Transumbilical Versus Infraumbilical Pneumoperitoneum in Laparoscopic Cholecystectomy

NCT07601035 | Completed DMC

• 1 other identifier: Pakistan Railways Hospital
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The case study is planned to emanate a comparison between transumbilical pneumoperitoneum and infraumbilical in patients that undergo laparoscopic cholecystectomy. It concentrates on the port access time, events during intraoperative access, postoperative change of events, pain, hospitalization, and cosmetic satisfaction. Through evaluation of both technical and patient centred outcomes, this study can help elucidate on whether transumbilical approach possesses practical benefits compared with its alternative, the conventional method of infraumbilical, without adding risk to the operations. These findings can justify other safer, more efficient and aesthetically correct primary port placement in laparoscopic cholecystectomy.

Conditions

Cholelithiases

Keywords

cholelithiasis; transumbilical; pneumoperitoneum

Outcome Measures

Primary Outcomes (1)

• Percentage of complications

  bleeding, vessel injury, bowel injury

  day 1

Study Arms (2)

Transumbilical pneumoperitoneum

EXPERIMENTAL

Procedure: Transumbilical pneumoperitoneum

Infraumbilical pneumoperitoneum

PLACEBO COMPARATOR

Procedure: Infraumbilical pneumoperitoneum

Interventions

Transumbilical pneumoperitoneum PROCEDURE

In transumbilical group, umbilical cicatrix was incised and primary port was inserted by the use of the transumbilical route to create pneumoperitoneum.

Transumbilical pneumoperitoneum

Infraumbilical pneumoperitoneum PROCEDURE

In the infraumbilical group, a skin incision was made just below the umbilicus, and the primary port was introduced through the infraumbilical route. Another routine surgical procedure at the study center was the creation of a pneumoperitoneum. Once pneumoperitoneum was created successfully, laparoscope was inserted and the rest of ports were done under direct vision as per the traditional laparoscopic cholecystectomy procedure

Infraumbilical pneumoperitoneum

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years) undergoing laparoscopic cholecystectomy for symptomatic gallstone disease (biliary colic, cholecystitis, gallbladder polyps requiring surgery).
• Both elective and emergency laparoscopic cholecystectomy cases.
• Patients of both genders

You may not qualify if:

• Patients with choledocholithiasis, obstructive jaundice, or dilated common bile duct requiring ERCP or alternative interventions.
• Patients undergoing a planned open cholecystectomy

Sponsors & Collaborators

• Dr Mudassar Saeed Pansota: lead

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Cholelithiasis; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Peritoneal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: February 9, 2026
• Primary Completion: May 8, 2026
• Study Completion: May 8, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

PA (1)