CholelithiasisTPE-LCNCT07595692
Tri-Radial Port Extension for Difficult Gallbladder Extraction
A study testing Vertical Fascial Extension, Horizontal Fascial Extension and Tri-Radial Fascial Micro-Incision in people with Cholelithiasis and Difficult Gallbladder Extraction, run by Bangladesh Navy at 1 site in Bangladesh.
Trial summary
Laparoscopic cholecystectomy is a common operation for gallbladder stones. In some patients, the removed gallbladder is difficult to extract through the umbilical port because it is large, thick-walled, or packed with stones. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholelithiasis, Difficult Gallbladder Extraction, Laparoscopic Cholecystectomy Surgery
- What is being tested?
- Vertical Fascial Extension, Horizontal Fascial Extension and Tri-Radial Fascial Micro-Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteBangladesh
- Study dates
- 22 Jan 2024to 27 Apr 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 aged 18 to 70 years.
- Patients undergoing laparoscopic cholecystectomy for benign gallbladder disease.
- Intraoperatively confirmed difficult gallbladder extraction through the umbilical port site.
- Difficult extraction due to large gallbladder size, thickened gallbladder wall, large stone, multiple packed stones, or resistance at the fascial level.
- Patients willing to participate and provide written informed consent.
- Patients willing to attend follow-up for assessment of port-site complications and hernia.
Who cannot join
- Conversion to open cholecystectomy before gallbladder extraction.
- Suspected or confirmed gallbladder malignancy.
- Uncorrected coagulopathy.
- Pregnancy.
- Previous major midline abdominal surgery affecting the umbilical port site.
- Uncontrolled gallbladder perforation or major stone spillage before extraction.
- Refusal to provide informed consent.
- Inability or unwillingness to complete follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tri-Radial Fascial Micro-Incision Technique for Difficult Gallbladder Extraction During Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
Laparoscopic cholecystectomy is a common operation for gallbladder stones. In some patients, the removed gallbladder is difficult to extract through the umbilical port because it is large, thick-walled, or packed with stones. Surgeons commonly enlarge the fascial opening either vertically or horizontally to remove the specimen. These extensions may cause bleeding, tissue trauma, pain, and possible port-site complications.
This study compares three methods of enlarging the umbilical fascial opening during difficult gallbladder extraction: vertical fascial extension, horizontal fascial extension, and a new tri-radial fascial micro-incision technique called Tareq's Port Extension (TPE). In TPE, three small radial cuts are made around the fascial opening to create a controlled expansion and facilitate extraction.
The study aims to determine whether TPE reduces extraction difficulty, extraction-site bleeding, extraction time, postoperative pain, and port-site complications compared with conventional vertical and horizontal fascial extension techniques. Patients will also be followed for 12 months to assess port-site hernia.
Read the detailed description
This is a prospective, randomized, three-arm interventional study conducted at BNS PATENGA Hospital, Bangladesh Navy. The study evaluates a tri-radial fascial micro-incision technique for difficult gallbladder extraction during laparoscopic cholecystectomy.
During laparoscopic cholecystectomy, the gallbladder is usually removed through a 10 mm umbilical port. In some cases, extraction becomes difficult because of a large gallbladder, thick gallbladder wall, large stone, or multiple packed stones. When the gallbladder cannot pass smoothly through the port, surgeons often enlarge the fascial opening. Conventional methods include vertical or horizontal fascial extension. However, these techniques may be associated with bleeding, irregular tissue tearing, increased pain, and port-site complications.
The intervention being studied is the Tri-Radial Fascial Micro-Incision Technique, also designated as Tareq's Port Extension (TPE). In this technique, instead of extending the fascial opening in one linear direction, three small radial micro-incisions are made around the existing umbilical fascial defect. These small cuts are placed approximately at the 12, 4, and 8 o'clock positions and are kept within the linea alba. The purpose is to create a controlled cloverleaf-shaped expansion of the fascial opening, allowing easier gallbladder extraction while minimizing tissue trauma.
Participants with intraoperatively confirmed difficult gallbladder extraction are randomized into one of three groups:
Vertical fascial extension Horizontal fascial extension Tri-radial fascial micro-incision technique / Tareq's Port Extension
The primary outcomes are extraction time and extraction-site bleeding severity, categorized as minimal, moderate, or profuse. Secondary outcomes include fascial extension length, postoperative pain score, analgesic requirement, port-site infection, hematoma, seroma, clip dislodgement, and port-site hernia at 12 months.
