A study to compare the complications like pain, hernia and operation site infection after surgery between the umbilicus and below the chest bone keyhole in patients undergoing keyhole cholecystectomy

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2024/02/062432

Lead Sponsor: christian medical college

Brief Summary: Since the advent of minimal invasive surgery, laparoscopic cholecystectomy has taken a storm and becomes a preferred procedure for all benign gall bladder condition. Though it has become the standard procedure, there is still a debate between which port to be used for gall bladder retrieval during four port laparoscopic cholecystectomy. Our study aims to compare the postoperative site pain, surgical site occurrence, difficulty in retrieval of GB and port site hernia after gall bladder (GB) retrieval through the umbilical vs epigastric port site.

This will be a randomized control trial in which total number of patients who are planned for elective cholecystectomy by surgery unit 4 will be chosen and they would be randomized in to two groups: (A) the umbilical port group (GB retrieval through the umbilical port) and (B) the epigastric port group (GB retrieval through the epigastric port). Both the groups will be prepared similarly in their preoperative period. Laparoscopic cholecystectomy (LC) shall be done by the experienced surgeon. The GB specimen will be removed via umbilical or epigastric port depending upon the allocation of groups using a retrieval bag. Their pain at the respective port site to be assessed by visual analog scale (VAS) at 6, 12, 24 and 36 hours postoperatively as mentioned in the methodology. Wound to be inspected for surgical site occurrence on the day of discharge and 1st follow up visit after discharge. Following that patient shall be followed up telephonically on day 30 to enquire about the status of the surgical site. Postoperative analgesic of choice will be similar between both the groups mainly bupivacaine locally at the port site following that Injection paracetamol and Tramadol/Diclofenac depending on the renal status of the patient on Day 1 and to be changed to oral tablets on subsequent postoperative days. Then difficulty in retrieval of GB between ports would be assessed by time taken for removal, rupture of the Endo bag, single large stone and presence of multiple stone. Presence of port site hernia at the respective port to be assessed in 6 months, follow up post-surgery. Then all the data will be collected, analyzed to compare the postoperative site pain and surgical site infection after GB retrieval through the umbilical vs epigastric port site in patients undergoing four port elective LC.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

I.Persons of age between 18-75years who are undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis, gall bladder polyp in surgery unit IV of CMC II.Persons of age between 18-75years who are undergoing interval Laparoscopic cholecystectomy for acute cholecystitis in surgery unit IV of CMC.

Exclusion Criteria

I.Acute cholecystitis, empyema GB, mucocele of GB II.Suspected/proven malignancy of GB III.Patients undergoing other surgical interventional (eg.
Hernia repair) procedures along with laparoscopic cholecystectomy for benign GB disease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess postoperative pain using Visual Analog scale	Postoperative pain assessment using Visual Analog Scale at 6 12 24 36 hours

Secondary Outcome Measures

Name	Time	Method
Port site occurrence like seroma, hematoma & infection	Difficulty in GB retrieval by means of time taken for retrieval, GB/Endo bag perforation & multiple stones or single large stone that made retrieval difficult.

Trial Locations

Locations (1): Christian medical college Hospital
🇮🇳
Vellore, TAMIL NADU, India
Christian medical college Hospital
🇮🇳Vellore, TAMIL NADU, India
Dr Ramesh Tony
Principal investigator
9080767672
srameshtony@gmail.com