Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain

NCT ID: NCT04346550

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2018-10-17

Brief Summary

The purpose of this study was to compare the frequency of pain and mean hospital stay in patients with and without drain insertion, following laparoscopic cholecystectomy for acutely inflamed gallbladder.

Detailed Description

Most hospitals in Pakistan still do not have a policy of early laparoscopic cholecystectomy in acutely inflamed gallbladder, partly because of feared higher conversion rates to open procedure and presumed increased risk of complications. There are fewer local studies to elaborate the role of drain after laparoscopic cholecystectomy for acutely inflamed gallbladder. This study was conducted to analyze the role of routine use of drains after laparoscopic cholecystectomy for acutely inflamed gallbladder. Does it offer any advantage in detecting bile leak or bleeding. Also to prove that placing drains prolongs the hospital stay and increases postoperative pain in comparison to patients in whom drain is not placed.

After being informed about the study and the potential risks, all patients giving written informed consent, underwent laparoscopic cholecystectomy using conventional 4 port method. Patients were divided in two groups by lottery method. Group A - no drain group and Group B - drain group. Post operatively parameters of pain and total hospital stay were assessed and analysed.

Conditions

Acute Cholecystitis; Pain; Morbidity, Multiple; Surgery; Drain Site Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Drain Group

Suction drain was placed in sub hepatic region through 5 mm lateral trocar site.

Group Type: ACTIVE_COMPARATOR

Suction drain

Intervention Type: OTHER

Post operatively, in both arms including drain group and no drain group, parameters of pain was assessed by visual analog scale (VAS) from 0 (no pain) to 10 (worst pain), assessed at 1st postoperative day by the duty doctor or the nurse. VAS \> 3 was considered as post surgical pain. The total number of hospital stay was noted from the day of operation till the day of discharge and discharge criteria was taken as a patient having pain as per VAS\<3, no fever and tolerating oral intake

Without Drain Group

No drain was placed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Suction drain

Post operatively, in both arms including drain group and no drain group, parameters of pain was assessed by visual analog scale (VAS) from 0 (no pain) to 10 (worst pain), assessed at 1st postoperative day by the duty doctor or the nurse. VAS \> 3 was considered as post surgical pain. The total number of hospital stay was noted from the day of operation till the day of discharge and discharge criteria was taken as a patient having pain as per VAS\<3, no fever and tolerating oral intake

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All the patients of either sex with ages between 20 - 80 years, diagnosed with acutely inflamed gallbladder, undergoing laparoscopic cholecystectomy were included in the study

Exclusion Criteria

• All patients having concurrent operations on other organs, or with history of previous upper abdominal surgery, or with immunodeficiency states because of liver or renal transplantation or already diagnosed with HIV infection, or surgeries requiring open conversions, or surgeries in which there was hollow visceral organ injury, or patient requiring common bile duct (CBD) exploration or patients having any bleeding disorder, or surgeries where there is doubt of cystic duct stump or CBD injury, were excluded from the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shifa International Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Hira Saleem

Post Graduate Resident, Principal Investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hira Saleem, FCPS Surgery

Role: PRINCIPAL_INVESTIGATOR

Shifa International Hospital

Locations

Shifa International Hospital

Islamabad, Federal Capital, Pakistan

Countries

Pakistan

Other Identifiers

Sheikh

Identifier Type: -

Identifier Source: org_study_id