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

TOTAL ABDOMINAL HYSTERECTOMY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04285502
• Other study ID #: ZEYNEPKAMILHOSPITAL
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2020
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• TOTAL ABDOMINAL HYSTERECTOMY

Intervention

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

Locations

Country	Name	City	State
Turkey	Zeynep Kamil	Istanbul
Turkey	Zeynep Kamil Maternity and Children Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. Review. — View Citation

Outcome

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

External Links

•   Post-Caesarean Drain Placement - Minor Procedure Leading to Major Complication
•   The effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery: a double-blinded randomized controlled trial