Reperfusion InjuryNCT02731651
Effect of Pneumoperitoneum on Human Ovary
A study testing open hysterectomy and laparoscopic assisted vaginal hysterectomy in people with Reperfusion Injury, run by Ege University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Reperfusion Injury
- What is being tested?
- open hysterectomy and laparoscopic assisted vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with an indication of hysterectomy with benign uterine pathology
Who cannot join
- 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.
About this study
Official title: Effect of CO2 Pneumoperitoneum on Human Ovary: Preliminary Study
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.
Read the 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.
- Conditions
- Reperfusion Injury
- Being tested
- open hysterectomy, laparoscopic assisted vaginal hysterectomy
- Medical subject headings
- Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open hysterectomyProcedure or surgery
Hysterectomy with laparotomy incision.
laparoscopic assisted vaginal hysterectomyProcedure or surgery
Hysterectomy with laparoscopic assisstance.
| Study group | Role | What they receive |
|---|---|---|
| Open Hysterectomy | Active comparator | 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. Receives: Procedure: open hysterectomy |
| LaparoscopicAssistedVaginalHysterectomy | Active comparator | 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. Receives: Procedure: laparoscopic assisted vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Akdemir, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731651
- Sponsor's protocol ID
- AAkdemir2
- Status last verified
- Apr 2016
- First submitted
- 23 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CO2 Pneumoperitoneum on Human Ovary: Preliminary Study
- ClinicalTrials.gov ID
- NCT02731651
- Acronym / sponsor ID
- AAkdemir2
- Conditions
- Reperfusion Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Hysterectomy | Active comparator | Procedure: open hysterectomyOpen hysterectomy was performed with taking one of the ovaries at the beginning and the other ovary was removed at the end of the surgery. |
| LaparoscopicAssistedVaginalHysterectomy | Active comparator | Procedure: laparoscopic assisted vaginal hysterectomySurgery 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with an indication of hysterectomy with benign uterine pathology
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open hysterectomyHysterectomy with laparotomy incision. | Procedure or surgery | Open Hysterectomy |
| laparoscopic assisted vaginal hysterectomyHysterectomy with laparoscopic assisstance. | Procedure or surgery | LaparoscopicAssistedVaginalHysterectomy |
Primary outcome
Evaluating the ischemia reperfusion injury related to pneumoperitoneum on human ovary.
Time frame: 1 day
Ischemia reperfusion injury was evaluated with histopathological assessment, and with assessing ovarian tissue malondialdehyde levels biochemically.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing open hysterectomy and laparoscopic assisted vaginal hysterectomy in people with Reperfusion Injury, run by Ege University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the ischemia reperfusion injury related to pneumoperitoneum on human ovary. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.