Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206919034739 Date of Approval: 29/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Short-term Outcomes of Reduced versus Conventional Ports in Sleeve Gastrectomy: A Controlled Clinical Trial
Official scientific title Short-term Outcomes of Reduced versus Conventional Ports in Sleeve Gastrectomy: A Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Bariatric surgery for morbid obesity is associated with significant weight loss and decreased mortality, and laparoscopic sleeve gastrectomy is the most frequently performed surgical procedure worldwide. With the accumulation of experience and the advancement of equipment for FP-LDG, the number of incisions for ports has been reduced, resulting in improved postoperative quality of life in terms of scarring. Single-incision laparoscopic surgery (SILS) was first introduced in the 1990s, and its application has been extended to various surgical procedures. SILS has been associated with less postoperative pain, lower risk of wound infection, shorter hospital stay, and better cosmoses. Single-port sleeve gastrectomy (SPSG) and reduced port sleeve gastrectomy (RPSG) that utilizes one additional port have been increasingly reported in the literature. However, there is still an ongoing debate on whether the technical difficulties of the single-port approach might lead to an increased risk of postoperative morbidity and suboptimal sleeve construction. The technique described in our study involves the introduction of three ports. First a vertical 1–1.2-cm skin incision is made starting slightly off and above the apex of the umbilicus. Two 5-mm ports are inserted laterally and superior to the 12-mm port, to create a triangle with approximately 5-10-cm sides. The left lobe of the liver is retracted internally by 2.0 polypropylene stitch (30 cm) on a straight cutting needle (Keith) which is passed through the mid-upper abdomen 5–7 cm below the xiphoid process and fixed into the Right crus of Diaphragm. In the present study, we are comparing the short-term outcomes of reduced ports sleeve gastrectomy versus conventional 5 ports sleeve gastrectomy in postoperative weight loss, morbidity rate, pain, and resolution of obesity-related diseases.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Morbid Obesity,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2022
Actual trial start date
Anticipated date of last follow up 15/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 130
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Reduced ports group NA Once A transverse 1–1.2-cm skin incision is made starting slightly off and above the apex of the umbilicus. A Veress needle is then inserted to establish a pneumoperitoneum of 12–15 mmHg. A 12-mm Optiview trocar is then inserted. Next, two 5-mm ports are inserted laterally and superior to the 12-mm port, to create a triangle with approximately 5-10-cm sides. 65
Control Group Conventional ports group NA Once one 10-mm port is inserted just above the umbilicus for the endoscope. Two 12-mm ports are inserted at the right and left mid-clavicular lines for the operator’s both hands. One 5 mm incision is made below the xiphoid process for introducing the liver retractor. One 5-mm port inserted at the left side of the abdomen the assistant. 65 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- BMI from 40 to 50 - BMI 35 – 40 with obesity related comorbidities (e.g. hypertension, hyperlipidemia, type 2 diabetes mellitus, obstructive sleep apnea, obesity hypoventilation syndrome, non-alcoholic fatty liver disease, gastroesophageal reflux disease and severe arthritis). - Able to give informed consent. - Able to be committed to follow-up. - Previous upper GIT surgery or liver cirrhosis. - Oral steroid therapy. - Previous bariatric surgery. - Not fit for general anaesthesia (e.g. patients with severe heart disease or untreatable coagulopathies). - Patient with contraindications for insufflation as those with sever cardiovascular or sever restrictive respiratory diseases. - Significant abdominal ventral hernia. - Major psychiatric illness. - Pregnancy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/06/2022 Research Ethics Committee REC Faculty of Medicine Ain Shams University FWA 0006379
Ethics Committee Address
Street address City Postal code Country
56 ramsis street Abbasya Cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Operative time Time of the whole operation
Primary Outcome Postoperative Pain measured by numeric rating score (NRS) 2, 6, 12, 24 hours postoperatively
Secondary Outcome Excess body weight loss 2 weeks, 2 months, 3 months postoperatively
Secondary Outcome Hospital stay Postoperative hospital stay in days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Surgery department Ain Shams University Ramsis Street Cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Karim sabry Abd el samee Atia 13 saada st Maadi Cairo 11728 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Surgery Ain shams university Ramsis Street Cairo 11517 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Karim sabry Abd el samee Atia 13 saada st, Maadi Cairo 11728 Egypt
Medhat M. Helmy Khalil 6 mahmoud abu eloyoon street, Elnozha Cairo 11843 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karim Atia Karim_sabry@med.asu.edu.eg 00201033335498 13 saada st,Maadi
City Postal code Country Position/Affiliation
Cairo 11728 Egypt Assistant Professor of Surgery Ain Shams University Cairo Egypt
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Medhat Khalil medhat.abdelhalim@med.asu.edu.eg 00201001653647 6 mahmoud abu eloyoon street, Elnozha
City Postal code Country Position/Affiliation
Cairo 11843 Egypt Assistant Professor of Surgery Ain Shams University Cairo Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send an e-mail to elsayedamr@yahoo.com (public relations) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information