Cholelithiasis (Without Cholecystitis)NCT07672145
Comparison of Gallbladder Extraction Via Subxiphoid vs Infraumbilical Port in Laparoscopic Cholecystectomy
A study testing Subxiphoid Gallbladder Retrieval and Infraumbilical Gallbladder Extraction in people with Cholelithiasis (Without Cholecystitis) and Cholecystitis, Acute, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease due to its advantages in reducing postoperative pain and recovery times. However, surgeons continue to debate the optimal port site for retrieving the gallbladder specimen from the abdominal cavity, as this choice can… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cholelithiasis (Without Cholecystitis), Cholecystitis, Acute
- What is being tested?
- Subxiphoid Gallbladder Retrieval and Infraumbilical Gallbladder Extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 20 May 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 18 to 60 years.
- Diagnosed with symptomatic gallstones on ultrasonography.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective laparoscopic cholecystectomy.
- Presence of acute or empyematous cholecystitis
Who cannot join
- Intraoperative conversion to open cholecystectomy.
- Diagnosed with Diabetes mellitus type 2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Department of Surgery ,Mayo Hospital
Lahore, Punjab Province, 54000
Dr. Abdur Rehman, MBBS, +92 331 4344 721, Oabdurrehmanazad@gmail.com
Muhammad Zeeshan Sarwar, MBBS,FCPS
About this study
Official title: Comparison of Gallbladder Extraction Via the Subxiphoid Port and the Infraumbilical Port During Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease due to its advantages in reducing postoperative pain and recovery times. However, surgeons continue to debate the optimal port site for retrieving the gallbladder specimen from the abdominal cavity, as this choice can influence wound-related morbidity.
Traditionally, the gallbladder is extracted through the infraumbilical port site. While effective, this route is associated with a potential risk of port-site infections due to bacterial colonization within the umbilicus and risk of contamination during specimen extraction. Retrieving the gallbladder through the subxiphoid port has been proposed as an alternative technique that may utilize a cleaner surgical site, potentially reducing patient pain scores and regional wound complications.
This prospective randomized clinical trial aims to directly compare the clinical outcomes of extracting the gallbladder through the subxiphoid port versus the traditional infraumbilical port. The study will evaluate and compare mean postoperative pain intensity within the first 24 hours, as well as the regional development of port-site infections, seromas, or hematomas within 7 days following elective laparoscopic surgery.
Read the detailed description
This study is structured as a parallel-group randomized controlled trial conducted at Mayo Hospital, Lahore, to evaluate the optimal retrieval site for specimen extraction during elective laparoscopic cholecystectomy.
Eligible patients aged 18 to 60 years diagnosed with symptomatic gallstone disease who meet all predefined inclusion criteria will be invited to participate. All surgical procedures will be standardized and performed under general anesthesia by a senior consultant surgeon using a conventional four-port technique. Following the successful mobilization of the gallbladder, the specimen will be enclosed safely inside a sterile endo-bag to control potential bile contamination.
Patients will then be dynamically allocated via a computer-generated randomization system into one of two surgical groups:
- Group A (Experimental Arm): The endo-bag containing the gallbladder is carefully retrieved through the subxiphoid port site under direct vision.
- Group B (Active Comparator Arm): The endo-bag containing the gallbladder is retrieved through the primary infraumbilical camera port site under direct vision.
Postoperatively, all participating patients will be systematically tracked for primary and secondary outcomes. Postoperative physical distress will be quantified while the patient is at rest using a 10-point Visual Analogue Scale (VAS) at regular intervals of 6, 12, and 24 hours. Additionally, specialized clinical assessments will be performed through the first 7 postoperative days to monitor and log the occurrence of port-site infections, staged using the Southampton Wound Classification system, alongside local complications including seroma or hematoma formation.
Statistical analyses will be executed using SPSS, utilizing independent t-tests for quantitative variables and Chi-square testing for qualitative categorical outcomes to evaluate significance.
- Being tested
- Subxiphoid Gallbladder Retrieval, Infraumbilical Gallbladder Extraction
- Keywords
- Laparoscopic Cholecystectomy, Gallbladder Extraction, Subxiphoid Port, Infraumbilical Port, Postoperative Pain, Port-Site Infection
- Medical subject headings
- Cholelithiasis, Cholecystitis, Acute, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subxiphoid Gallbladder RetrievalProcedure or surgery
Following standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the subxiphoid port site under direct laparoscopic visualization to minimize bile spillage and abdominal wall contamination.
