Comparison Between Low Pressure Pneumoperitoneum with High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy

NCT06447545 | Recruiting

• 1 other identifier: AAMC/IRB/EA 31 2024
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of pain and common bile duct injuries in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum versus high pressure pneumoperitoneum.

Conditions

Cholecystectomy; Pneumoperitoneum; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• The incidence of pain and common bile duct injury in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum is less versus High pressure pneumoperitoneum.

  Pain will accessed using VAS. Pain (VAS): The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It was assessed at 4, 8, 12 hours post-operatively by using Visual Analogue Pain Scale. No pain \|0\_\_\_\_1\_\_\_\_2\_\_\_\_3\_\_\_\_4\_\_\_\_5\_\_\_\_6\_\_\_\_7\_\_\_\_8\_\_\_\_9\_\_\_\_10\| sever pain Mild pain-Moderate Pain-Sever pain Visual Analogue Pain Scale And CBD injury will be accessed using bismuth classification. CBD INJURY: Injury to CBD Is Classified According to Bismuth Classification: Type I is a low injury with a stump length more than 2 cm. Type II is a middle level injury with a stump length less than 2 cm. Type III is a high-level injury without common hepatic duct available but preserved confluence. Type IV involves loss of hepatic confluence with no communication between right and left ducts.

  6 months

Study Arms (2)

Low Pressure Pneumoperitoneum

OTHER

low-pressure pneumoperitoneum in which the pressure is (6-10 mmHg)

Device: Changing pressure of Pneumoperitoneum to 6-10 mmHg

High Pressure Pneumoperitoneum

OTHER

High-pressure pneumoperitoneum, involving insufflation pressures typically ranging from 12 to 15 mmHg or higher

Device: Changing pressure of Pneumoperitoneum to 12-15 mmHg

Interventions

Changing pressure of Pneumoperitoneum to 6-10 mmHg DEVICE

Result of changing pneumoperitoneum pressure on CBD injury and pain

Also known as: Low Pressure Pneumoperitoneum

Low Pressure Pneumoperitoneum

Changing pressure of Pneumoperitoneum to 12-15 mmHg DEVICE

Result of changing pneumoperitoneum pressure on CBD injury and pain

Also known as: High Pressure Pneumoperitoneum

High Pressure Pneumoperitoneum

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from both genders
• Patients undergoing laparoscopic cholecystectomy for cholelithiasis.

You may not qualify if:

• Patients with cardiac abnormalities.
• Patients with previous abdominal surgeries.

Sponsors & Collaborators

• Gulab Devi Hospital: lead

Study Sites (1)

Gulab Devi Hospital

Lahore, PUN, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum; Pain, Postoperative

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• M. Zia-ul-Miraj Ahmad, MBBS,FRCS

  Gulab Devi Hospital

  STUDY DIRECTOR

Central Study Contacts

Zain Himayoun, MBBS

CONTACT

03043862033; zain.1080@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: June 7, 2024
• Study Start: May 19, 2024
• Primary Completion: May 19, 2024
• Study Completion: November 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-06

Locations

PA (1)