Transumbilical Versus Infraumbilical Pneumoperitoneum in Laparoscopic Cholecystectomy

May 20, 2026 updated by: Dr Mudassar Saeed Pansota

Transumbilical Versus Infraumbilical Pneumoperitoneum in Laparoscopic Cholecystectomy a Comparative Study

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.

Study Overview

Detailed Description

The recognized standard care surgical therapy of symptomatic case of gallstone disease is laparoscopic cholecystectomy due to the provision of smaller wounds, lesser postoperative pain, happen faster to mobilize, hospital stay, and speedy restoration to usual activity relative to open surgery. Although this has these benefits, the process does not go without morbidity. They may occur when dissecting the gallbladder, clipping, cystous structures, extracting the specimen or sewing wounds of trocar but one of the most severe scenarios occurs when entering the peritoneal cavity and the formation of pneumoperitoneum. This is performed before direct intraperitoneal visualization is fully matured and, due to this, is prone to the problems of access, such as bowel trauma, vascular trauma, inability to enter and extraperitoneal incontinence, loss of gases, subcutaneous emphysema, postoperative bleeding and associated wound morbidity.

Safety of pneumoperitoneum safe creation has been a key issue in laparoscopic surgery. Various methods such as the closed Veress needle, open Hassan, optical trocar insertion and direct trocar access have been performed with mixed outcomes. In laparoscopic cholecystectomy, the main entry point is most frequently located at or around the umbilicus due to the access point being central, the abdominal wall is isotomically thin and the location of the cosmetically acceptable scar is located. Nevertheless, the exact site of umbilical access varies among surgeons. Clinical practice with infraumbilical, supraumbilical, periumbilical, and transumbilical is common, mostly depending on the preferences of the surgeon, the body habitus of the patient or any surgical history, and common institutional routine.

Infraumbilical type has long been popular as the initial mode of port insertion as it is common, technically easy and well taught. It can however leave a visible scar beneath the umbilicus and can be correlated with port-site bleeding, infection, hematoma, seroma, pain and hernia. There is clinical significance in port-site morbidity as it may influence recovery, patient satisfaction, visits to the hospital, antibiotic usage, and quality of life in the long run.6 Most port-site complications are harmless, but trocar-site hernia deserves attention since it can manifest itself late and in some cases necessitate operative intervention. There is recent evidence that site of extraction of the specimen can also contribute to the risk of trocar-site hernia, particularly in cases where the umbilical port is extended during gallbladder removal.

Due to its ability to utilise the natural umbilical depression, the transumbilical approach has become of growing interest as the surgical scar can be hidden within the umbilicus. This can enhance the cosmetic satisfaction which is a well-known patient-centered outcome in minimally invasive surgery. Transumbilical could also offer an alternative path through the most flakey section of the anterior abdominal wall and may help to decrease the number of other apparent cuts. Recent prospective trials of transumbilical and single-incision laparoscopic cholecystectomy have documented positive cosmetic and acceptable safety, and possibly advantages of postoperative recovery when carried out on trained surgeons. Nonetheless, these benefits need to be offset against potential issues like crowding of instruments, wound infection, umbilical pain, and incisional hernia threat.

The evaluation of transumbilical versus infraumbilical pneumoperitoneum presently compared is thus applicable in the aspects of safety in surgery as also patient satisfaction. Although serious complications remain rare, even minor variations in access time, gas leakage, bleeding, postoperative pain, infection or scar satisfaction can be significant since laparoscopic cholecystectomy can and often is practiced worldwide. Existing literature has compared open and closed entry methods, single incision with the traditional laparoscopic cholecystectomy entry methods, and transumbilical incision and periumbilical access but there is limited evidence comparing transumbilical and infraumbilical access when applied to routine laparoscopic cholecystectomy procedures.2,4,8 Furthermore, the results can be variable as they depend on patient features in a local area, experience of the surgeon, emergency or elective operation, and perioperative procedures.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 60000
        • Pakistan Railway Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transumbilical pneumoperitoneum
In transumbilical group, umbilical cicatrix was incised and primary port was inserted by the use of the transumbilical route to create pneumoperitoneum.
Placebo Comparator: Infraumbilical pneumoperitoneum
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of complications
Time Frame: day 1
bleeding, vessel injury, bowel injury
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2026

Primary Completion (Actual)

May 8, 2026

Study Completion (Actual)

May 8, 2026

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Pakistan Railways Hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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