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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transumbilical pneumoperitoneum
Procedure: 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
Procedure: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr Mudassar Saeed Pansota

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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