Effect of Pneumoperitoneum on Human Ovary

NCT02731651 | Completed DMC

• 1 other identifier: AAkdemir2
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Study Arms (2)

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.

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.

Procedure: laparoscopic assisted vaginal hysterectomy

Interventions

open hysterectomy PROCEDURE

Hysterectomy with laparotomy incision.

Open Hysterectomy

laparoscopic assisted vaginal hysterectomy PROCEDURE

Hysterectomy with laparoscopic assisstance.

LaparoscopicAssistedVaginalHysterectomy

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with an indication of hysterectomy with benign uterine pathology

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 7, 2016
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 12, 2016

Record last verified: 2016-04