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Role of Oxidative Stress in Ovarian Tissue After CO2-pneumoperitoneum Application-induced I/R

Primary Purpose

Oophorectomy, Oxidative Stress, Ischemia Reperfusion Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
laparoscopic salpingo-oophorectomy
Laparoscopic bilateral salpingo-oophorectomy
Sponsored by
Ismet Hortu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oophorectomy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Transgender Men who wants to remove their uterus and both ovaries.

Exclusion Criteria:

  • Known endometriosis
  • Hysterectomized patient
  • Unacceptance to involve to the trial
  • Suspicion of malignancy

Sites / Locations

  • Ege University School of Medicine, Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Investigation

Arm Description

Unilateral oophorectomy was performed immediately after abdominal entry, and the remaining contralateral ovary was excised at the end of the hysterectomy in order to compare the effect of these surgical procedures on ovarian tissue.

Outcomes

Primary Outcome Measures

Impact of CO2 pneumoperitoneum on ovaries by comparing histopathology
Histopathological investigation of ovaries after CO2 pneumoperitoneum -induced I/R

Secondary Outcome Measures

Full Information

First Posted
July 26, 2020
Last Updated
May 23, 2021
Sponsor
Ismet Hortu
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1. Study Identification

Unique Protocol Identification Number
NCT04493983
Brief Title
Role of Oxidative Stress in Ovarian Tissue After CO2-pneumoperitoneum Application-induced I/R
Official Title
Evaluation of Oxidative Stress-related Biomarkers With a Histopathological and Biochemical Approach in Ovarian Tissue From a Human Carbondioxide Pneumoperitoneum-applied Ischemia/Reperfusion Model
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ismet Hortu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Because of cellular changes in response to ischemia and a following period of reperfusion, damages to organs and different tissues occur. There are several ongoing studies to enlighten the pathophysiological processes underlying these damages inflicted by ischemia/reperfusion. Gases (CO2) with low water content are used in pneumoperitoneum, which is a procedure to inflate the abdominal cavity with an appropriate gas for laparoscopic operations. In the current literature, it was shown that due to a restricted blood flow during the gas insufflation, ischemia develops and with the reperfusion of the organ in deflation period, oxidative stress and inflammation increases, leading to ischemia/reperfusion-related organ and tissue damages. In the proposed study, biomarkers for ischemia/reperfusion-inflicted damage will be evaluated in a biochemical and histopathological perspective in biopsy samples of ovaries from a young patient group in which hysterectomy and bilateral salpingo-oophorectomy will be performed, laparoscopically.
Detailed Description
In the laparoscopic salpingo-oophorectomy, after the induction of anesthesia, an umbilical skin incision was performed. Pneumoperitoneum was established using dry, nonheated CO2 insufflation through a Veress needle. A 10-mm trocar was inserted into the abdominal cavity through the umbilical incision for the laparoscope. Subsequently, three 5-mm ancillary trocars, 2 on the lower abdominal quadrants and 1 on the left upper quadrant, were introduced to the abdominal space under direct optic visualization. IAP was set at 14 mm Hg and maintained with a gas insufflator (Endoflator; Karl Storz Endoscopy, Tuttlingen, Germany)Immediately after the port placement, unilateral oophorectomy was performed, and ovarian biopsies were obtained. The operation continued with ligation and transection of the contralateral utero-ovarian ligament and the bilateral round ligaments. The contralateral infundibulopelvic ligament, which contains the main vascular supply for the contralateral ovary, remained intact. Subsequently, anterior and posterior leaflets of the broad ligament were identified and dissected, and the bladder was placed away from the lower uterine segment. The uterus removed from vaginal way after necessary steps. After desufflation, the cuff closure procedure was performed vaginally. At the end of the closure, pneumoperitoneum was reestablished, the remaining contralateral ovary was removed immediately, and biopsies were obtained for histologic analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oophorectomy, Oxidative Stress, Ischemia Reperfusion Injury

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigation
Arm Type
Other
Arm Description
Unilateral oophorectomy was performed immediately after abdominal entry, and the remaining contralateral ovary was excised at the end of the hysterectomy in order to compare the effect of these surgical procedures on ovarian tissue.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic salpingo-oophorectomy
Intervention Description
Laparoscopic bilateral salpingo-oophorectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic bilateral salpingo-oophorectomy
Intervention Description
Unilateral oophorectomy was performed immediately after abdominal entry, and the remaining contralateral ovary was excised at the end of the hysterectomy in order to compare the effect of these surgical procedures on ovarian tissue.
Primary Outcome Measure Information:
Title
Impact of CO2 pneumoperitoneum on ovaries by comparing histopathology
Description
Histopathological investigation of ovaries after CO2 pneumoperitoneum -induced I/R
Time Frame
1-day (at the time of the surgery)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Transgender Men who wants to remove their uterus and both ovaries. Exclusion Criteria: Known endometriosis Hysterectomized patient Unacceptance to involve to the trial Suspicion of malignancy
Facility Information:
Facility Name
Ege University School of Medicine, Department of Obstetrics and Gynecology
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19081089
Citation
Guven S, Muci E, Unsal MA, Yulug E, Alver A, Kadioglu Duman M, Mentese A. The effects of carbon dioxide pneumoperitoneum on ovarian blood flow, oxidative stress markers, and morphology during laparoscopy: a rabbit model. Fertil Steril. 2010 Mar 1;93(4):1327-32. doi: 10.1016/j.fertnstert.2008.10.053. Epub 2008 Dec 9.
Results Reference
result
PubMed Identifier
11283527
Citation
Schafer M, Krahenbuhl L. Effect of laparoscopy on intra-abdominal blood flow. Surgery. 2001 Apr;129(4):385-9. doi: 10.1067/msy.2001.110224. No abstract available.
Results Reference
result
PubMed Identifier
15229201
Citation
Cevrioglu AS, Yilmaz S, Koken T, Tokyol C, Yilmazer M, Fenkci IV. Comparison of the effects of low intra-abdominal pressure and ischaemic preconditioning on the generation of oxidative stress markers and inflammatory cytokines during laparoscopy in rats. Hum Reprod. 2004 Sep;19(9):2144-51. doi: 10.1093/humrep/deh380. Epub 2004 Jun 30.
Results Reference
result
PubMed Identifier
25618113
Citation
Biler A, Yucebilgin S, Sendag F, Akman L, Akdemir A, Ates U, Uyanikgil Y, Yilmaz-Dilsiz O, Sezer E. The effects of different intraabdominal pressure protocols in laparoscopic procedures on oxidative stress markers and morphology in rat ovaries. Adv Clin Exp Med. 2014 Nov-Dec;23(6):885-92. doi: 10.17219/acem/37331.
Results Reference
result
PubMed Identifier
29107119
Citation
Akdemir A, Taylan E, Sahin C, Ozgurel B, Karlitepe A, Zekioglu O, Ercan G. The Impact of Carbon Dioxide Pneumoperitoneum on Ovarian Ischemia-Reperfusion Injury during Laparoscopic Surgery: A Preliminary Study. J Minim Invasive Gynecol. 2018 May-Jun;25(4):638-643. doi: 10.1016/j.jmig.2017.10.018. Epub 2017 Nov 28.
Results Reference
result

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Role of Oxidative Stress in Ovarian Tissue After CO2-pneumoperitoneum Application-induced I/R

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