Infraumbilical Gallbladder ExtractionProcedure or surgery
Following standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the primary camera port site at the infraumbilical incision under direct laparoscopic visualization.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Subxiphoid Port Extraction | Experimental | Patients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the subxiphoid port site under direct vision to minimize bile spillage. Receives: Procedure: Subxiphoid Gallbladder Retrieval |
| Group B: Infraumbilical Port Extraction | Active comparator | Patients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the primary infraumbilical (camera) port site under direct vision. Receives: Procedure: Infraumbilical Gallbladder Extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Postoperative Pain Score
Postoperative pain intensity will be assessed while the patient is at rest using a 10-point Visual Analogue Scale (VAS), where 0 represents "No Pain" and 10 represents "Worst Possible Pain".
Measured: At 6, 12, and 24 hours post-surgery
Secondary outcomes (2)
Incidence of Port-Site Infection
The presence and severity of port-site infections will be evaluated and graded according to the objective criteria of the Southampton Wound Classification System (Grades 0 to V)
Measured: Up to 7 postoperative days
Incidence of Local Wound-Related Complications
The development of local wound site complications, specifically tracking the presence or absence of a clinically or ultrasonographically confirmed seroma (clear fluid collection) or hematoma (localized blood collection).
Measured: Up to 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start20 May 2026
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cholelithiasis (Without Cholecystitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Muhammad Zeeshan Sarwar, MBBS,FCPS, Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672145
- Sponsor's protocol ID
- Dr Abdur Rehman
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the primary research team to maintain strict patient confidentiality, as mandated by the Institutional Review Board (IRB) and the Advanced Studies \& Research Board (ASRB) of King Edward Medical University, Lahore. According to the signed institutional data protection affidavit and the informed patient consent protocol, all collected clinical data are strictly restricted for use within this specific postgraduate master's thesis project.
Publications
Li M, Cao B, Gong R, Sun D, Zhang P, Jiang X, Sheng Y. Randomized trial of umbilical incisional hernia in high-risk patients: extraction of gallbladder through subxiphoid port vs. umbilical port after laparoscopic cholecystectomy. Wideochir Inne Tech Maloinwazyjne. 2018 Sep;13(3):342-349. doi: 10.5114/wiitm.2018.76001. Epub 2018 May 25.
PubMed 30302147Sasmal PK, Mishra TS, Rath S, Meher S, Mohapatra D. Port site infection in laparoscopic surgery: A review of its management. World J Clin Cases. 2015 Oct 16;3(10):864-71. doi: 10.12998/wjcc.v3.i10.864.
PubMed 26488021Ye X, Niu X, Bai D, Cao Y, Mao Y, Liu H, Luo Y, Fuyu-Li, Cheng N, You Z. Comparison of gallbladder extraction via the subxiphoid port and the supraumbilical port during laparoscopic cholecystectomy: a prospective randomized clinical trial. Int J Surg. 2025 Jan 1;111(1):628-634. doi: 10.1097/JS9.0000000000001932.
PubMed 40053819Mohamed HK, Albendary M, Wuheb AA, Ali O, Mohammed MJ, Osman M, Elshikhawoda MSM, Mohamedahmed AY. A Systematic Review and Meta-Analysis of Bag Extraction Versus Direct Extraction for Retrieval of Gallbladder After Laparoscopic Cholecystectomy. Cureus. 2023 Feb 26;15(2):e35493. doi: 10.7759/cureus.35493. eCollection 2023 Feb.
PubMed 37007356Hajibandeh S, Hajibandeh S, Clark MC, Barratt OA, Taktak S, Subar D, Henley N. Retrieval of Gallbladder Via Umbilical Versus Epigastric Port Site During Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Surg Laparosc Endosc Percutan Tech. 2019 Oct;29(5):321-327. doi: 10.1097/SLE.0000000000000662.
PubMed 31033631Mannam R, Sankara Narayanan R, Bansal A, Yanamaladoddi VR, Sarvepalli SS, Vemula SL, Aramadaka S. Laparoscopic Cholecystectomy Versus Open Cholecystectomy in Acute Cholecystitis: A Literature Review. Cureus. 2023 Sep 21;15(9):e45704. doi: 10.7759/cureus.45704. eCollection 2023 Sep.
