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

Cholecystitis, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04836598
• Other study ID #: 11671
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2016
• Est. completion date: April 30, 2021

Study information

• Verified date: April 2021
• Source: Zagazig University
• Contact: Bassem M Sieda, professor
• Phone: 0541900039
• Email: drbassemmostafa[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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,

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: April 30, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 65 Years

Eligibility

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,

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Chronic
• Obesity, Morbid

Intervention

Other:
• laparoscopic cholecystectomy
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).

Locations

Country	Name	City	State
Egypt	Zagazig University hospitals	Zagazig	Outside USA
Egypt	Zagazig University hospitals	Zagazig	Outside USA
Saudi Arabia	Saudi German hospital	Riyadh	Outside USA
Saudi Arabia	Saudi german hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 years
Secondary	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	3 years