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

NCT ID: NCT04836598

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-04-30

Brief Summary

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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

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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,

Conditions

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Cholecystitis, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multiport laparoscopic cholecystectomy

controlled group

Group Type ACTIVE_COMPARATOR

laparoscopic cholecystectomy

Intervention Type OTHER

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).

Bikini line laparoscopic cholecystectomy

bikini line 2 ports

Group Type ACTIVE_COMPARATOR

laparoscopic cholecystectomy

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Other Intervention Names

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brief port scarless laparoscopic cholecystectomy

Eligibility Criteria

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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,
Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bassem Mohamed Sieda

assistant professor of general surgeryt

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bassem M Sieda, professor

Role: STUDY_CHAIR

1975

Locations

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Zagazig University hospitals

Zagazig, Outside USA, Egypt

Site Status RECRUITING

Zagazig University hospitals

Zagazig, Outside USA, Egypt

Site Status COMPLETED

Saudi German hospital

Riyadh, Outside USA, Saudi Arabia

Site Status RECRUITING

Saudi german hospital

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Egypt Saudi Arabia

Central Contacts

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Bassem M Sieda, professor

Role: CONTACT

0541900039

Bassem M Sieda, professor

Role: CONTACT

Facility Contacts

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Bassem M Sieda, professor

Role: primary

Bassem M Sieda

Role: backup

Bassem M Sieda

Role: primary

0541900039

Bassem M Sieda

Role: primary

00966541900039 ext. 00966541900039

Other Identifiers

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11671

Identifier Type: -

Identifier Source: org_study_id

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