Cholecystectomy, LaparoscopicNCT07823803
Improvised Endobag vs Direct Gallbladder Extraction in Laparoscopic Cholecystectomy
A study testing Endobag in people with Cholecystectomy, Laparoscopic and Cholelithiasis, run by Rawal Institute of Health Sciences Islamabad at 1 site in Pakistan.
Trial summary
Eligigble patients will be enrolled after obtaining informed consent. Basic information such as age, gender, body weight, smoking and alcohol history, number of gallstones, and gallbladder characteristics will be recorded. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Cholelithiasis
- What is being tested?
- Endobag
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Aug 2026to 30 Nov 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective Laparoscopic Cholecystectomy
Who cannot join
- Patients having common bile duct stones or dilatation
- Acute cholecystitis, gallbladder perforation, malignancy (on medical record).
- Patients requiring conversion to open cholecystectomy, ASA III-IV
- Patients with skin diseases near wound site, diabetes (HbA1c>6.5%), and Hb <10gm/dl
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
Rawal Institute of Health Sciences
Islamabad, Federal, 44000
Mirza
Mirza Inam Ul Haq, MBBS,MPH,MBA,PhD,PGD-HPE,MHPE, +92-300-9527527, fihs06.2023@gmail.com
About this study
Official title: Retrieval of Gallbladder by Improvised Endobag Versus Direct Extraction in Laparoscopic Cholecystectomy
Eligigble patients will be enrolled after obtaining informed consent. Basic information such as age, gender, body weight, smoking and alcohol history, number of gallstones, and gallbladder characteristics will be recorded.
During surgery, the method used to remove the gallbladder, the port used for extraction, and the duration of surgery will be documented. Any gallbladder perforation, leakage of bile, or spillage of gallstones during the procedure will also be recorded.
Read more
After surgery, patients will be monitored in the hospital for 24 hours. Their pain will be assessed before discharge. Patients will then be followed in the outpatient clinic for 10 days to assess wound healing and identify any wound infection or other complications.
The study aims to compare the safety and effectiveness of an improvised retrieval bag with removal of the gallbladder without a retrieval bag during laparoscopic surgery.
Read the detailed description
Eligible patients undergoing laparoscopic cholecystectomy will be enrolled after obtaining written informed consent. Baseline demographic and clinical characteristics, including age, gender, body mass index, smoking and alcohol history, hypertension, number of gallstones, and gallbladder wall thickness, will be recorded.
Patients will be randomly allocated to receive one of the predefined gallbladder extraction techniques. The port site used for gallbladder retrieval and total operative time will be documented. Intraoperative events, including gallbladder perforation, bile spillage, and stone spillage, will be recorded according to predefined operational definitions.
All procedures will be performed under general anesthesia by the same surgical team. Wound closure will be performed by the researcher using a standardized technique to minimize procedural variability and potential bias.
Following surgery, patients will be monitored in the postoperative ward for 24 hours. Postoperative pain will be assessed using a standardized pain score before discharge. Patients will subsequently be followed in the outpatient department for 10 days, during which the surgical wound will be assessed for infection and other relevant postoperative complications.
- Conditions
- Cholecystectomy, Laparoscopic, Cholelithiasis
- Being tested
- Endobag, placebo group
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndobagDevice
Gallbladder will be removed using Endobag
placebo groupDevice
Gallbladder will be removed without using Endobag during Laparoscopic Cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Group Endobag | Active comparator | Not described Receives: Device: Endobag |
| Group Control | Placebo comparator | Not described Receives: Device: placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Time
Measured: This will be the time in minutes measured Peri-procedurally from skin incision to skin closure
Visible perforation of the gallbladder developed during gallbladder removal
Measured: Perioperative/Periprocedural
Visible spillage of bile from the gallbladder during gallbladder removal
Measured: Perioperative/Periprocedural (at the time of gallbladder removal)
Visible spillage of gallstones from the gallbladder during gallbladder removal
Measured: Perioperative/Periprocedural
Port site pain
Measured: It will be assessed using Visual Analog scale at 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start30 Aug 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawal Institute of Health Sciences Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadia Ali, Rawal Institute of Health Sciences Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823803
- Sponsor's protocol ID
- RIHS/IRB/63/2025
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical committee doesnt allow data sharing
Publications
Elangovan S, Naathan KVS, Sivamarieswaran R, Jose MR. Direct Gallbladder Extraction versus Endobag Extraction during Laparoscopic Cholecystectomy: A Prospective Observational Study. J Clin Diagn Res. 2025;19(8):PC12-PC5.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrieval of Gallbladder by Improvised Endobag Versus Direct Extraction in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07823803
- Acronym / sponsor ID
- RIHS/IRB/63/2025
- Conditions
- Cholecystectomy, Laparoscopic, Cholelithiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rawal Institute of Health Sciences IslamabadUniversity, hospital or other
- Study start
- 30 Aug 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Sep 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.
