TOTAL ABDOMINAL HYSTERECTOMYNCT04285502
Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy
A study testing SURGICAL DRAIN in people with TOTAL ABDOMINAL HYSTERECTOMY, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- TOTAL ABDOMINAL HYSTERECTOMY
- What is being tested?
- SURGICAL DRAIN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- age between 40-70
- undergoing surgery for a benign condition
- having an abdominal surgery for the first time
Who cannot join
- existing comorbidity
- with underlying malignant conditions
- patients diagnosed deeply infiltrative endometriosis during surgery
- patients who undergone multiple surgeries
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Zeynep Kamil Maternity and Children Training and Research Hospital
Istanbul
enis ozkaya, associated professor, 216 334 94 00 ext. 0090, istzeynepkeah.hhak@saglik.gov.tr
- Recruiting
Zeynep Kamil
Istanbul
enis ozkaya, md, 5054742459 ext. 0090, enokaya1979@gmail.com
About this study
Official title: Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy
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.
Read the 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.
- Conditions
- TOTAL ABDOMINAL HYSTERECTOMY
- Being tested
- SURGICAL DRAIN
- Keywords
- surgical drain, visual analog scale, hematocrit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGICAL DRAINProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP | No intervention | patients without a drain |
| CASE GROUP | Experimental | Patients a drain inserted Receives: Procedure: SURGICAL DRAIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia need at the post-operative period
patient need for analgesia during post operative first day
Measured: post operative 6. hour
hematocrit levels
patient hematocrit level at post operative day 1
Measured: post operative first day
drainage volume
drainage volume at postoperative day
Measured: post operative first day
post operative infection
manifesting an post operative infection in short term and long term
Measured: post operative first day and post operative 1. week
pain post operative 6.-12. and 24. hour
will be measured using VAS score
Measured: pain
Secondary outcomes (2)
analgesia need at the post-operative 6. hour
patient need for analgesia
Measured: post-operative 6. hour
analgesia need at the post-operative 12. hour
patient need for analgesia
Measured: post-operative 12. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TOTAL ABDOMINAL HYSTERECTOMYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PROSPECTIVE RANDOMISED CONTROLLED TRIAL
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, enis ozkaya, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285502
- Sponsor's protocol ID
- ZEYNEPKAMILHOSPITAL
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32044017
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04285502
- Acronym / sponsor ID
- ZEYNEPKAMILHOSPITAL
- Conditions
- TOTAL ABDOMINAL HYSTERECTOMY
- Keywords
- surgical drain, visual analog scale, hematocrit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PROSPECTIVE RANDOMISED CONTROLLED TRIAL
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP | No intervention | –patients without a drain |
| CASE GROUP | Experimental | Procedure: SURGICAL DRAINPatients a drain inserted |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- age between 40-70
- undergoing surgery for a benign condition
- having an abdominal surgery for the first time
Key exclusion criteria (4 listed)
- existing comorbidity
- with underlying malignant conditions
- patients diagnosed deeply infiltrative endometriosis during surgery
- patients who undergone multiple surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SURGICAL DRAINA surgical drain is a tube used to remove blood, abscess and any type of fluid at the site of the place it is inserted | Procedure or surgery | CASE GROUP |
Primary outcome
analgesia need at the post-operative period
Time frame: post operative 6. hour
patient need for analgesia during post operative first day
hematocrit levels
Time frame: post operative first day
patient hematocrit level at post operative day 1
drainage volume
Time frame: post operative first day
drainage volume at postoperative day
post operative infection
Time frame: post operative first day and post operative 1. week
manifesting an post operative infection in short term and long term
pain post operative 6.-12. and 24. hour
Time frame: pain
will be measured using VAS score
2 secondary outcomes
analgesia need at the post-operative 6. hour
Time frame: post-operative 6. hour
analgesia need at the post-operative 12. hour
Time frame: post-operative 12. hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Results publication: PubMed 32044017Weston 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.
- Post-Caesarean Drain Placement - Minor Procedure Leading to Major ComplicationLink provided by the sponsor.
- The effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery: a double-blinded randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Kamil Maternity and Children Training and Research Hospital
Istanbul, Turkey (Türkiye)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURGICAL DRAIN in people with TOTAL ABDOMINAL HYSTERECTOMY, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesia need at the post-operative period (time frame: post operative 6. hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04285502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020; AzTrials last refreshed its copy on 1 Nov 2026.