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.: PACTR202311528755058 Date of Approval: 09/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clinical and Hemodynamic Outcomes of Surgical Repair of Tricuspid Valve Regurgitation in Adults: A Randomized Clinical Study
Official scientific title Clinical and Hemodynamic Outcomes of Surgical Repair of Tricuspid Valve Regurgitation in Adults: A Randomized Clinical Study
Brief summary describing the background and objectives of the trial In recent years, annuloplasty has become an established surgical approach to significant TR. The management of functional TR and choice of most appropriate surgical techniques remain debated among various surgical teams. An ideal tricuspid annuloplasty should take into consideration the anatomic and functional characteristics of the normal and pathologic TV. It should be cost-effective, easy to perform, and safe, preserving the normal function of the TV and free of complications such as thromboembolism or heart block, durable, and free of long-term of recurrence of TR. The aim of the presented work is to evaluate the feasibility and short-term outcomes of the De-Vega semicircular sutured annuloplasty versus segmental sutured annuloplasty versus other valvuloplasty techniques in the repair of tricuspid valve regurgitation in adults.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/09/2017
Actual trial start date 03/09/2017
Anticipated date of last follow up 08/08/2023
Actual Last follow-up date 01/10/2023
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Completed
Publication URL
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 Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tricuspid Valve annuloplasty Devega repair 25 patients All cases undergoing mitral valve intervention requiring concomitant Devega tricuspid repair will be included and follow up for up to 3 years post operative In course of mitral valve replacement, Patients were randomized using computer into three groups: Group A: Patients who underwent De-Vega Annuloplasty (n=25). Using right atriotomy, a classic DeVega procedure (single pledgeted 2/0 Ethibond sutures from the posteroseptal to the anteroseptal commissure with a pledget at each end). Two sequential sutures will be placed in this fashion in a clockwise direction through the annulus and tightened. All methods of repair were followed by saline test intraoperatively and the repair technique is considered successful if equal to or less than mild regurgitation was encountered. No failure was encountered intraoperatively for any method of tricuspid repair. In the 3 groups A size 31 or 33mm Carpentier Edwards’s sizer was fitted into the right ventricle cavity through the tricuspid valve orifice before tying prevent over correction leading to iatrogenic tricuspid stenosis. 25
Experimental Group Tricuspid segmental Annuloplasty 25 patients follow for up to 3 years patients in this group will undergo segmental suture annuloplasty A modification of the De Vega technique that involves the use of two double-armed, pledgeted, 3-0 polytetrafluoroethylene sutures or Ethibond sutures. the first stitch of pledget-supported 2-0 Ethibond suture (Ethicon, Inc., Somerville, N.J.) is placed in the region of the septal commissure to protect the coronary sinus from injury. The next series of stitches are placed in a counterclockwise manner. The interrupted stitches follow the line that demarcates the tricuspid ring and are placed until the region of the anteroseptal commissure is reached. In general, 5 or 6 stitches need to be placed to complete the annuloplasty. The first suture is passed as a circular stitch in a counterclockwise direction from the posterior-septal commissure to the middle of the anterior leaflet. Deep bites are taken every 5 to 6 mm into the endocardium and fibrous ring at the junction of the tricuspid annulus and RV free wall. The first stitch will be placed using 2/0 pledgeted Ethibond suture in the region of the posteroseptal commissure to protect the coronary sinus from injury. The next series of 4 to 5 stitches will be placed in a counter-clockwise manner. The second limb of the first suture is run parallel to and 1 to 2 mm outside the previous suture in the same counter-clockwise direction. At the middle of the anterior leaflet, both sutures are placed through a second pledget. Another double-armed, pledgeted, 3-0 Gore-Tex or Ethibond suture is passed as a circular stitch in the same manner in a clockwise direction. 25
Control Group Tricuspid valve annuloplasty using other techniques 25 patients followed up to 3 years This mozaic grorup will include a combination of techniques ex ring annuloplasty, bicuspidization (kay's repair), pericardial strip annuloplasty Autologus Pericardial strip annuloplasty the first suture started at the commissure of coronary sinus and septal leaflet, and continued counterclockwise through the commissure of anterior and posterior leaflets. The second suture started at the commissure of anterior and septal and continued clockwise to commissure of anterior and posterior leaflets (Fig). The two felts are tied up to form a knot. The size of the tricuspid annulus was adjusted according to. Subsequently, fresh autologous pericardium tissue was sewed to the tricuspid leaflets. Kay’s repair (posterior suture annuloplasty) Kay’s technique involves an annulorrhaphy of the posterior segment. The