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CholelithiasesNCT07601035

Transumbilical Versus Infraumbilical Pneumoperitoneum in Laparoscopic Cholecystectomy

A study testing Transumbilical pneumoperitoneum and Infraumbilical pneumoperitoneum in people with Cholelithiases, run by Dr Mudassar Saeed Pansota at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cholelithiases
What is being tested?
Transumbilical pneumoperitoneum and Infraumbilical pneumoperitoneum
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
125 participants
Where
1 sitePakistan
Study dates
9 Feb 2026to 8 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Pakistan Railway Hospital

    Rawalpindi, Punjab Province, 60000

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Conditions
Cholelithiases
Being tested
Transumbilical pneumoperitoneum, Infraumbilical pneumoperitoneum
Keywords
cholelithiasis, transumbilical, pneumoperitoneum
Medical subject headings
Cholelithiasis, Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transumbilical pneumoperitoneumProcedure or surgery

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

  • Infraumbilical pneumoperitoneumProcedure or surgery

    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

Study groups in NCT07601035
Study groupRoleWhat they receive
Transumbilical pneumoperitoneumExperimentalNot described
Receives: Procedure: Transumbilical pneumoperitoneum
Infraumbilical pneumoperitoneumPlacebo comparatorNot described
Receives: Procedure: Infraumbilical pneumoperitoneum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of complications

    bleeding, vessel injury, bowel injury

    Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start9 Feb 2026
  3. Primary completion8 May 2026
  4. Study completion8 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07601035
Sponsor's protocol ID
Pakistan Railways Hospital
Status last verified
May 2026
First submitted
15 May 2026
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transumbilical pneumoperitoneum and Infraumbilical pneumoperitoneum in people with Cholelithiases, run by Dr Mudassar Saeed Pansota at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of complications (time frame: day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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