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Effect of Pneumoperitoneum on Human Ovary

Primary Purpose

Reperfusion Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
open hysterectomy
laparoscopic assisted vaginal hysterectomy
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Reperfusion Injury

Eligibility Criteria

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with an indication of hysterectomy with benign uterine pathology

Exclusion Criteria:

  • patients with cardio vascular, pulmonary , hepatic or renal dysfunction,
  • previous abdominal surgery,
  • morbid obesity,
  • intraabdominal adhesions preventing removal of the first ovary in a few minutes,
  • any ovarian disease,
  • current smoker, and
  • refusal to participation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Open Hysterectomy

    LaparoscopicAssistedVaginalHysterectomy

    Arm Description

    Open hysterectomy was performed with taking one of the ovaries at the beginning and the other ovary was removed at the end of the surgery.

    Surgery in Group 2 (LAVH): Laparoscopic Assisted Vaginal Hysterectomy was performed with taking one of the ovary at the beginning of the procedure and the other ovary was removed at the end of the surgery.

    Outcomes

    Primary Outcome Measures

    Evaluating the ischemia reperfusion injury related to pneumoperitoneum on human ovary.
    Ischemia reperfusion injury was evaluated with histopathological assessment, and with assessing ovarian tissue malondialdehyde levels biochemically.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2016
    Last Updated
    April 8, 2016
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02731651
    Brief Title
    Effect of Pneumoperitoneum on Human Ovary
    Official Title
    Effect of CO2 Pneumoperitoneum on Human Ovary: Preliminary Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ege University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Laparoscopic surgery has played a pivotal role in all surgical fields in modern medicine. It has some well known advantages over open surgery. For this reason laparoscopic surgery is know the first choice for many surgical procedures, even in gynecology. On the other hand, despite the advantages of laparoscopy carbon dioxide (CO2) pneumoperitoneum is not free from side effects. Experimental studies and limited clinical studies showed that pneumoperitoneum leads to a decrease in the blood flow to intra-abdominal organs during laparoscopic surgery. This is also known as ischemia, leads to the production of free O2 radicals. The desufflation of the abdominal cavity at the end of the procedure reduces the increased abdominal pressure and increase the perfusion of intra-abdominal organs. However this will not stop the production of free radicals. This reperfusion period even exaggerate the release of free radicals. This phenomenon is called as ischemia/reperfusion (I/R) model that leads to release of various free radicals, which are the most important mediators of oxidative tissue injury and consequential organ dysfunction. Recently both oxidative tissue injury and consequential dysfunction have been shown in ovarian tissue in experimental animal studies. But the data related to human ovary is still scarce. Thus the aim of the study is to evaluate the effect of I/R injury related to CO2 pneumoperitoneum on human ovary.
    Detailed Description
    Twenty patients at premenopausal period and with an indication of hysterectomy with benign uterine pathology were included in the study. Patients were randomly assigned to open hysterectomy (group 1) and laparoscopic assisted vaginal hysterectomy (group 2). In all patients, surgeries were performed under endotracheal general anesthesia with mechanical ventilation. Under the general anesthesia Arterial blood gas, airway pressure, dynamic pulmonary compliance, peripheral pulse-oximetry, end tidal carbon dioxide pressure level (set at between 35 and 45 mm/hg), blood pressure, and cardiac rhythm were monitored continuously during the surgery. All patients received a single dose of cefazolin sodium as a prophylactic antibiotic. Low molecular weight heparin was not given the patients. Surgery in Group 1 (open hysterectomy) After the induction of the anesthesia and before the skin incision first venous blood sample was collected. Abdominal access was performed with Pfannenstiel incision. One of the ovaries was excised at the initial step. Contralateral utero-ovarian ligament and bilateral round ligaments were then ligated and transected. After the identification of the anterior and posterior leaves of the broad ligament, bladder flap was developed and bladder was moved off the lower uterine segment. Bilateral vascular uterine pedicles, and sacro uterine ligaments were ligated and transected. After performing circumferential colpotomy vaginal cuff was closed. At the final step, before closing the abdominal incision contralateral ovary was excised. Both ovaries were macroscopically evaluated by an expert pathologist immediately after their excision. Before the preparation of the ovaries for histopathological evaluation, 1 cm3 piece of each ovary was excised for biochemical evaluation of the malondialdehyde (MDA) level. Second blood sample was collected immediately after the skin closure. Surgery in Group 2 (LAVH) After the induction of the general anesthesia and before skin incision first venous blood sample was collected from the patients. This blood sample was reflected the baseline status. After umbilical skin incision was made, pneumoperitoneum was created via veress needle using a nonheated (room temperature) and dry CO2. A 10 mm trocar was then inserted into the abdominal cavity through umbilical incision for optic system. Three 5 mm ancillary trocars were then inserted under direct vision. Two were in lower abdominal quadrants and one on the left side of the umbilicus. Intraabdominal pressure (IAP) pressure was set at 14 mmHg and maintained. Immediately after the port placement one of the ovaries was excised in a few minutes. Surgery was continued with ligating and transecting contralateral utero-ovarian ligament and bilateral round ligaments. (Contralateral infundibulopelvic ligament (IP), which contains the main vascular supply of the ovary, was not ligated and transected at this step, ligating and transecting of the IP was performed at the end of the procedure.) Anterior and posterior leaves of the broad ligaments were then identified and bladder flap was developed and the bladder was mobilized off the lower uterine segment. At this point pneumoperitoneum was released and the surgical team performed the rest of the procedure vaginally. Before releasing the pneumoperitoneum second blood sample was collected to reflecting the ischemic status. Circumferential colpotomy was performed and bilateral sacro-uterine ligaments and uterine vascular pedicles were ligated and transected vaginally. Vaginal cuff was closed vaginally. At this point pneumoperitoneum was achieved again to excise the contralateral ovary in a few minutes. Before pneumoperitoneum was performed again third blood sample was collected to represent the reperfusion status. Both ovaries were macroscopically evaluated by an expert pathologist immediately after their excision. Before the preparation of the ovaries for histopathological evaluation, 1 cm3 piece of each ovary was excised for biochemical evaluation of the malondialdehyde (MDA) level. In this group, the first excised ovary represented the baseline status, and the other ovary (excised at the end of the procedure) was exposed to the ischemia and reperfusion condition and represented the I/R status. Plasma MDA and 8-hydroxy-2' -deoxyguanosine (8OHdG) was measured as a marker of oxidative stress. Ovarian tissue MDA level was also measured as a marker of tissue oxidative stress. Besides, ovarian histopathological examination was performed to score the oxidative stress.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reperfusion Injury

