Pneumoperitoneum and Gynecological Laparoscopic Surgery: An Observational Clinical Study

NCT03159637 | Completed DMC

• 1 other identifier: IRB000087698
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic surgery is now widely established.Laparoscopic surgery involves insufflation of a gas (usually carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum. The raised intra-abdominal pressure of the pneumoperitoneum, alteration in the patient's position and effects of carbon dioxide absorption cause changes in physiology, especially within the cardiovascular and respiratory systems.

Conditions

Laparoscopy

Keywords

Pneumoperitoneum; Trendelenburg position; intra-abdominal pressure

Outcome Measures

Primary Outcomes (2)

• mean arterial blood pressure

  mean arterial blood pressure will be monitored at different times

  within the duration of the operation

• Pulmonary function tests

  forced expiratory volume at one second

  within the first 24 hours

Secondary Outcomes (5)

• PaO2

  within the first 24 hours

• Arterial to end-tidal PaCO2- difference

  within the first 24 hours

• Intra-abdominal pressure

  within the first 24 hours

• Postoperative nausea and vomiting

  within the first 24 hours

• Analgesic requirement

  within the first 24 hours

Interventions

Laparoscopic Surgery PROCEDURE

Insufflation of a gas (carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum will be done. The positioning of the patients in Trendelenburg position will be done. intraoperative and postoperative outcomes will be assesed

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: female patients only
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

female patients only

You may qualify if:

• Age range 18-50
• ASA 1
• Elective gynecological laparoscopic surgery

You may not qualify if:

• Severe ischemic or valvular heart disease
• Increased intracranial pressure (e.g. Hydrocephalus, Cerebral tumor, Head injury)
• Hepatic or renal impairment
• Emergency surgery
• Open surgery
• Previous abdominal surgery

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sayed K Abd-Elshafy, M.D

  Associate Profossor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profossor

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: May 30, 2017
• Primary Completion: November 12, 2018
• Study Completion: December 1, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

EG (1)