The study is designed to assess whether TPE provides a safer, faster, and more controlled method of gallbladder extraction compared with conventional fascial extension techniques. The technique does not require any special device or additional costly equipment and may be useful in routine laparoscopic surgical practice, especially in settings where commercial specimen retrieval systems are not consistently available or reliable.
- Conditions
- Cholelithiasis, Difficult Gallbladder Extraction, Laparoscopic Cholecystectomy Surgery, Port-Site Fascial Extension
- Being tested
- Vertical Fascial Extension, Horizontal Fascial Extension, Tri-Radial Fascial Micro-Incision
- Keywords
- Laparoscopic cholecystectomy, gallbladder extraction, Tri-radial fascial micro-incision, Tareq's Port Extension, port-site extension, fascial extension, port-site hernia, gallstone disease
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical Fascial ExtensionProcedure or surgery
Conventional vertical extension of the umbilical fascial opening during difficult gallbladder extraction in laparoscopic cholecystectomy. The fascial defect is extended vertically in the midline as required to allow extraction of a large or stone-filled gallbladder specimen.
Horizontal Fascial ExtensionProcedure or surgery
Conventional horizontal extension of the umbilical fascial opening during difficult gallbladder extraction in laparoscopic cholecystectomy. The fascial defect is extended transversely as required to facilitate removal of a large or stone-filled gallbladder specimen.
Tri-Radial Fascial Micro-IncisionProcedure or surgery
Tri-radial fascial micro-incision technique used during difficult gallbladder extraction in laparoscopic cholecystectomy. Three small radial fascial micro-incisions are made around the umbilical fascial opening, approximately at the 12, 4, and 8 o'clock positions, to create controlled expansion and facilitate specimen extraction.
| Study group | Role | What they receive |
|---|---|---|
| Vertical Fascial Extension | Active comparator | Participants assigned to this arm undergo conventional vertical extension of the umbilical fascial opening when gallbladder extraction is difficult during laparoscopic cholecystectomy. The fascial opening is extended vertically in the midline as required to facilitate specimen extraction. Receives: Procedure: Vertical Fascial Extension |
| Horizontal Fascial Extension | Active comparator | Participants assigned to this arm undergo conventional horizontal extension of the umbilical fascial opening when gallbladder extraction is difficult during laparoscopic cholecystectomy. The fascial opening is extended transversely as required to facilitate specimen extraction. Receives: Procedure: Horizontal Fascial Extension |
| Tri-Radial Fascial Micro-Incision | Experimental | Participants assigned to this arm undergo the tri-radial fascial micro-incision technique, also designated Tareq's Port Extension. Three small radial fascial micro-incisions are made around the umbilical fascial opening to create controlled expansion and facilitate difficult gallbladder extraction. Receives: Procedure: Tri-Radial Fascial Micro-Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extraction-Site Bleeding Severity
Severity of bleeding from the umbilical fascial extraction site during difficult gallbladder extraction. Bleeding will be categorized as minimal, moderate, or profuse. Minimal bleeding is defined as no active bleeding or minor oozing controlled with simple pressure or brief cautery. Moderate bleeding is defined as bleeding requiring additional hemostatic intervention but not causing major operative interruption. Profuse bleeding is defined as brisk bleeding requiring prolonged hemostatic effort, suturing, or significant interruption of specimen extraction.
Measured: Intraoperative, during gallbladder specimen extraction
Specimen Extraction Time
Time required to extract the gallbladder specimen after confirmation of difficult extraction and initiation of fascial extension technique. Time will be measured in minutes from the start of fascial extension to complete removal of the gallbladder specimen through the umbilical port site.
Measured: Intraoperative, during gallbladder specimen extraction
Secondary outcomes (6)
Fascial Extension Length
Total length of fascial extension required to complete difficult gallbladder extraction through the umbilical port site, measured in millimeters.
Measured: Intraoperative, immediately after specimen extraction
Postoperative Pain Score
Postoperative pain at the umbilical port site measured using a visual analog scale, where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: 24 hours after surgery
Analgesic Requirement
Number of doses of postoperative analgesic medication required during the first 24 hours after surgery.
Measured: Within 24 hours after surgery
Port-Site Wound Complications
Occurrence of port-site wound complications including surgical site infection, seroma, hematoma, or wound discharge at the umbilical extraction site.
Measured: Up to 30 days after surgery
Cystic Duct Clip Dislodgement
Occurrence of cystic duct clip displacement or dislodgement during gallbladder extraction.
