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

NCT04285502 | Unknown

• 1 other identifier: ZEYNEPKAMILHOSPITAL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

TOTAL ABDOMINAL HYSTERECTOMY

Keywords

surgical drain; visual analog scale; hematocrit

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• analgesia need at the post-operative 6. hour

  post-operative 6. hour

• analgesia need at the post-operative 12. hour

  post-operative 12. hour

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

patients without a drain

CASE GROUP

EXPERIMENTAL

Patients a drain inserted

Procedure: SURGICAL DRAIN

Interventions

SURGICAL DRAIN 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

CASE GROUP

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• age between 40-70
• undergoing surgery for a benign condition
• having an abdominal surgery for the first time

You may not qualify if:

• existing comorbidity
• with underlying malignant conditions
• patients diagnosed deeply infiltrative endometriosis during surgery
• patients who undergone multiple surgeries

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (2)

Zeynep Kamil Maternity and Children Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Zeynep Kamil

Istanbul, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 32044017 RESULT

Related 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATED PROFESSOR

Model Details: PROSPECTIVE RANDOMISED CONTROLLED TRIAL

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 26, 2020
• Study Start: March 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)