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

Not Applicable

Completed

• Conditions: Ischemia Reperfusion Injury; Oophorectomy; Oxidative Stress
• Interventions: Procedure: laparoscopic salpingo-oophorectomy; Procedure: Laparoscopic bilateral salpingo-oophorectomy

• Registration Number: NCT04493983
• Lead Sponsor: Ismet Hortu

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-07-30
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-23
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigation	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.
Investigation	laparoscopic 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.

Primary Outcome Measures

Name	Time	Method
Impact of CO2 pneumoperitoneum on ovaries by comparing histopathology	1-day (at the time of the surgery)	Histopathological investigation of ovaries after CO2 pneumoperitoneum -induced I/R

Trial Locations

Locations (1)

Ege University School of Medicine, Department of Obstetrics and Gynecology; 🇹🇷 Izmir, Turkey