Measured: Intraoperative, during gallbladder specimen extraction
Port-Site Hernia
Occurrence of clinically detected or ultrasound-confirmed hernia at the umbilical extraction port site
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start22 Jan 2024
- Primary completion28 Apr 2025
- Study completion27 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies 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
- Model description
- Participants with intraoperatively confirmed difficult gallbladder extraction during laparoscopic cholecystectomy are randomized in a 1:1:1 ratio into three parallel intervention arms: vertical fascial extension, horizontal fascial extension, and tri-radial fascial micro-incision technique/Tareq's Port Extension. Outcomes are compared among the three groups.
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Navy
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammad Tarequl Islam, Bangladesh Navy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595692
- Sponsor's protocol ID
- BNSP-TPE-LC-2024-001
- Acronym
- TPE-LC
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results may be shared upon reasonable request after publication of the main study results. Data will include demographic variables, operative findings, allocated intervention, primary outcome measures, secondary outcome measures, and follow-up data relevant to port-site complications and hernia. No directly identifiable patient information will be shared.
Publications
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
PubMed 20332511Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Open Med. 2010;4(1):e60-8. Epub 2010 Mar 24. No abstract available.
PubMed 21686296Owens M, Barry M, Janjua AZ, Winter DC. A systematic review of laparoscopic port site hernias in gastrointestinal surgery. Surgeon. 2011 Aug;9(4):218-24. doi: 10.1016/j.surge.2011.01.003. Epub 2011 Feb 1.
PubMed 21672662Swank HA, Mulder IM, la Chapelle CF, Reitsma JB, Lange JF, Bemelman WA. Systematic review of trocar-site hernia. Br J Surg. 2012 Mar;99(3):315-23. doi: 10.1002/bjs.7836. Epub 2011 Dec 30.
PubMed 22213083Comajuncosas J, Hermoso J, Jimeno J, Gris P, Orbeal R, Cruz A, Pares D. Effect of bag extraction to prevent wound infection on umbilical port site wound on elective laparoscopic cholecystectomy: a prospective randomised clinical trial. Surg Endosc. 2017 Jan;31(1):249-254. doi: 10.1007/s00464-016-4965-z. Epub 2016 May 13.
PubMed 27177957La Regina D, Mongelli F, Cafarotti S, Saporito A, Ceppi M, Di Giuseppe M, Ferrario di Tor Vajana A. Use of retrieval bag in the prevention of wound infection in elective laparoscopic cholecystectomy: is it evidence-based? A meta-analysis. BMC Surg. 2018 Nov 19;18(1):102. doi: 10.1186/s12893-018-0442-z.
PubMed 30453917Majid MH, Meshkat B, Kohar H, El Masry S. Specimen retrieval during elective laparoscopic cholecystectomy: is it safe not to use a retrieval bag? BMC Surg. 2016 Sep 19;16(1):64. doi: 10.1186/s12893-016-0181-y.
PubMed 27643488Southern Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies. N Engl J Med. 1991 Apr 18;324(16):1073-8. doi: 10.1056/NEJM199104183241601.
PubMed 1826143Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
PubMed 8000648
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tri-Radial Fascial Micro-Incision Technique for Difficult Gallbladder Extraction During Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07595692
- Acronym / sponsor ID
- TPE-LC / BNSP-TPE-LC-2024-001
- Conditions
- Cholelithiasis, Difficult Gallbladder Extraction, Laparoscopic Cholecystectomy Surgery, Port-Site Fascial Extension
- Keywords
- Laparoscopic cholecystectomy, gallbladder extraction, Tri-radial fascial micro-incision, Tareq's Port Extension, port-site extension, fascial extension, port-site hernia, gallstone disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Bangladesh NavyOther government
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 27 Apr 2026 (actual)
- First posted
- 19 May 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 a common operation for gallbladder stones. In some patients, the removed gallbladder is difficult to extract through the umbilical port because it is large, thick-walled, or packed with stones. Surgeons commonly enlarge the fascial opening either vertically or horizontally to remove the specimen. These extensions may cause bleeding, tissue trauma, pain, and possible port-site complications.
This study compares three methods of enlarging the umbilical fascial opening during difficult gallbladder extraction: vertical fascial extension, horizontal fascial extension, and a new tri-radial fascial micro-incision technique called Tareq's Port Extension (TPE). In TPE, three small radial cuts are made around the fascial opening to create a controlled expansion and facilitate extraction.
The study aims to determine whether TPE reduces extraction difficulty, extraction-site bleeding, extraction time, postoperative pain, and port-site complications compared with conventional vertical and horizontal fascial extension techniques. Patients will also be followed for 12 months to assess port-site hernia.
Detailed description
This is a prospective, randomized, three-arm interventional study conducted at BNS PATENGA Hospital, Bangladesh Navy. The study evaluates a tri-radial fascial micro-incision technique for difficult gallbladder extraction during laparoscopic cholecystectomy.
