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Sponsored by: |
Sterling Hospital |
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Information provided by: | Sterling Hospital |
ClinicalTrials.gov Identifier: | NCT00606762 |
The physiological changes and postoperative pain are directly related with the degree of intra-abdominal pressure kept during the laparoscopy. The present study aims to examine difference between low pressure pneumoperitoneum (8 mm Hg)and High pressure pneumoperitoneum (12 mm Hg)during laparoscopic cholecystectomy in terms of pain, cardio-pulmonary function, arterial blood gas changes etc.
Condition | Intervention |
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Cholelithiasis |
Procedure: Laparoscopic cholecystectomy |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Randomized, Controlled Study Comparing Low Pressure Versus High Pressure Pneumoperitoneum During Laparoscopic Cholecystectomy. |
Enrollment: | 26 |
Study Start Date: | October 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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LPLC, HPLC: Active Comparator
LPLC: Low pressure pneumoperitoneum is defined as intraabdominal pressure kept at8 mm Hg after initial trocar insertion at 12 mm Hg HPLC: High pressure pneumoperitoneum is defined as intra abdominal pressure kept at 12 mm Hg throughout the procedure
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Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed at either 8 mm Hg or 12 mm Hg intra-abdominal pressure
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sterling Hospital ( Dr. Vismit P. Joshipura ) |
Study ID Numbers: | 1-Joshipura |
Study First Received: | January 22, 2008 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00606762 History of Changes |
Health Authority: | India: Institutional Review Board |
laparoscopic cholecystectomy low pressure pneumoperitoneum |
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases Cholelithiasis |
Gallstones Biliary Tract Diseases Peritoneal Diseases Calculi Pneumoperitoneum |
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases Cholelithiasis |
Gallstones Biliary Tract Diseases Peritoneal Diseases Calculi Pneumoperitoneum |