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

Sponsor
Ismet Hortu (Other)
Overall Status
Completed
CT.gov ID
NCT04493983
Collaborator
(none)
30
1
1
12
2.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: laparoscopic salpingo-oophorectomy
  • Procedure: Laparoscopic bilateral salpingo-oophorectomy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Sep 1, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Procedure: laparoscopic salpingo-oophorectomy
Laparoscopic bilateral salpingo-oophorectomy

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University School of Medicine, Department of Obstetrics and Gynecology Izmir Turkey 35100

Sponsors and Collaborators

  • Ismet Hortu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ismet Hortu, Clinical researcher, Ismet Hortu, MD., PhD. Department of Obstetrics and Gynecology, Ege University School of Medicine, Izmir, Turkey, Ege University
ClinicalTrials.gov Identifier:
NCT04493983
Other Study ID Numbers:
  • 7-11/62
First Posted:
Jul 30, 2020
Last Update Posted:
May 25, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 25, 2021