During laparoscopic cholecystectomy, the gallbladder is usually removed through a 10 mm umbilical port. In some cases, extraction becomes difficult because of a large gallbladder, thick gallbladder wall, large stone, or multiple packed stones. When the gallbladder cannot pass smoothly through the port, surgeons often enlarge the fascial opening. Conventional methods include vertical or horizontal fascial extension. However, these techniques may be associated with bleeding, irregular tissue tearing, increased pain, and port-site complications.
The intervention being studied is the Tri-Radial Fascial Micro-Incision Technique, also designated as Tareq's Port Extension (TPE). In this technique, instead of extending the fascial opening in one linear direction, three small radial micro-incisions are made around the existing umbilical fascial defect. These small cuts are placed approximately at the 12, 4, and 8 o'clock positions and are kept within the linea alba. The purpose is to create a controlled cloverleaf-shaped expansion of the fascial opening, allowing easier gallbladder extraction while minimizing tissue trauma.
Participants with intraoperatively confirmed difficult gallbladder extraction are randomized into one of three groups:
Vertical fascial extension Horizontal fascial extension Tri-radial fascial micro-incision technique / Tareq's Port Extension
The primary outcomes are extraction time and extraction-site bleeding severity, categorized as minimal, moderate, or profuse. Secondary outcomes include fascial extension length, postoperative pain score, analgesic requirement, port-site infection, hematoma, seroma, clip dislodgement, and port-site hernia at 12 months.
The study is designed to assess whether TPE provides a safer, faster, and more controlled method of gallbladder extraction compared with conventional fascial extension techniques. The technique does not require any special device or additional costly equipment and may be useful in routine laparoscopic surgical practice, especially in settings where commercial specimen retrieval systems are not consistently available or reliable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants with intraoperatively confirmed difficult gallbladder extraction during laparoscopic cholecystectomy are randomized in a 1:1:1 ratio into three parallel intervention arms: vertical fascial extension, horizontal fascial extension, and tri-radial fascial micro-incision technique/Tareq's Port Extension. Outcomes are compared among the three groups.
| Arm | Type | Receives |
|---|---|---|
| Vertical Fascial Extension | Active comparator | Procedure: Vertical Fascial ExtensionParticipants assigned to this arm undergo conventional vertical extension of the umbilical fascial opening when gallbladder extraction is difficult during laparoscopic cholecystectomy. The fascial opening is extended vertically in the midline as required to facilitate specimen extraction. |
| Horizontal Fascial Extension | Active comparator | Procedure: Horizontal Fascial ExtensionParticipants assigned to this arm undergo conventional horizontal extension of the umbilical fascial opening when gallbladder extraction is difficult during laparoscopic cholecystectomy. The fascial opening is extended transversely as required to facilitate specimen extraction. |
| Tri-Radial Fascial Micro-Incision | Experimental | Procedure: Tri-Radial Fascial Micro-IncisionParticipants assigned to this arm undergo the tri-radial fascial micro-incision technique, also designated Tareq's Port Extension. Three small radial fascial micro-incisions are made around the umbilical fascial opening to create controlled expansion and facilitate difficult gallbladder extraction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients aged 18 to 70 years.
- Patients undergoing laparoscopic cholecystectomy for benign gallbladder disease.
- Intraoperatively confirmed difficult gallbladder extraction through the umbilical port site.
- Difficult extraction due to large gallbladder size, thickened gallbladder wall, large stone, multiple packed stones, or resistance at the fascial level.
- Patients willing to participate and provide written informed consent.
Key exclusion criteria (8 listed)
- Conversion to open cholecystectomy before gallbladder extraction.
- Suspected or confirmed gallbladder malignancy.
- Uncorrected coagulopathy.
- Pregnancy.
- Previous major midline abdominal surgery affecting the umbilical port site.
