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Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.

Primary Purpose

Cholecystitis, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
laparoscopic cholecystectomy
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis, Chronic focused on measuring scarless cholecystectomy, Breif port cholecystectomy

Eligibility Criteria

17 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3.

Exclusion Criteria:

  • Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day.

Patients required additional trocars for patient safety, readmission,

Sites / Locations

  • Zagazig University hospitalsRecruiting
  • Zagazig University hospitals
  • Saudi German hospitalRecruiting
  • Saudi german hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Multiport laparoscopic cholecystectomy

Bikini line laparoscopic cholecystectomy

Arm Description

controlled group

bikini line 2 ports

Outcomes

Primary Outcome Measures

a successful and safe day case
a successful and safe day case laparoscopic cholecystectomy with discharge on the same day with no significant pain. patient stayed more than a day was not enrolled

Secondary Outcome Measures

Measured patient satisfaction from body image and cosmoses within 6 months from surgery.
Postoperative pain was defined as mild, moderate sever according to visual analogue scale (VAS) Pain assessment at the tommy and at port sites were assessed at postoperative day 1 and at discharge as follow, 8 hours, at discharge time at 12 hours or 24 hours postoperative, and after discharge at 48 hours, 72 hours achieved through Telephone call with the patient. Patient satisfaction from cosmetic outcome was measured on 10 points scale. Divided into mild satisfied (1-3 points), moderate (4-7)and highly satisfied (8-10 points) at the second postoperative visit at 30 days postoperative, after 3 months and after 6 months, based on patient question to rate it, mild satisfaction: 1-3, moderate satisfaction:4-7 and highly satisfied: from 8-10

Full Information

First Posted
March 31, 2021
Last Updated
April 5, 2021
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT04836598
Brief Title
Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
Official Title
Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 30, 2016 (Actual)
Primary Completion Date
April 20, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Bikini line laparoscopic cholecystectomy is a safe method, used as a scarless cosmetic port technique for gall bladder diseases in morbid obese patients as a day case. Objectives: The aim of this study was to investigate the safety and efficacy of an elective Bikini line laparoscopic cholecystectomy in the morbid obese patients with chronic calcular cholecystitis, and review our experience with Bikini line laparoscopic cholecystectomy as minimal invasive scarless technique. We issued a modifications in order to minimize the number of ports (Brief ports) and modify port sites, using the Bikini line laparoscopic cholecystectomy as a cosmetic and hidden scar laparoscopy for obese patients concerned with aesthetic results and body image. Aiming at faster recovery, decrease pain and improve cosmoses. Bikini Line laparoscopic cholecystectomy is technically safe and effective day surgery procedure for chronic cholecystitis patients with higher patient satisfaction regarding pain and cosmoses. Obesity, intended as BMI 40, does not have any obstacle on the technical feasibility of BLLC.
Detailed Description
Thoroughly, BLLC is a novel technique aimed at solving the issue of cosmoses that is always presented as a main complaint from morbid obese patients. The main concern to use Brief ports laparoscopy or hidden scar laparoscopy to reduce incisions and change sites. The study designed to identify superiority of technique regarding success as a day case surgery, better cosmoses and lesser pain. We tried to wear off the port sites scar and kept our stabs in the suprapubic Bikin line. We kept camera port in the navel's natural scar and used the other ports in lower abdominal crease at Bikini line. Cosmosis has been and still the reason among patient population to accept the laparoscopic surgery, many synonyms can be applied here, as Cosmotic,Hidden scar, Scarless, Non-visualized or Scarless Bikini cholecystectomy. BLLC is performed under general anesthesia. Patient placed in the supine position with patient's legs apart and arms are rolled in, patient strapped to table at the mid-thigh. Surgeon stood between patient's legs, the camera man stood on the right side of patient, monitor placed near patient head to the right side. Three ports were used, 12 mm visiport (….) umbilical, with A 30 degree camera used, 5mm in Bikini line at Right mid-clavicular line and third port 5mm in Bikini line at left mid-clavicular line (Figure) Patient kept in reverse Trendlenburg position with maximum degree 20. But to lesser degree than done in classic LC,

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Chronic
Keywords
scarless cholecystectomy, Breif port cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly allocated into 2 groups (Consort Chart) and each group categorized into 3 subgroups according to BMI, into class I: Obese Class 1 30-34.9kg/m2, Class II: Obese Class II 35-39.9kg/m2 and class III: Morbidly Obese Class III >40kg/m2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multiport laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
controlled group
Arm Title
Bikini line laparoscopic cholecystectomy
Arm Type
Active Comparator
Arm Description
bikini line 2 ports
Intervention Type
Other
Intervention Name(s)
laparoscopic cholecystectomy
Other Intervention Name(s)
brief port scarless laparoscopic cholecystectomy
Intervention Description
A Prospective randomized controlled trial study was undertaken along 4 years Between November 2016 and October 2020, in two institutions. 400 patients were selected, 200 patients underwent BLLC and 200 patients underwent multiple port laparoscopic cholecystectomy (MPLC).
Primary Outcome Measure Information:
Title
a successful and safe day case
Description
a successful and safe day case laparoscopic cholecystectomy with discharge on the same day with no significant pain. patient stayed more than a day was not enrolled
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Measured patient satisfaction from body image and cosmoses within 6 months from surgery.
Description
Postoperative pain was defined as mild, moderate sever according to visual analogue scale (VAS) Pain assessment at the tommy and at port sites were assessed at postoperative day 1 and at discharge as follow, 8 hours, at discharge time at 12 hours or 24 hours postoperative, and after discharge at 48 hours, 72 hours achieved through Telephone call with the patient. Patient satisfaction from cosmetic outcome was measured on 10 points scale. Divided into mild satisfied (1-3 points), moderate (4-7)and highly satisfied (8-10 points) at the second postoperative visit at 30 days postoperative, after 3 months and after 6 months, based on patient question to rate it, mild satisfaction: 1-3, moderate satisfaction:4-7 and highly satisfied: from 8-10
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3. Exclusion Criteria: Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day. Patients required additional trocars for patient safety, readmission,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassem M Sieda, professor
Phone
0541900039
Email
drbassemmostafa@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bassem M Sieda, professor
Email
drbassemmostafa@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassem M Sieda, professor
Organizational Affiliation
1975
Official's Role
Study Chair
Facility Information:
Facility Name
Zagazig University hospitals
City
Zagazig
State/Province
Outside USA
ZIP/Postal Code
12345
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem M Sieda, professor
Email
drbassemmostafa@yahoo.com
First Name & Middle Initial & Last Name & Degree
Bassem M Sieda
Email
drbassemmostafa@yahoo.com
Facility Name
Zagazig University hospitals
City
Zagazig
State/Province
Outside USA
ZIP/Postal Code
12345
Country
Egypt
Individual Site Status
Completed
Facility Name
Saudi German hospital
City
Riyadh
State/Province
Outside USA
ZIP/Postal Code
11671
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem M Sieda
Phone
0541900039
Email
drbassemmostafa@yahoo.com
Facility Name
Saudi german hospital
City
Riyadh
ZIP/Postal Code
11671
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bassem M Sieda
Phone
00966541900039
Ext
00966541900039
Email
drbassemmostafa@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data can be shared through the publisher and all authers
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
publisher which is international journa

Learn more about this trial

Bikini Scarless Laparoscopic Cholecystectomy for Morbid Obesity as a Day Case.

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