PubMed 37868486Khalid A, Khalil K, Mehmood Qadri H, Ahmad CZ, Fatima W, Raza A, Asif MA, Luqman MS, Jawariah, Nizami MFK. Comparison of Postoperative Complications of Open Versus Laparoscopic Cholecystectomy According to the Modified Clavien-Dindo Classification System. Cureus. 2023 Aug 17;15(8):e43642. doi: 10.7759/cureus.43642. eCollection 2023 Aug.
PubMed 37727181
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gallbladder Extraction Via the Subxiphoid Port and the Infraumbilical Port During Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07672145
- Acronym / sponsor ID
- Dr Abdur Rehman
- Keywords
- Laparoscopic Cholecystectomy, Gallbladder Extraction, Subxiphoid Port, Infraumbilical Port, Postoperative Pain, Port-Site Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease due to its advantages in reducing postoperative pain and recovery times. However, surgeons continue to debate the optimal port site for retrieving the gallbladder specimen from the abdominal cavity, as this choice can influence wound-related morbidity.
Traditionally, the gallbladder is extracted through the infraumbilical port site. While effective, this route is associated with a potential risk of port-site infections due to bacterial colonization within the umbilicus and risk of contamination during specimen extraction. Retrieving the gallbladder through the subxiphoid port has been proposed as an alternative technique that may utilize a cleaner surgical site, potentially reducing patient pain scores and regional wound complications.
This prospective randomized clinical trial aims to directly compare the clinical outcomes of extracting the gallbladder through the subxiphoid port versus the traditional infraumbilical port. The study will evaluate and compare mean postoperative pain intensity within the first 24 hours, as well as the regional development of port-site infections, seromas, or hematomas within 7 days following elective laparoscopic surgery.
Detailed description
This study is structured as a parallel-group randomized controlled trial conducted at Mayo Hospital, Lahore, to evaluate the optimal retrieval site for specimen extraction during elective laparoscopic cholecystectomy.
Eligible patients aged 18 to 60 years diagnosed with symptomatic gallstone disease who meet all predefined inclusion criteria will be invited to participate. All surgical procedures will be standardized and performed under general anesthesia by a senior consultant surgeon using a conventional four-port technique. Following the successful mobilization of the gallbladder, the specimen will be enclosed safely inside a sterile endo-bag to control potential bile contamination.
Patients will then be dynamically allocated via a computer-generated randomization system into one of two surgical groups:
- Group A (Experimental Arm): The endo-bag containing the gallbladder is carefully retrieved through the subxiphoid port site under direct vision.
- Group B (Active Comparator Arm): The endo-bag containing the gallbladder is retrieved through the primary infraumbilical camera port site under direct vision.
Postoperatively, all participating patients will be systematically tracked for primary and secondary outcomes. Postoperative physical distress will be quantified while the patient is at rest using a 10-point Visual Analogue Scale (VAS) at regular intervals of 6, 12, and 24 hours. Additionally, specialized clinical assessments will be performed through the first 7 postoperative days to monitor and log the occurrence of port-site infections, staged using the Southampton Wound Classification system, alongside local complications including seroma or hematoma formation.
Statistical analyses will be executed using SPSS, utilizing independent t-tests for quantitative variables and Chi-square testing for qualitative categorical outcomes to evaluate significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Subxiphoid Port Extraction | Experimental | Procedure: Subxiphoid Gallbladder RetrievalPatients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the subxiphoid port site under direct vision to minimize bile spillage. |
| Group B: Infraumbilical Port Extraction | Active comparator | Procedure: Infraumbilical Gallbladder ExtractionPatients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the primary infraumbilical (camera) port site under direct vision. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients aged between 18 to 60 years.
- Diagnosed with symptomatic gallstones on ultrasonography.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Scheduled for elective laparoscopic cholecystectomy.
- Presence of acute or empyematous cholecystitis
Key exclusion criteria (2 listed)
- Intraoperative conversion to open cholecystectomy.
- Diagnosed with Diabetes mellitus type 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subxiphoid Gallbladder RetrievalFollowing standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the subxiphoid port site under direct laparoscopic visualization to minimize bile spillage and abdominal wall contamination. | Procedure or surgery | Group A: Subxiphoid Port Extraction |
| Infraumbilical Gallbladder ExtractionFollowing standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the primary camera port site at the infraumbilical incision under direct laparoscopic visualization. | Procedure or surgery | Group B: Infraumbilical Port Extraction |
Primary outcome
Mean Postoperative Pain Score
Time frame: At 6, 12, and 24 hours post-surgery
Postoperative pain intensity will be assessed while the patient is at rest using a 10-point Visual Analogue Scale (VAS), where 0 represents "No Pain" and 10 represents "Worst Possible Pain".
