ClinicalTrials.Veeva

Menu

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

I

Ismet Hortu

Status

Completed

Conditions

Ischemia Reperfusion Injury
Oxidative Stress
Oophorectomy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04493983
7-11/62

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Investigation
Other group
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.
Treatment:
Procedure: laparoscopic salpingo-oophorectomy
Procedure: Laparoscopic bilateral salpingo-oophorectomy

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems