Health TrialsbyHealthPanel

Improvised Endobag vs Direct Gallbladder Extraction in Laparoscopic Cholecystectomy

ConditionsCholecystectomy, LaparoscopicCholelithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorRawal Institute of Health Sciences Islamabad

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Elective Laparoscopic Cholecystectomy

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Endobag

    Device

    Gallbladder will be removed using Endobag

  • placebo group

    Device

    Gallbladder will be removed without using Endobag during Laparoscopic Cholecystectomy

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group EndobagActive comparator 1 intervention
Group B: Group ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Surgical Time

Time frame
This will be the time in minutes measured Peri-procedurally from skin incision to skin closure
2

Visible perforation of the gallbladder developed during gallbladder removal

Time frame
Perioperative/Periprocedural
3

Visible spillage of bile from the gallbladder during gallbladder removal

Time frame
Perioperative/Periprocedural (at the time of gallbladder removal)
4

Visible spillage of gallstones from the gallbladder during gallbladder removal

Time frame
Perioperative/Periprocedural

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rawal Institute of Health Sciences Islamabad

Lead sponsor

Source ClinicalTrials.gov
Apply now