Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Total Laparoscopic Hysterectomy
Comparison of Postoperative Drain Insertion Versus No Drain Insertion In Patients Undergone Total Laparoscopic Hysterectomy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Istanbul, Tyrkia
- Rekruttering
- Zeynep Kamil
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Ta kontakt med:
- enis ozkaya, md
- Telefonnummer: 0090 5054742459
- E-post: enokaya1979@gmail.com
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Istanbul, Tyrkia
- Rekruttering
- Zeynep Kamil Maternity and Children Training and Research Hospital
-
Ta kontakt med:
- enis ozkaya, associated professor
- Telefonnummer: 0090 216 334 94 00
- E-post: istzeynepkeah.hhak@saglik.gov.tr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: CONTROL GROUP
patients without a drain
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|
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Eksperimentell: CASE GROUP
Patients a drain inserted
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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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
analgesia need at the post-operative period
Tidsramme: post operative 6. hour
|
patient need for analgesia during post operative first day
|
post operative 6. hour
|
|
hematocrit levels
Tidsramme: post operative first day
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patient hematocrit level at post operative day 1
|
post operative first day
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drainage volume
Tidsramme: post operative first day
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drainage volume at postoperative day
|
post operative first day
|
|
post operative infection
Tidsramme: post operative first day and post operative 1. week
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manifesting an post operative infection in short term and long term
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post operative first day and post operative 1. week
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|
pain post operative 6.-12. and 24. hour
Tidsramme: pain
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will be measured using VAS score
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pain
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
analgesia need at the post-operative 6. hour
Tidsramme: post-operative 6. hour
|
patient need for analgesia
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post-operative 6. hour
|
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analgesia need at the post-operative 12. hour
Tidsramme: post-operative 12. hour
|
patient need for analgesia
|
post-operative 12. hour
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ZEYNEPKAMILHOSPITAL
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