame: post operative 6. hour
measure: hematocrit levels
timeFrame: post operative first day
measure: drainage volume
timeFrame: post operative first day
measure: post operative infection
timeFrame: post operative first day and post operative 1. week
measure: pain post operative 6.-12. and 24. hour
timeFrame: pain
Secondary outcomes:
measure: analgesia need at the post-operative 6. hour
timeFrame: post-operative 6. hour
measure: analgesia need at the post-operative 12. hour
timeFrame: post-operative 12. hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Children Training and Research Hospital
city: Istanbul
country: Turkey
facility: Zeynep Kamil
Study officials:
References:
citation: Weston M, Soyer P, Barral M, Dohan A, Pierre S, Rabei R, Garcia-Reyes K, Kohi MP. Role of Interventional Procedures in Obstetrics and Gynecology. Radiol Clin North Am. 2020 Mar;58(2):445-462. doi: 10.1016/j.rcl.2019.11.006.