resulting perpendicular forces on the tricuspid annulus in Kay’s repair obliterate the posterior tricuspid leaflet. The first arm of the support suture is placed along the posterior annulus. The second arm of the support suture completes the pledgeted mattress. Tricuspid Ring annuloplasty In this technique an annuloplasty ring or band was used. The options include the use of a rigid ring , flexible ring , or flexible band or 3D annuloplasty rings. The right size of the ring is chosen by measuring the distance from the antero-septal to postero-septal commissures (i.e., the surface of the anterior leaflet) and the ring is then implanted using eight to ten 2-0 Ti-cron stitches starting posteriorly (at the midpoint of the septal leaflet) and then proceeding counterclockwise. The surgeon must pay attention during the placement of stitches to damage the conduction system and to avoid the aortic root at the level of septal and anterior leaflet, respectively. The last stitch is placed above the antero-septal commissure, and the ring is finally parachuted and fixed. 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligible were (75) consecutive adult patients who will underwent tricuspid valve surgery with or without concomitant cardiac procedures for heart disease at our institution were be included and divided into three randomized groups: two groups of semicircular Annuloplasty techniques, plus a third group using other techniques. The decision in favor of or against tricuspid valve repair was at the discretion of the institutional heart team based on the operating surgeons’ and the cardiologist’s findings with special concern regarding the valve anatomy. ○ Adult Patient with tricuspid regurgitation. ○ Redo cardiac patients except previous tricuspid repair. ○ Patients with poor ventricular functions and pulmonary hypertension will be also included. ○ Patients with infective pathology. ○ Redo tricuspid valve repairs. ○ Pregnancy ○Refusing the enrollment in the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 08/08/2017 Mansoura University Institutional Research board
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Mansoura University Dakahlia 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Outcome measure was intraoperative and early postoperative include Repair failure measured by the degree of tricuspid regurgitation by echocardiography (None – mild – moderate – Severe). Intraopertative , 2 weeks, 6 months, 1 year , 2 years, 3 years
Secondary Outcome Secondary outcomes will include: Need for Pacemaker placement, Hospital morbidity and Mortality at 30 days, Cross clamp and cardiopulmonary bypass time, Ventilation time in hours, ICU stay in days, Hospital stay in days. Post-operative echo will be performed to determine the success of the repair and Post-operative patient symptoms will be reassessed regarding dyspnea according to NYHA class. Postoperative complications anticipated will include: Major Adverse Cardiac Events (MACEs), respiratory complications, wound infections, Need for surgical re-exploration, Arrhythmias, and Readmission within 30 days. Intraoperative , 2 weeks, 6 months, 1 year, 2 years, 3 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiocasvaular and thoracic surgery center Faculty of Medicine Mansoura University Gihan street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None Mansoura Dakahlia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Mansoura University Faculty of Medicine Mansoura University Cardiovascular and thoracic surgery center Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Monir El Saeid Mansoura Dakahlia Egypt
Sameh Mostafa Amer Mansoura Dakahlia Egypt
Mohammed AbdelFattah Sanad Mansoura Dakahlia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Beshir hatem.beshir@alexmed.edu.eg +201003711756 Luran
City Postal code Country Position/Affiliation
Alexandria 21411 Egypt Department of Cardiothoracic Surgery Faculty of Medicine Mansoura University
Role Name Email Phone Street address
Public Enquiries Hatem Beshir Hatem.beshir@alexmed.edu.eg +201003711756 Luran
City Postal code Country Position/Affiliation
Alexandria 21411 Egypt Department of Cardiothoracic Surgery Faculty of Medicine Mansoura University Egypt
Role Name Email Phone Street address
Scientific Enquiries Hatem Beshir Hatem.beshir@alexmed.edu.eg +201003711756 Luran
City Postal code Country Position/Affiliation
Alexandria 21411 Egypt Department of Cardiothoracic Surgery Faculty of Medicine Mansoura University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results area being analyzed . the final form of the study will be included after publication. Included will be individual participant clinical data after deindentificaiton, study protocol, informed consent forms, data will be available starting 4 months following publication up to 3 years. Data will be accessible to qualified researches for any purpose upon request. Clinical Study Report,Informed Consent Form,Study Protocol Full manuscript will be available in 2 to 4 months . Data requests can be submitted starting 4 months after article publication and the data will be made accessible for up to 36 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of the research and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact hatem.beshir@alexmed.edu.eg
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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