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 |
|---|---|---|
| Vertical Fascial ExtensionConventional vertical extension of the umbilical fascial opening during difficult gallbladder extraction in laparoscopic cholecystectomy. The fascial defect is extended vertically in the midline as required to allow extraction of a large or stone-filled gallbladder specimen. | Procedure or surgery | Vertical Fascial Extension |
| Horizontal Fascial ExtensionConventional horizontal extension of the umbilical fascial opening during difficult gallbladder extraction in laparoscopic cholecystectomy. The fascial defect is extended transversely as required to facilitate removal of a large or stone-filled gallbladder specimen. | Procedure or surgery | Horizontal Fascial Extension |
| Tri-Radial Fascial Micro-IncisionTri-radial fascial micro-incision technique used during difficult gallbladder extraction in laparoscopic cholecystectomy. Three small radial fascial micro-incisions are made around the umbilical fascial opening, approximately at the 12, 4, and 8 o'clock positions, to create controlled expansion and facilitate specimen extraction. | Procedure or surgery | Tri-Radial Fascial Micro-Incision |
Primary outcome
Extraction-Site Bleeding Severity
Time frame: Intraoperative, during gallbladder specimen extraction
Severity of bleeding from the umbilical fascial extraction site during difficult gallbladder extraction. Bleeding will be categorized as minimal, moderate, or profuse. Minimal bleeding is defined as no active bleeding or minor oozing controlled with simple pressure or brief cautery. Moderate bleeding is defined as bleeding requiring additional hemostatic intervention but not causing major operative interruption. Profuse bleeding is defined as brisk bleeding requiring prolonged hemostatic effort, suturing, or significant interruption of specimen extraction.
Specimen Extraction Time
Time frame: Intraoperative, during gallbladder specimen extraction
Time required to extract the gallbladder specimen after confirmation of difficult extraction and initiation of fascial extension technique. Time will be measured in minutes from the start of fascial extension to complete removal of the gallbladder specimen through the umbilical port site.
6 secondary outcomes
Fascial Extension Length
Time frame: Intraoperative, immediately after specimen extraction
Postoperative Pain Score
Time frame: 24 hours after surgery
Analgesic Requirement
Time frame: Within 24 hours after surgery
Port-Site Wound Complications
Time frame: Up to 30 days after surgery
Cystic Duct Clip Dislodgement
Time frame: Intraoperative, during gallbladder specimen extraction
Port-Site Hernia
Time frame: 12 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Background: PubMed 20332511Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
- Background: PubMed 21686296Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. Open Med. 2010;4(1):e60-8. Epub 2010 Mar 24. No abstract available.
- Background: PubMed 21672662Owens M, Barry M, Janjua AZ, Winter DC. A systematic review of laparoscopic port site hernias in gastrointestinal surgery. Surgeon. 2011 Aug;9(4):218-24. doi: 10.1016/j.surge.2011.01.003. Epub 2011 Feb 1.
- Background: PubMed 22213083Swank HA, Mulder IM, la Chapelle CF, Reitsma JB, Lange JF, Bemelman WA. Systematic review of trocar-site hernia. Br J Surg. 2012 Mar;99(3):315-23. doi: 10.1002/bjs.7836. Epub 2011 Dec 30.
- Background: PubMed 27177957Comajuncosas J, Hermoso J, Jimeno J, Gris P, Orbeal R, Cruz A, Pares D. Effect of bag extraction to prevent wound infection on umbilical port site wound on elective laparoscopic cholecystectomy: a prospective randomised clinical trial. Surg Endosc. 2017 Jan;31(1):249-254. doi: 10.1007/s00464-016-4965-z. Epub 2016 May 13.
- Background: PubMed 30453917La Regina D, Mongelli F, Cafarotti S, Saporito A, Ceppi M, Di Giuseppe M, Ferrario di Tor Vajana A. Use of retrieval bag in the prevention of wound infection in elective laparoscopic cholecystectomy: is it evidence-based? A meta-analysis. BMC Surg. 2018 Nov 19;18(1):102. doi: 10.1186/s12893-018-0442-z.
- Background: PubMed 27643488Majid MH, Meshkat B, Kohar H, El Masry S. Specimen retrieval during elective laparoscopic cholecystectomy: is it safe not to use a retrieval bag? BMC Surg. 2016 Sep 19;16(1):64. doi: 10.1186/s12893-016-0181-y.
- Background: PubMed 1826143Southern Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies. N Engl J Med. 1991 Apr 18;324(16):1073-8. doi: 10.1056/NEJM199104183241601.
- Background: PubMed 8000648Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results may be shared upon reasonable request after publication of the main study results. Data will include demographic variables, operative findings, allocated intervention, primary outcome measures, secondary outcome measures, and follow-up data relevant to port-site complications and hernia. No directly identifiable patient information will be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertical Fascial Extension, Horizontal Fascial Extension and Tri-Radial Fascial Micro-Incision in people with Cholelithiasis and Difficult Gallbladder Extraction, run by Bangladesh Navy at 1 site in Bangladesh.
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 6 inclusion and 8 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 19 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 Bangladesh. 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?
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?
Extraction-Site Bleeding Severity (time frame: Intraoperative, during gallbladder specimen extraction). The study lists 2 primary outcomes in all. 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 NCT07595692, which also lists 10 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 19 May 2026.