2 secondary outcomes
Incidence of Port-Site Infection
Time frame: Up to 7 postoperative days
Incidence of Local Wound-Related Complications
Time frame: Up to 7 postoperative days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 30302147Li M, Cao B, Gong R, Sun D, Zhang P, Jiang X, Sheng Y. Randomized trial of umbilical incisional hernia in high-risk patients: extraction of gallbladder through subxiphoid port vs. umbilical port after laparoscopic cholecystectomy. Wideochir Inne Tech Maloinwazyjne. 2018 Sep;13(3):342-349. doi: 10.5114/wiitm.2018.76001. Epub 2018 May 25.
- Background: PubMed 26488021Sasmal PK, Mishra TS, Rath S, Meher S, Mohapatra D. Port site infection in laparoscopic surgery: A review of its management. World J Clin Cases. 2015 Oct 16;3(10):864-71. doi: 10.12998/wjcc.v3.i10.864.
- Background: PubMed 40053819Ye X, Niu X, Bai D, Cao Y, Mao Y, Liu H, Luo Y, Fuyu-Li, Cheng N, You Z. Comparison of gallbladder extraction via the subxiphoid port and the supraumbilical port during laparoscopic cholecystectomy: a prospective randomized clinical trial. Int J Surg. 2025 Jan 1;111(1):628-634. doi: 10.1097/JS9.0000000000001932.
- Background: PubMed 37007356Mohamed HK, Albendary M, Wuheb AA, Ali O, Mohammed MJ, Osman M, Elshikhawoda MSM, Mohamedahmed AY. A Systematic Review and Meta-Analysis of Bag Extraction Versus Direct Extraction for Retrieval of Gallbladder After Laparoscopic Cholecystectomy. Cureus. 2023 Feb 26;15(2):e35493. doi: 10.7759/cureus.35493. eCollection 2023 Feb.
- Background: PubMed 31033631Hajibandeh S, Hajibandeh S, Clark MC, Barratt OA, Taktak S, Subar D, Henley N. Retrieval of Gallbladder Via Umbilical Versus Epigastric Port Site During Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Surg Laparosc Endosc Percutan Tech. 2019 Oct;29(5):321-327. doi: 10.1097/SLE.0000000000000662.
- Background: PubMed 37868486Mannam R, Sankara Narayanan R, Bansal A, Yanamaladoddi VR, Sarvepalli SS, Vemula SL, Aramadaka S. Laparoscopic Cholecystectomy Versus Open Cholecystectomy in Acute Cholecystitis: A Literature Review. Cureus. 2023 Sep 21;15(9):e45704. doi: 10.7759/cureus.45704. eCollection 2023 Sep.
- Background: PubMed 37727181Khalid A, Khalil K, Mehmood Qadri H, Ahmad CZ, Fatima W, Raza A, Asif MA, Luqman MS, Jawariah, Nizami MFK. Comparison of Postoperative Complications of Open Versus Laparoscopic Cholecystectomy According to the Modified Clavien-Dindo Classification System. Cureus. 2023 Aug 17;15(8):e43642. doi: 10.7759/cureus.43642. eCollection 2023 Aug.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of the primary research team to maintain strict patient confidentiality, as mandated by the Institutional Review Board (IRB) and the Advanced Studies \& Research Board (ASRB) of King Edward Medical University, Lahore. According to the signed institutional data protection affidavit and the informed patient consent protocol, all collected clinical data are strictly restricted for use within this specific postgraduate master's thesis project.
Related trials for Cholelithiasis (Without Cholecystitis)
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Cholecystectomy, Gallbladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Muhammad Zeeshan Sarwar, MBBS,FCPS principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subxiphoid Gallbladder Retrieval and Infraumbilical Gallbladder Extraction in people with Cholelithiasis (Without Cholecystitis) and Cholecystitis, Acute, run by King Edward Medical University 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 5 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: looking for participants now, as of the sponsor's last update on 26 Jun 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Abdur Rehman, MBBS (+92 331 4344721, oabdurrehmanazad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Postoperative Pain Score (time frame: At 6, 12, and 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07672145, which also lists 7 linked publications.
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 26 Jun 2026.