Eligigble patients will be enrolled after obtaining informed consent. Basic information such as age, gender, body weight, smoking and alcohol history, number of gallstones, and gallbladder characteristics will be recorded.
During surgery, the method used to remove the gallbladder, the port used for extraction, and the duration of surgery will be documented. Any gallbladder perforation, leakage of bile, or spillage of gallstones during the procedure will also be recorded.
After surgery, patients will be monitored in the hospital for 24 hours. Their pain will be assessed before discharge. Patients will then be followed in the outpatient clinic for 10 days to assess wound healing and identify any wound infection or other complications.
The study aims to compare the safety and effectiveness of an improvised retrieval bag with removal of the gallbladder without a retrieval bag during laparoscopic surgery.
Detailed description
Eligible patients undergoing laparoscopic cholecystectomy will be enrolled after obtaining written informed consent. Baseline demographic and clinical characteristics, including age, gender, body mass index, smoking and alcohol history, hypertension, number of gallstones, and gallbladder wall thickness, will be recorded.
Patients will be randomly allocated to receive one of the predefined gallbladder extraction techniques. The port site used for gallbladder retrieval and total operative time will be documented. Intraoperative events, including gallbladder perforation, bile spillage, and stone spillage, will be recorded according to predefined operational definitions.
All procedures will be performed under general anesthesia by the same surgical team. Wound closure will be performed by the researcher using a standardized technique to minimize procedural variability and potential bias.
Following surgery, patients will be monitored in the postoperative ward for 24 hours. Postoperative pain will be assessed using a standardized pain score before discharge. Patients will subsequently be followed in the outpatient department for 10 days, during which the surgical wound will be assessed for infection and other relevant postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Endobag | Active comparator | Device: Endobag |
| Group Control | Placebo comparator | Device: placebo group |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective Laparoscopic Cholecystectomy
Key exclusion criteria (4 listed)
- Patients having common bile duct stones or dilatation
- Acute cholecystitis, gallbladder perforation, malignancy (on medical record).
- Patients requiring conversion to open cholecystectomy, ASA III-IV
- Patients with skin diseases near wound site, diabetes (HbA1c>6.5%), and Hb <10gm/dl
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 |
|---|---|---|
| EndobagGallbladder will be removed using Endobag | Device | Group Endobag |
| placebo groupGallbladder will be removed without using Endobag during Laparoscopic Cholecystectomy | Device | Group Control |
Primary outcome
Surgical Time
Time frame: This will be the time in minutes measured Peri-procedurally from skin incision to skin closure
Visible perforation of the gallbladder developed during gallbladder removal
Time frame: Perioperative/Periprocedural
Visible spillage of bile from the gallbladder during gallbladder removal
Time frame: Perioperative/Periprocedural (at the time of gallbladder removal)
Visible spillage of gallstones from the gallbladder during gallbladder removal
Time frame: Perioperative/Periprocedural
Port site pain
Time frame: It will be assessed using Visual Analog scale at 24 hours post procedure
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 16 Sep 2026.
- BackgroundElangovan S, Naathan KVS, Sivamarieswaran R, Jose MR. Direct Gallbladder Extraction versus Endobag Extraction during Laparoscopic Cholecystectomy: A Prospective Observational Study. J Clin Diagn Res. 2025;19(8):PC12-PC5.
- Individual participant dataSharing planned: No. Ethical committee doesnt allow data sharing
Related trials for Cholecystectomy, Laparoscopic
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
Active, not recruiting
Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
Acut Postoperative Pain, Erector Spinae Plane Block
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
RecruitingPhase 4
Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy
Intravenous Anesthesia, Cholelithiasis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endobag in people with Cholecystectomy, Laparoscopic and Cholelithiasis, run by Rawal Institute of Health Sciences Islamabad 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 1 inclusion and 4 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 16 Sep 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?
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 Sadia Principal Investigator, MBBS (+92-318-5190442, sadiaali603@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Time (time frame: This will be the time in minutes measured Peri-procedurally from skin incision to skin closure). The study lists 5 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 NCT07823803, which also lists 1 linked publication.
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 16 Sep 2026.