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

NCT ID: NCT04493983

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-09-01

Brief Summary

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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

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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.

Conditions

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Oophorectomy Oxidative Stress Ischemia Reperfusion Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Investigation

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.

Group Type OTHER

laparoscopic salpingo-oophorectomy

Intervention Type PROCEDURE

Laparoscopic bilateral salpingo-oophorectomy

Laparoscopic bilateral salpingo-oophorectomy

Intervention Type PROCEDURE

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.

Interventions

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laparoscopic salpingo-oophorectomy

Laparoscopic bilateral salpingo-oophorectomy

Intervention Type PROCEDURE

Laparoscopic bilateral salpingo-oophorectomy

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ismet Hortu

OTHER

Sponsor Role lead

Responsible Party

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Ismet Hortu

Clinical researcher, Ismet Hortu, MD., PhD. Department of Obstetrics and Gynecology, Ege University School of Medicine, Izmir, Turkey

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ege University School of Medicine, Department of Obstetrics and Gynecology

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 29107119 (View on PubMed)

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.

Reference Type RESULT
PMID: 19081089 (View on PubMed)

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.

Reference Type RESULT
PMID: 11283527 (View on PubMed)

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.

Reference Type RESULT
PMID: 15229201 (View on PubMed)

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.

Reference Type RESULT
PMID: 25618113 (View on PubMed)

Other Identifiers

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7-11/62

Identifier Type: -

Identifier Source: org_study_id

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