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

NCT04493983 | Completed DMC

• 1 other identifier: 7-11/62
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oophorectomy; Oxidative Stress; Ischemia Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• Impact of CO2 pneumoperitoneum on ovaries by comparing histopathology

  Histopathological investigation of ovaries after CO2 pneumoperitoneum -induced I/R

  1-day (at the time of the surgery)

Study Arms (1)

Investigation

OTHER

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.

Procedure: laparoscopic salpingo-oophorectomy; Procedure: Laparoscopic bilateral salpingo-oophorectomy

Interventions

laparoscopic salpingo-oophorectomy PROCEDURE

Laparoscopic bilateral salpingo-oophorectomy

Investigation

Laparoscopic bilateral salpingo-oophorectomy 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.

Investigation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ismet Hortu: lead

Study Sites (1)

Ege University School of Medicine, Department of Obstetrics and Gynecology

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 19081089 RESULT

• 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.

  PMID: 11283527 RESULT

• 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.

  PMID: 15229201 RESULT

• 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.

  PMID: 25618113 RESULT

• 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.

  PMID: 29107119 RESULT

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical researcher, Ismet Hortu, MD., PhD. Department of Obstetrics and Gynecology, Ege University School of Medicine, Izmir, Turkey

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 30, 2020
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 25, 2021

Record last verified: 2021-05

Locations

TU (1)