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open Hysterectomy
    Arm Type
    Active Comparator
    Arm Description
    Open hysterectomy was performed with taking one of the ovaries at the beginning and the other ovary was removed at the end of the surgery.
    Arm Title
    LaparoscopicAssistedVaginalHysterectomy
    Arm Type
    Active Comparator
    Arm Description
    Surgery in Group 2 (LAVH): Laparoscopic Assisted Vaginal Hysterectomy was performed with taking one of the ovary at the beginning of the procedure and the other ovary was removed at the end of the surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    open hysterectomy
    Intervention Description
    Hysterectomy with laparotomy incision.
    Intervention Type
    Procedure
    Intervention Name(s)
    laparoscopic assisted vaginal hysterectomy
    Intervention Description
    Hysterectomy with laparoscopic assisstance.
    Primary Outcome Measure Information:
    Title
    Evaluating the ischemia reperfusion injury related to pneumoperitoneum on human ovary.
    Description
    Ischemia reperfusion injury was evaluated with histopathological assessment, and with assessing ovarian tissue malondialdehyde levels biochemically.
    Time Frame
    1 day

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with an indication of hysterectomy with benign uterine pathology Exclusion Criteria: patients with cardio vascular, pulmonary , hepatic or renal dysfunction, previous abdominal surgery, morbid obesity, intraabdominal adhesions preventing removal of the first ovary in a few minutes, any ovarian disease, current smoker, and refusal to participation.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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